Wendy J Dahl1, Arnelle R Wright1, Gretchen J Specht1, Mary Christman2, Anne Mathews1, Diederick Meyer3, Thomas Boileau4, Holly J Willis4, Bobbi Langkamp-Henken1. 1. Food Science and Human Nutrition Department , University of Florida , 359 FSHN Building, Newell Drive, Gainesville, FL 32611 , USA. 2. MCC Statistical Consulting LLC , 2219 NW 23rd Terrace, Gainesville, FL 32605 , USA. 3. Sensus B.V. , PO Box 1308, 4700 BH Roosendaal , The Netherlands. 4. General Mills Bell Institute of Health and Nutrition , 9000 Plymouth Avenue North, Golden Valley, MN 55427 , USA.
Abstract
The impact ofoligofructose (OF) intake on stool frequency has not been clearly substantiated, while significant gastrointestinal (GI) symptoms have been reported in some individuals. The aim of the present study was to determine the effects ofOF on stool frequency and GI symptoms in healthy adults. In an 8-week, randomised, double-blind, parallel-arm study, ninety-eight participants were provided with 16 g OF in yogurt and snack bars (twenty male and thirty female) or matching control foods (seventeen male and thirty-one female), to incorporate, by replacement, into their usual diets. Participants completed a daily online questionnaire recording stool frequency and rating four symptoms: bloating, flatulence, abdominal cramping and noise, each on a Likert scale from '0' for none (no symptoms) to '6' for very severe, with a maximum symptom intensity score of 24 (sum of severities from all four symptoms). Online 24 h dietary recalls were completed during pre-baseline and weeks 4, 6 and 8 to determine fibre intake. When provided with OF foods, fibre intake increased to 24·3 (sem 0·5) g/d from pre-baseline (12·1 (sem 0·5) g/d; P < 0·001). Stool frequency increased with OF from 1·3 (sem 0·2) to 1·8 (sem 0·2) stools per d in males and 1·0 (sem 0·1) to 1·4 (sem 0·1) stools per d in females during intervention weeks compared with pre-baseline (P < 0·05),but did not change for control participants (males: 1·6 (sem 0·2) to 1·8 (sem 0·2); females: 1·3 (sem 0·1) to 1·4 (sem 0·1)). Flatulence was the most commonly reported symptom. Mean GI symptom intensity score was higher for the OF group (3·2 (sem 0·3)) v. control (1·7 (sem 0·1)) (P < 0·01), with few participants reporting above moderate symptoms. No change in symptom intensity occurred over time. Consuming yogurt and snack bars with 16 g OF improves regularity in young healthy adults. However, GI symptoms, resulting from an increase in oligofructose intake, may not diminish with time.
RCT Entities:
The impact of oligofructose (OF) intake on stool frequency has not been clearly substantiated, while significant gastrointestinal (GI) symptoms have been reported in some individuals. The aim of the present study was to determine the effects of OF on stool frequency and GI symptoms in healthy adults. In an 8-week, randomised, double-blind, parallel-arm study, ninety-eight participants were provided with 16 g OF in yogurt and snack bars (twenty male and thirty female) or matching control foods (seventeen male and thirty-one female), to incorporate, by replacement, into their usual diets. Participants completed a daily online questionnaire recording stool frequency and rating four symptoms: bloating, flatulence, abdominal cramping and noise, each on a Likert scale from '0' for none (no symptoms) to '6' for very severe, with a maximum symptom intensity score of 24 (sum of severities from all four symptoms). Online 24 h dietary recalls were completed during pre-baseline and weeks 4, 6 and 8 to determine fibre intake. When provided with OF foods, fibre intake increased to 24·3 (sem 0·5) g/d from pre-baseline (12·1 (sem 0·5) g/d; P < 0·001). Stool frequency increased with OF from 1·3 (sem 0·2) to 1·8 (sem 0·2) stools per d in males and 1·0 (sem 0·1) to 1·4 (sem 0·1) stools per d in females during intervention weeks compared with pre-baseline (P < 0·05),but did not change for control participants (males: 1·6 (sem 0·2) to 1·8 (sem 0·2); females: 1·3 (sem 0·1) to 1·4 (sem 0·1)). Flatulence was the most commonly reported symptom. Mean GI symptom intensity score was higher for the OF group (3·2 (sem 0·3)) v. control (1·7 (sem 0·1)) (P < 0·01), with few participants reporting above moderate symptoms. No change in symptom intensity occurred over time. Consuming yogurt and snack bars with 16 g OF improves regularity in young healthy adults. However, GI symptoms, resulting from an increase in oligofructose intake, may not diminish with time.
Entities:
Keywords:
Fibre; Gastrointestinal symptoms; Oligofructose; Stool frequency
In the USA, food processing and dietary preferences have resulted in fibre intakes far below
recommendations. Americans currently consume less than half of the adequate intake for
fibre(
) (14 g fibre/4200 kJ (1000 kcal))(
), an intake level that is associated with functional gastrointestinal
disturbances such as constipation(
). In an attempt to meet consumer demand for foods higher in fibre and to
increase total fibre intake, foods with added fibre have become ubiquitous in the North
American food supply, with fructans (inulin, oligofructose and fructo-oligosaccharides) being
commonly added fibres(
).As many as 10 % of women and 4 % of men self-report constipation(
); thus consumers may be seeking foods with added fibre to improve bowel
habit. Although fructans have lower faecal bulking capacity compared with less fermentable
fibres such as wheat bran(
), there is evidence that inulin may improve bowel function in constipated
adults(
,
). However, it is not known if oligofructose, with its lower chain length,
has a similar effect as longer-chain inulin, and if this effect can be demonstrated
independent of low stool frequency.Fermentation of undigested carbohydrate generates gas(
), and oligosaccharides, due to their rapid fermentation(
), may contribute to flatulence and bloating. Briet et
al.(
) evaluated gastrointestinal symptoms of fructo-oligosaccharide consumption
and found that excessive flatulence was apparent at doses of >30 g/d, bloating
at >40 g/d, and abdominal cramps and diarrhoea at >50 g/d. In a review of the
safety and tolerance of fructans, it was suggested that up to 20 g per d of inulin and
oligofructose are well tolerated(
). However, more recent studies have suggested that the tolerance threshold
may be as low as 10 g/d for inulin and 5 g/d for oligofructose(
).Comparing tolerance among studies is difficult, given that the gastrointestinal symptoms
assessed and methodology used to rate severity differ. Carabin &
Flamm(
) noted that flatulence, bloating, abdominal distention and rumbling are
commonly reported for inulin and oligofructose. Grabitske & Slavin(
) reported that flatulence, distension, loose stools and stool frequency
were observed in studies investigating tolerance to fructans. Bruhwyler et
al.(
) evaluated the tolerance of fructans, assessing flatulence, rumbling,
bloating, abdominal pain, abdominal cramps and nausea, using visual analogue scales from 0 mm
corresponding to ‘no symptoms’ to 100 mm corresponding to ‘unbearable symptoms’, as well as an
assessment of stool frequency and stool consistency. More recently, Bonnema et
al.(
) assessed seven symptoms including gas/bloating, nausea, flatulence,
gastrointestinal cramping, diarrhoea, constipation and gastrointestinal rumbling using a
four-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe)(
). The symptoms of flatulence, bloating/distension, noise/rumbling and
gastrointestinal cramping are the most commonly reported symptoms to assess gastrointestinal
tolerance of fructans, whereas nausea, not reported following oligofructose intake, may not be
relevant for tolerance assessment. While both constipation and diarrhoea are commonly defined,
in part, by stool frequency(
), this objective measurement may be a more reliable indicator than
self-reporting of these symptoms.Foods with added fibre may provide a practical means of achieving fibre recommendations in
North America. With widespread fructan intake, further evidence is needed related to the
outcome measures of stool frequency and tolerance in healthy individuals. The aim of the
present study was to determine the effect of consuming two foods per d, containing a total of
16 g oligofructose, on stool frequency and gastrointestinal symptoms in healthy adults
compared with similar foods with no added fibre.
Experimental methods
Participants
Study participants were recruited from a university community through word of mouth,
flyers, posters and announcements during autumn 2011. Inclusion criteria to examine both
outcomes included: between the ages of 18 and 50 years, BMI between 23 and
30 kg/m2, a usual fibre intake of less than 20 g/d, weight stable (no loss or
gain greater than 5 lb (2·3 kg) within the past 3 months) and habitual breakfast consumers
(defined as eating breakfast within 2 h of waking at least 5 d per week). Exclusion
criteria included: higher eating restraint (i.e. a score equal to or greater than 14 on
the Eating Inventory questionnaire)(
); postmenopausal (self-reported no menstrual period for 1 year);
current smokers or tobacco users; not willing to discontinue prebiotic/fibre supplements
or probiotic supplements; use of an antibiotic within 2 months before the study start;
have known food allergies; have a physician-diagnosed gastrointestinal disease/condition
other than gastro-oesophageal reflux disease, constipation or diverticular disease; were
taking prescriptions other than oral contraceptives, seasonal allergy medications,
cholesterol- or blood pressure-lowering medications, vitamins or minerals, and baby
aspirin; having greater than two alcoholic beverages per d; participating in purposeful
exercise for more than 5 h per week; or being a lactating or pregnant female. The present
study was conducted according to the guidelines laid down in the Declaration of Helsinki
and all procedures involving human subjects were approved by the University of Florida's
Institutional Review Board 1 (IRB-01). Written informed consent was obtained from all
participants.
Experimental design
The study was an 8-week, randomised, double-blind, controlled, parallel-arm study. The
present study was part of a larger study (n 200) designed to detect a
500 kJ difference between intervention groups with 80 % power, an α of 0·05, good blocking
(0·4 correlations) and 15 % attrition rate. During the pre-baseline week, and during weeks
4, 6 and 8, participants recorded their daily dietary intake using the Automated
Self-Administered 24 hour Recall (ASA24) system(
). Baseline data were used to determine their average daily fibre and
energy intake for the purposes of inclusion/exclusion and for stratification,
respectively. Demographic data were also collected. Participants were randomised in
blocks, with blocks being three different energy ranges for males (6·3–8·4 MJ (1500–2000
kcal), 8·4–10·9 MJ (2001–2600 kcal), >10·9 MJ (>2600 kcal)) and females
(5·0–7·5 MJ (1200–1800 kcal), 7·5–10·0 MJ (1801–2400 kcal), >10·0 MJ (>2400
kcal)). The randomisation blocks and sealed envelopes containing subject assignments were
prepared by the study statistician who did not have contact with the participants.
Participants were provided with snack bars and yogurts to consume daily that, for the
intervention group only, contained 16·4 g added oligofructose (8·4 g for study snack bars
and 8·0 g for study yogurts). Table 1 gives the
nutrient contents of the snack bars and yogurt. To provide a period of adaptation,
participants were instructed to consume one snack bar per d during week 1, and one snack
bar plus one yogurt from week 2 to the final week. Every 2 weeks, participants picked up
the study foods for the upcoming weeks.
Table 1.
Energy and nutrient content of yogurt and snack bars
Description
Weight (g)
Energy (kJ)
Carbohydrate (g)
Protein (g)
Fat (g)
Fibre (g)
Snack bar
Control
38
599
31·8
1·5
1·0
0·5
Oligofructose
40
620
32·6
1·5
1·4
8·8*
Yogurt
Control
170
448
19·5
6·8
0·2
0·1
Oligofructose
170
461
24·2
6·7
0·2
8·0
* Contained 8·4 g oligofructose.
Energy and nutrient content of yogurt and snack bars* Contained 8·4 g oligofructose.Daily questionnaires, during the pre-baseline period and throughout the intervention
period, were sent to each participant's email address or smart phone using Qualtrics
Survey Software (Qualtrics Labs Inc.) along with electronic reminders to complete the
questionnaires from study coordinators. The gastrointestinal symptom questionnaire was
modified from Bonnema et al.(
) by increasing the symptom rating scale to a seven-point scale
recommended for subjective measures of symptoms(
). Participants rated the intensity of gastrointestinal symptoms using a
scale from 0 (none) to 6 (very severe) for bloating, flatulence, abdominal cramping and
noises. The daily gastrointestinal symptom intensity score was defined as the sum of
individual intensity scores from the four symptoms, with a maximum symptom severity score
of 24. In addition, participants were asked to report daily stool frequency, the amount of
each study food that they consumed, and whether they took an antibiotic. Once a
participant reported that they started a course of antibiotics, their daily data from that
point forward were not included in the analyses.
Statistical analyses
Study data were analysed as intent to treat. Food fibre (from non-study foods) and total
fibre were analysed using a linear mixed model with fixed effects of time period and
treatment and a random effect to capture correlation among observations on the same
subject within each time period, and a compound symmetry covariance structure for the
residuals was completed to capture the repeated observations on each subject across
periods.The daily gastrointestinal symptom intensity score was averaged across each week for each
subject. A generalised linear mixed model was then used to look for the effect of the
intervention (control, oligofructose), sex and week of study (pre-baseline and
intervention weeks 1 to 8) on gastrointestinal symptom intensity. A repeated-measures
effect was included in the model to account for the repeated sampling on the same
individual. Weekly scores were log-transformed to approximate a normal distribution and
stabilise variance. The Kenward–Roger method(
) was used to account for the effect of small sample bias in the
repeated measures covariance estimates on hypothesis testing. The Tukey–Kramer method was
used to control family-wise error rate in pairwise comparisons of means. Pairwise
comparisons of weeks within each intervention were also performed in order to test for
changes through time within an intervention, again adjusting for experiment-wise error
rates using the Tukey–Kramer method. Daily scores for each symptom individually and stool
frequencies were also analysed by averaging each week for each subject and then performing
a generalised linear model as described above. A check of the assumptions indicated that
bloating, cramping and noises required a log-transformation in order to obtain approximate
normality. Probability of reporting at least one symptom (i.e. an intensity
score >0 for at least one symptom) and the probability of reporting all four
symptoms were estimated by analysing daily indicator variables (for example, yes = 1 if
any symptoms reported and = 0 otherwise) using logistic repeated-measures mixed models
with fixed effects of study group, sex and week of study and a repeated-measures effect to
allow for repeated observations on the same individual. Mean differences in demographic
data, daily intake of study foods and stool number by study group and sex were analysed
using a two-way ANOVA and the Holm–Sidak All Pairwise Multiple Comparison Procedure.
Unless stated otherwise, data are presented as mean values with their standard errors,
with significance denoted at P < 0·05. Statistical analyses were
completed using SAS (version 9.2; SAS Institute Inc.) or SigmaPlot (version 11.0, 2008;
Systat Software Inc.).
Results
Informed consent was obtained from 207 potential participants (Fig. 1). Of these, 109 did not meet inclusion/exclusion criteria, for
reasons such as excess exercise (n 10), a usual fibre intake of over 20 g/d
(n 22), BMI out of range (n 25), disordered eating
(n 20), under-reporting of energy intake (n 16), and
other (n 11). Of the ninety-eight participants randomised, ninety-seven
completed all 56 d of the study protocol. One participant voluntarily withdrew from the
study after 6 d due to excessive gastrointestinal disturbances. This participant consumed
the oligofructose-containing bar for the first 3 d only and reported an average
gastrointestinal symptom intensity score of 11 of a possible 24. During the study, seven
participants began a course of antibiotics and their data were not included in the analyses
from the first day of antibiotics until the end of the study. Of these participants, five
were receiving the control foods, and antibiotics were started on day 16, 22, 34, 39 and 40.
Two of the participants were consuming the oligofructose-containing foods, and antibiotics
were started on days 22 and 41. Due to sex differences in gastrointestinal symptom data and
stool frequency, data are reported by study group and sex.
Fig. 1.
Participant flow diagram.
Participant flow diagram.The majority of the participants were white. Mean age and BMI were not different between
study groups or sex (Table 2). Overall,
participants completed 95 (sem 1) % of the daily questionnaires and reported that
they consumed 96 (sem 1) % of the study foods for a mean intake of 15·4
(sem 0·3) g oligofructose/d for those randomised to the oligofructose-containing
foods. Mean daily intake of oligofructose from the study foods was not different between
sexes (Table 2).
Table 2.
Participant characteristics, study food and oligofructose intake*
(Mean values with their standard errors, or numbers of subjects and percentages)
Males
Females
Control
Oligofructose
Control
Oligofructose
Mean
sem
Mean
sem
Mean
sem
Mean
sem
Subjects (n)
17
20
31
30
Age (years)
24·2
1·6
25·3
1·5
24·6
1·2
22·9
1·2
Daily questionnaires completed (%)
98·6
2·2
89·1
2·0
96·4
1·6
97·1
1·7
Race/ethnicity
White
n
11
13
15
13
%
65
65
48
43
Hispanic
n
4
3
3
5
%
24
15
10
17
Asian
n
2
2
4
3
%
12
10
13
10
Black
n
0
2
6
9
%
0
10
19
30
Other
n
0
0
3
0
%
0
0
10
0
BMI (kg/m2)
25·3
0·5
25·9
0·5
25·4
0·4
25·5
0·4
Study foods per d (%)
97·3
2·2
95·3
2·0
97·1
1·6
94·0
1·6
Study bars per d (%)
96·9
2·5
94·5
2·3
99·4
1·9
96·5
1·9
Study yogurts per d (%)
97·8
3·8
96·1
3·5
94·4
2·8
92·6
2·9
Oligofructose intake (g/d)†
0
15·6
0·4
0
15·3
0·3
P values for sex, intervention group, or the interaction between
sex and intervention group effects were examined with no significant
sex × intervention interactions observed.
† Added oligofructose in bars and yogurts is from study weeks 2 to 8.
Participant characteristics, study food and oligofructose intake*(Mean values with their standard errors, or numbers of subjects and percentages)P values for sex, intervention group, or the interaction between
sex and intervention group effects were examined with no significant
sex × intervention interactions observed.† Added oligofructose in bars and yogurts is from study weeks 2 to 8.Mean total fibre intakes were not significantly different between the control and
oligofructose groups during pre-baseline (week 0) (Fig.
2). However, when comparing mean total fibre intake between the two groups during the
intervention period (weeks 4, 6 and 8), the oligofructose group consumed considerably more
fibre over time than the control group, as expected (P < 0·001).
While the oligofructose group increased their total fibre intake over the duration of the
study, the total fibre intake of the control group was consistently lower from baseline to
study completion.
Fig. 2.
Daily fibre intake from all foods (total fibre) or non-study foods (food fibre) by
study week in individuals receiving study foods without oligofructose (control) or
with oligofructose (intervention). ■, Food fibre (control); ,
total fibre (control); , food fibre (intervention); ,
total fibre (intervention). Values are means, with standard errors represented by
vertical bars. a,b,c,d Mean values with unlike letters were significantly
different (P < 0·01).
Daily fibre intake from all foods (total fibre) or non-study foods (food fibre) by
study week in individuals receiving study foods without oligofructose (control) or
with oligofructose (intervention). ■, Food fibre (control); ,
total fibre (control); , food fibre (intervention); ,
total fibre (intervention). Values are means, with standard errors represented by
vertical bars. a,b,c,d Mean values with unlike letters were significantly
different (P < 0·01).There was a significant three-way interaction between the intervention, sex and week
(P = 0·017) for mean stool frequency (Fig. 3). An increase in stool frequency was observed in females in the
oligofructose group after the addition of the first study food, i.e. from week 1 of the
intervention to week 8 compared with the pre-baseline week 0 (Fig. 3). Daily stool frequency increased for males consuming the
oligofructose study foods at week 2 (i.e. after the addition of the second study food) to
week 8 of the intervention compared with the pre-baseline week (Fig. 3).
Fig. 3.
Mean daily stool frequency by week. ●, Females (control); ○, females (oligofructose);
▴, males (control); ▵, males (oligofructose). Values are means, with standard errors
represented by vertical bars. Main effects: intervention group (I),
P = 0·5026; sex (S), P = 0·0067; week (W),
P < 0·0001; I × W, P = 0·0044; I × S × W,
P = 0·0170. * Mean value was significantly different from that of
females in the same group (P < 0·05). † Mean value was
significantly different from that at pre-baseline (week 0) for the same group
(P < 0·05). ‡ Mean value was significantly different from
that at week 1 for the same group (P < 0·05).
Mean daily stool frequency by week. ●, Females (control); ○, females (oligofructose);
▴, males (control); ▵, males (oligofructose). Values are means, with standard errors
represented by vertical bars. Main effects: intervention group (I),
P = 0·5026; sex (S), P = 0·0067; week (W),
P < 0·0001; I × W, P = 0·0044; I × S × W,
P = 0·0170. * Mean value was significantly different from that of
females in the same group (P < 0·05). † Mean value was
significantly different from that at pre-baseline (week 0) for the same group
(P < 0·05). ‡ Mean value was significantly different from
that at week 1 for the same group (P < 0·05).The probability of reporting at least one symptom or all four symptoms was considered.
There was a significant (P < 0·0001) three-way interaction among
intervention group, sex and week on the probability of reporting at least one out of four
symptoms. Males consuming both the oligofructose and the control foods had a higher
probability of reporting at least one symptom during all study weeks compared with that
reported during the pre-baseline period. There was no difference in the probability of
reporting at least one symptom at any time point for male participants consuming the
oligofructose v. control foods (Fig.
4(A)). Similarly, females in both study groups had a higher probability of reporting
at least one symptom during the study weeks compared with the pre-baseline period. However,
during study weeks 1, 7 and 8, females consuming the oligofructose had a higher probability
of reporting at least one symptom compared with females consuming the control foods.
Fig. 4.
Probability of reporting at least one of four gastrointestinal (GI) symptoms
(flatulence, bloating, abdominal cramping, or noises) (A) or all four symptoms (B) in
1 d during the pre-baseline (week 0) period and 8 weeks of intervention. Daily data
were averaged across each week for each participant. ●, Females (control); ○, females
(oligofructose); ▴, males (control); ▵, males (oligofructose). Values are least
squares means, with standard errors represented by vertical bars. For (A), main
effects: intervention group (I), P = 0·0718; sex (S),
P = 0·3409; week (W), P < 0·0001; I × S × W,
P < 0·0001. For B, main effects: intervention group (I),
P = 0·0846; sex (S), P = 0·9355; week (W),
P < 0·0001; I × S × W, P = 0·0032. * Mean
value was significantly different from that of the control for the same sex
(P < 0·05). † Mean values for all the weeks were significantly
different from that for the pre-baseline week (P < 0·05). ‡
Mean values for the study weeks 2, 3, 4, 5, 7 and 8 were significantly different from
that for the pre-baseline week (P < 0·05). § Mean values for
the study weeks 1, 2, 3 and 7 were significantly different from that for the
pre-baseline week (P < 0·05).
Probability of reporting at least one of four gastrointestinal (GI) symptoms
(flatulence, bloating, abdominal cramping, or noises) (A) or all four symptoms (B) in
1 d during the pre-baseline (week 0) period and 8 weeks of intervention. Daily data
were averaged across each week for each participant. ●, Females (control); ○, females
(oligofructose); ▴, males (control); ▵, males (oligofructose). Values are least
squares means, with standard errors represented by vertical bars. For (A), main
effects: intervention group (I), P = 0·0718; sex (S),
P = 0·3409; week (W), P < 0·0001; I × S × W,
P < 0·0001. For B, main effects: intervention group (I),
P = 0·0846; sex (S), P = 0·9355; week (W),
P < 0·0001; I × S × W, P = 0·0032. * Mean
value was significantly different from that of the control for the same sex
(P < 0·05). † Mean values for all the weeks were significantly
different from that for the pre-baseline week (P < 0·05). ‡
Mean values for the study weeks 2, 3, 4, 5, 7 and 8 were significantly different from
that for the pre-baseline week (P < 0·05). § Mean values for
the study weeks 1, 2, 3 and 7 were significantly different from that for the
pre-baseline week (P < 0·05).There was also a significant (P = 0·003) three-way interaction among
intervention group, sex and week on the probability of reporting all four symptoms (Fig. 4(B)). Compared with the pre-baseline period, males
had a higher probability of reporting all four symptoms during weeks 1 to 8 when consuming
the oligofructose and weeks 1, 2, 3 and 7 when consuming the control foods. During study
weeks 4, 5, 6 and 8, males consuming the oligofructose had a higher probability of reporting
all four symptoms than males consuming the control foods. Throughout the pre-baseline period
and the 8-week intervention, there was less than a 15 % probability that females reported
all four symptoms, and there was no difference between study groups. Compared with the
pre-baseline period, females consuming oligofructose had a significantly higher probability
of reporting all four symptoms during weeks 1 to 8 of the intervention, and those in the
control group had a higher probability during all weeks except weeks 1 and 6.There was no difference in the gastrointestinal symptom intensity score during the
pre-baseline (week 0) period between sex or intervention assignment. There was a significant
effect of oligofructose on the mean symptom intensity (Fig.
5), with those consuming oligofructose reporting a higher mean symptom intensity
score (i.e. sum of intensity from all four symptoms) during the intervention period. Mean
daily symptom intensity score was significantly higher for the oligofructose group during
all 8 weeks of the intervention compared with the pre-baseline period. There were no
differences in symptom intensity score between intervention weeks with the exception of
weeks 1 and 2 where the symptom intensity score was significantly higher at week 2
v. week 1 for those consuming the oligofructose. There was a three-way
interaction of study group, week and sex (P = 0·01; Fig. 5). For males consuming the oligofructose, the symptom intensity
score did not increase compared with the pre-baseline period until week 2 with the addition
of the second oligofructose-containing study food (P < 0·0001) and
remained elevated to week 8 (Fig. 5). The symptom
intensity score for males consuming the control foods was not different from the
pre-baseline period with the exception of study week 7 when a higher score was reported. The
symptom intensity score was significantly higher for males consuming the oligofructose
v. control foods during study weeks 2 to 6 and week 8. For females
consuming the oligofructose, the symptom intensity score significantly increased
(P < 0·0001) at study week 1 when they were consuming only one of
the study foods per d and was constant throughout the remainder of the 8-week study period
even after the addition of the second study food. For females consuming the control foods
the symptom intensity score was similar to that reported during the pre-baseline period. The
symptom intensity score was significantly (P < 0·05) higher for
women consuming the oligofructose v. control foods from study week 1 to 8.
Fig. 5.
Gastrointestinal (GI) symptom intensity scores during the pre-baseline (week 0) and
8-week intervention periods in males and females consuming the
oligofructose-containing or control foods. The daily GI symptom intensity score
represents the sum of symptom intensities (0 = no symptom to 6 = very severe symptoms)
for flatulence, bloating, abdominal cramping and stomach noises averaged across each
week for each participant. ●, Females (control); ○, females (oligofructose); ▴, males
(control); ▵, males (oligofructose). Data were analysed as log-normally distributed.
Values are back-transformed least squares means, with standard errors represented by
vertical bars. Main effects: intervention group (I), P = 0·0009; sex
(S), P = 0·9272; week (W), P < 0·0001;
I × S × W, P = 0·0095. * Mean value was significantly different from
that of the control for the same sex (P < 0·05). † Mean values
for all the weeks were significantly different from that for the pre-baseline week
(P < 0·05). ‡ Mean values for the study weeks 2 to 8 were
significantly different from that for the pre-baseline week
(P < 0·05). § Mean value for study week 7 was significantly
different from that for the pre-baseline week (P < 0·05).
Gastrointestinal (GI) symptom intensity scores during the pre-baseline (week 0) and
8-week intervention periods in males and females consuming the
oligofructose-containing or control foods. The daily GI symptom intensity score
represents the sum of symptom intensities (0 = no symptom to 6 = very severe symptoms)
for flatulence, bloating, abdominal cramping and stomach noises averaged across each
week for each participant. ●, Females (control); ○, females (oligofructose); ▴, males
(control); ▵, males (oligofructose). Data were analysed as log-normally distributed.
Values are back-transformed least squares means, with standard errors represented by
vertical bars. Main effects: intervention group (I), P = 0·0009; sex
(S), P = 0·9272; week (W), P < 0·0001;
I × S × W, P = 0·0095. * Mean value was significantly different from
that of the control for the same sex (P < 0·05). † Mean values
for all the weeks were significantly different from that for the pre-baseline week
(P < 0·05). ‡ Mean values for the study weeks 2 to 8 were
significantly different from that for the pre-baseline week
(P < 0·05). § Mean value for study week 7 was significantly
different from that for the pre-baseline week (P < 0·05).Mean daily symptom intensity scores for flatulence and noises were significantly higher
with oligofructose (Table 3). Males and females
consuming oligofructose reported higher symptom intensity scores for flatulence during week
8 of the intervention compared with those consuming the control foods. The symptom intensity
scores for noises were significantly higher at weeks 2, 4 and 5 of the intervention in
participants consuming the oligofructose v. the control foods. Of 5653
total participant days reported, moderate (defined as > 3 intensity rating) bloating
was reported in 1·4 % of control participant days compared with 3·0 % of oligofructoseparticipant days. Moderate flatulence was reported in 2·3 % of control participant days
v. 12·0 % treatment participant days. Moderate cramping was reported in
1·0 % control participant days v. 2·5 % of treatment participant days, and
moderate noises were reported in 0·61 % of control participant days v. 3·1
% treatment participant days.
Table 3.
Gastrointestinal symptom intensities in males and females consuming the control or
oligofructose-containing foods
(Least squares means (LSmeans) with their standard errors)
Males
Females
Control
Oligofructose
Control
Oligofructose
LSmean
sem
LSmean
sem
LSmean
sem
LSmean
sem
P*
Subjects (n)
17
20
31
30
Gastrointestinal symptom intensities per d†
Flatulence
I: <0·0001
Pre-baseline
0·7
0·1
0·7a
0·2
0·7b
0·1
0·6c
0·2
S: 0·372
Intervention (week 8)
1·0d
0·2
2·1a,d
0·3
0·8b,e
0·2
1·6c,e
0·2
W: <0·0001
I × S × W: 0·086
Bloating
I: 0·038
Pre-baseline
0·3
0·1
0·2
0·1
0·2
0·1
0·2
0·1
S: 0·852
Intervention (week 8)
0·4
0·2
0·8
0·3
0·4
0·1
0·9
0·2
W: 0·226
I × S × W: 0·469
Abdominal cramping
I: 0·166
Pre-baseline
0·1a
0·1
0·2
0·1
0·3a
0·1
0·2
0·1
S: 0·695
Intervention (week 8)
0·2b
0·1
0·8
0·3
0·3b
0·1
0·7
0·2
W: 0·759
I × S × W: 0·087
Noises
I: 0·076
Pre-baseline
0·3
0·1
0·3
0·1
0·4a
0·1
0·3
0·1
S: 0·808
Intervention (week 8)
0·3
0·2
0·8
0·3
0·4a
0·1
0·6
0·2
W: 0·611
I × S × W: 0·003
a,b,c,d,e Mean values within rows (sex and treatment) and columns (week)
with similar letters were significantly different (P <
0·05). Values without superscripts were not different from any other values within
rows or columns.
* P values for intervention group (I), sex (S), week (W) and their
interaction.
† The mean daily gastrointestinal symptom intensity score represents the sum of
symptom intensities (0 = no symptom to 6 = very severe symptoms).
Gastrointestinal symptom intensities in males and females consuming the control or
oligofructose-containing foods(Least squares means (LSmeans) with their standard errors)a,b,c,d,e Mean values within rows (sex and treatment) and columns (week)
with similar letters were significantly different (P <
0·05). Values without superscripts were not different from any other values within
rows or columns.* P values for intervention group (I), sex (S), week (W) and their
interaction.† The mean daily gastrointestinal symptom intensity score represents the sum of
symptom intensities (0 = no symptom to 6 = very severe symptoms).On the final questionnaire participants were asked to report which study group they thought
they were in (i.e. ‘fibre-supplemented group’ or ‘non-fibre-supplemented group’). Of those
participants consuming the control foods, 51 % thought they were in the control group and 49
% thought they were consuming the fibre-containing foods. Of those participants randomised
to the oligofructose-supplemented foods a significantly larger proportion (78 %;
P = 0·005) thought they were in the fibre-supplemented group. When the
responses from males and females were examined separately, males were not able to correctly
guess their assigned group (P = 0·16). A significantly larger proportion of
females (76 %) were able to correctly guess that they were consuming the fibre-supplemented
foods (P = 0·03).
Discussion
With the goal of recruiting participants with typical North American fibre intakes, we
excluded individuals with habitual fibre intakes of greater than 20 g/d. The mean fibre
intake during pre-baseline was 12·1 (sem 0·5) g/d, somewhat below the estimated US
fibre intake(
). The addition of two snacks with added oligofructose increased the mean
total fibre intake to 24·3 (sem 0·5) g/d, which nearly achieved the adequate intake
for fibre in this group. Providing low-fibre foods to the control group may have displaced
higher-fibre foods from their usual diet, as their fibre intakes decreased during the
intervention. The high compliance reported in the present study, similar in both control and
oligofructose groups, provides evidence that the oligofructose-fortified foods were
acceptable(
).Incorporating foods with 16 g oligofructose/d into the diets of healthy young adults
resulted in increased stool frequency. This is in contrast with the findings of Slavin
& Feirtag(
), who reported no change in stool frequency or other indicators of bowel
function, i.e. stool weight, intestinal transit time and consistency, with 20 g inulin in
young healthy males (n 12) consuming a controlled diet, suggesting that
their study may have been underpowered. However, the findings of the present study are in
agreement with two studies demonstrating improved bowel function with chicory inulin with
constipated subjects(
,
).The present study confirms that a significant increase in gastrointestinal symptoms,
particularly flatulence, results with the consumption of oligofructose, a finding that is in
agreement with previous studies(
). One participant withdrew from the study due to symptoms confirming that
perhaps about 1 % of healthy individuals may be ‘highly sensitive’ to rapidly fermentable
fibres(
,
). For the remaining participants, ‘above moderate’ symptoms were reported
on few days. In the oligofructose group, flatulence, the most commonly reported symptom, was
reported at >3 on only 12 % of days. In reference to limitations, the present study
included only healthy young participants. Older adults and children may respond differently
to a similar intake of oligofructose.Although it is commonly described that individuals adapt to increased fibre intake over
time with decreasing symptoms(
), the results of the present study challenge this assumption. Reported
symptoms with oligofructose consumption maintained the same level of intensity over time,
and no adaptation occurred. This finding is in agreement with that of Stone-Dorshow
& Levitt(
) who found that gas symptoms with an intake of 10 g
fructo-oligosaccharides did not change over a 12 d period(
). Adaptation, if defined as a decrease in gastrointestinal symptoms such
as flatulence over time, would be dependent on the microbiota shifts that occur with the
feeding of a fibre and resulting substrate availability and fermentation. However,
adaptation of the colonic microbiota is nebulous given that it is a dynamic system and
defining an endpoint of adaptation is uncertain. Significant shifts in bacterial
populations, that may make an impact on gas production and, therefore, gastrointestinal
symptoms, generally occur within the first 2 weeks of intervention(
). The present study, given its 8-week length, clearly demonstrates no
gastrointestinal symptom adaptation to oligofructose.
Conclusions
Oligofructose, with its positive impact on bowel habit when provided at 16 g/d, has
potential for improving population fibre intakes. On most participant days, oligofructose
produced mild to moderate symptoms. However, as one individual experienced enough
discomfort to stop the study, labelling and identification of foods with added fibre is
prudent.
Authors: F Briet; L Achour; B Flourié; L Beaugerie; P Pellier; C Franchisseur; F Bornet; J C Rambaud Journal: Eur J Clin Nutr Date: 1995-07 Impact factor: 4.016
Authors: Matthew Beke; Alyssa M Burns; Sydney Weir; Rebecca J Solch; Taylor C Judkins; Carmelo Nieves; Bobbi Langkamp-Henken Journal: Health Qual Life Outcomes Date: 2022-03-28 Impact factor: 3.186