| Literature DB >> 24371452 |
Abstract
Background. SuperUlam is a proprietary blend of natural ingredients aimed at supporting brain health. We aimed to evaluate the effect of SuperUlam on attention and mood in healthy adults. Methods. Twenty healthy individuals aged 35-65 were enrolled in this randomized, double-blind, placebo-controlled, crossover study. Study duration was 3 weeks and consisted of 3 visits. Measurement of cognitive function included computer-based testing of reaction time, complex attention, working memory, sustained attention, and executive functioning. Mood testing was performed via the profile of mood states (POMS) survey and the Chalder fatigue scale. Results. Cognitive function testing demonstrated a significant improvement from baseline in executive functioning, cognitive flexibility, reaction time, and working memory in the product group only (P < 0.05). When comparing the study product to placebo, the data demonstrated a significant decrease in tension, depression, and anger (P < 0.05). There was no significant difference between the product and placebo in the other measures of mood, including vigor, fatigue, confusion, and total mood disturbance. No adverse events were reported. Conclusions. Supplementation with SuperUlam is safe to consume with potential benefits to cognitive function and mood.Entities:
Year: 2013 PMID: 24371452 PMCID: PMC3863557 DOI: 10.1155/2013/238454
Source DB: PubMed Journal: Evid Based Complement Alternat Med ISSN: 1741-427X Impact factor: 2.629
Inclusion and exclusion criteria.
| Inclusion criteria | Exclusion criteria |
|---|---|
| Age between 35–65 years | Active or history of substance or alcohol abuse |
| BMI between 18–30 kg/m2 | History of major depression, bipolar disorder, or schizophrenia |
| POMS score >15 at screening | Use of medications of ADD or ADHD |
| CNSVS score >6 at screening | Smoking |
| Caffeine intake of over four servings daily | |
| Use of any drugs or dietary supplements that may affect memory or mental performance | |
| Pregnant or lactating | |
| Any medical condition which in the opinion of the investigator might interfere with the subject's participation in the trial |
BMI: body mass index.
POMS: profile of mood states.
CNSVS: CNS vital signs.
SuperUlam ingredients.
| SuperUlam Capsule | |
|---|---|
| Extracts | |
| Sireh extract | 150 mg |
| Turmeric extract | 50 mg |
| Pegaga extract | 100 mg |
| Curry leaf extract | 50 mg |
| Selasih extract | 50 mg |
| Kesum extract | 150 |
| Ulam Raja extract | 25 mg |
| Tocobeads | 25 mg |
| Ascorbic Acid | 36 mg |
| Vitamin E 50% CWS/S | 8 mg |
|
| |
| Other Ingredients | |
| Microcrystalline cellulose PH102 | 194 mg |
| Calcium phosphate dibasic dihydrate | 68 mg |
| Sodium starch glycolate | 25 mg |
| Glyceryl behenate | 37 mg |
| Colloidal silicon dioxide | 27 mg |
|
| |
| Coating | |
| Hydroxypropylmethylcellulose | 14.9 |
| Glycerin | 5 mg |
| Chlorophyll, sodium copper complex | 0.56 mg |
| Carnauba wax | 0.12 mg |
| Titanium oxide | 8.9 mg |
Scoring system for CNSVSS, POMS, and Chalder scales.
| Scales and scoring | Definition | Units and normal range | Explanation |
|---|---|---|---|
| CNS vital signs | |||
| Cognitive flexibility | Measure of frontal lobe functioning | Milliseconds Age-dependent | A higher value represents a higher level of functioning |
| Reaction time | Average measure of two distinct attention components | Milliseconds Age-dependent | A higher score represents a longer reaction time |
| Complex attention | Combined measure of simple, choice, and shifting attention elements | Milliseconds Age-dependent | A higher score represents a higher level of attention |
| Working memory | Measures well-known “2-back” working memory | Milliseconds Age-dependent | A higher score represents a higher level of working memory |
| Sustained attention | Combined measure of three cascading attention tests each slightly more difficult than the previous. | Milliseconds Age-dependent | A higher score represents a higher level of sustained attention |
| Executive functioning | Measure of how well a subject deals with making correct decisions in a shifting rule and target environment | Milliseconds Age-dependent | A higher score represents a higher level of executive functioning |
| Processing speed | Scores how well a subject deals with moving across a keyboard based on keys and stimuli | Milliseconds Age-dependent | A higher score represents a longer processing speed |
| Average standard score | Composite score of overall cognitive function | Milliseconds Age-dependent | A higher score represents a higher level of overall cognitive function |
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| |||
| POMS scoring | |||
| Tension | Assess transient, distinct mood state of tension | 0–4 Likert scale No normal range | A higher score indicates that subject tends to be fidgety, restless, and quickly frustrated with people |
| Depression | Assess transient, distinct mood state of depression | 0–4 Likert scale No normal range | A higher score indicates that subject feels complete and utter loss of hope and unable to carry out normal activities |
| Anger | Assess transient, distinct mood state of anger | 0–4 Likert scale No normal range | A higher score indicates the subject's intensity of expressing anger at a particular time |
| Vigor | Assess transient, distinct mood state of vigor | 0–4 Likert scale No normal range | A higher score indicates that the subject is feeling cheerful, lively, alert, active, and carefree |
| Fatigue | Assess transient, distinct mood state of fatigue | 0–4 Likert scale No normal range | A higher score indicates more severe fatigue, fatigue distress, or impact on activities of daily living |
| Confusion | Assess transient, distinct mood state of confusion | 0–4 Likert scale No normal range | A higher score indicates that subject tends to feel mixed up and confused either with instructions or surrounding environment |
| Total mood disturbance | Composite score of distressed mood states | 0–4 Likert scale No normal range | A higher score indicates anxiety, emotional suppression, and psychological distress |
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| |||
| Chalder scales | |||
| Total physical | Self-rated 8-question scale of physical symptoms | 0–3 Likert scale No normal range | High scores indicate an increased risk for cardiovascular diseases |
| Total mental | Self-rated 6-question scale regarding mental fatigue | 0–3 Likert scale No normal range | High scores indicate presence of anxiety and depression |
Figure 1Study attrition chart.
Demographic data.
| Baseline characteristics | Male | Female |
|---|---|---|
|
| 10 | 10 |
| Age (mean) | 47.7 | 47.6 |
| Age (range) | 36–65 | 43–54 |
| Weight in lbs (mean) | 193.1 | 155.3 |
| Weight in lbs (range) | 169–216 | 120–190 |
| BMI (mean) | 27.2 | 26.4 |
| BMI (range) | 25–30 | 24–30 |
| Menopausal % | NA | 20% |
| Marital status | ||
| Single | 1 | 0 |
| Married | 7 | 8 |
| Divorced | 0 | 2 |
| Separated | 2 | 0 |
| Widowed | 0 | 0 |
| Domestic partner | 0 | 0 |
| Ethnicity | ||
| White | 3 | 2 |
| Asian | 0 | 0 |
| African-American | 1 | 0 |
| Hispanic/Latino | 6 | 8 |
| American Indian/Alaska Native | 0 | 0 |
| Hawaiian/Pacific Islander | 0 | 0 |
| Other | 0 | 0 |
Effect of treatment on CNS vital signs testing.
| Units (ms) | Baseline (mean ± SE) | Hour 1 (mean ± SE) | Hour 2 (mean ± SE) | Hour 3 (mean ± SE) | Hour 4 (mean ± SE) | Hour 5 (mean ± SE) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SuperUlam | Placebo | SuperUlam | Placebo | SuperUlam | Placebo | SuperUlam | Placebo | SuperUlam | Placebo | SuperUlam | Placebo | |
| Cognitive flexibility | 115.25 ± 2.07 | 111.60 ± 3.37 | 116.45 ± 1.63 | 115.70 ± 3.75 | 112.35 ± 5.11 | 112.60 ± 3.60 | 118.90 ± 1.75 | 113.45 ± 3.42 | 119.75 ± 1.60 | 117.55 ± 2.26 | 117.25 ± 2.27 | 116.85 ± 2.37 |
| Reaction time | 104.25 ± 2.66 | 100.65 ± 3.24 | 101.95 ± 2.97 | 99.25 ± 3.24 | 100.45 ± 3.19 | 106.60 ± 3.76 | 103.25 ± 3.14 | 100.90 ± 2.98 | 100.90 ± 3.56 | 101.15 ± 3.65 | 101.60 ± 3.51 | 102.55 ± 2.90 |
| Complex attention | 106.65 ± 2.36 | 101.40 ± 3.94 | 108.75 ± 1.56 | 106.80 ± 3.22 | 101.50 ± 5.93 | 98.50 ± 5.39 | 106.70 ± 2.58 | 96.60 ± 5.68 | 110.15 ± 7.55 | 104.65 ± 3.15 | 106.20 ± 2.29 | 105.10 ± 3.50 |
| Working memory | 97.05 ± 2.79 | 97.95 ± 4.02 | 97.20 ± 2.58 | 97.50 ± 3.49 | 98.25 ± 3.11 | 95.75 ± 3.67 | 99.35 ± 2.99 | 96.70 ± 3.44 | 98.40 ± 3.80 | 96.55 ± 3.25 | 102.15 ± 3.06 | 95.35 ± 4.28 |
| Sustained attention | 97.25 ± 3.45 | 97.30 ± 4.08 | 97.75 ± 3.30 | 99.05 ± 3.27 | 97.65 ± 2.44 | 94.60 ± 4.16 | 96.15 ± 4.30 | 97.20 ± 3.35 | 99.90 ± 3.79 | 96.70 ± 3.72 | 97.25 ± 4.47 | 95.30 ± 3.98 |
| Executive functioning | 115.95 ± 2.03 | 112.45 ± 3.46 | 116.60 ± 1.60a | 116.05 ± 3.80 | 112.85 ± 5.10 | 114.40 ± 3.42 | 118.95 ± 1.68 | 114.45 ± 3.43 | 120.15 ± 1.57 | 118.20 ± 2.19 | 117.90 ± 2.08 | 117.05 ± 2.26 |
| Processing speed | 108.70 ± 3.02 | 103.85 ± 2.98 | 108.35 ± 3.52 | 109.75 ± 3.81 | 115.75 ± 3.34 | 114.40 ± 3.08 | 113.60 ± 2.85 | 112.45 ± 3.72 | 117.25 ± 3.57 | 115.40 ± 2.96 | 117.90 ± 2.67 | 115.40 ± 3.62 |
| Average standard score | 106.46 ± 1.83 | 103.60 ± 2.48 | 106.72 ± 1.72 | 106.30 ± 2.46 | 105.54 ± 3.15 | 105.27 ± 2.34 | 108.15 ± 1.63 | 104.53 ± 2.67 | 109.51 ± 1.73 | 107.16 ± 2.08 | 108.62 ± 1.69 | 106.81 ± 1.82 |
a P < 0.05 versus placebo at this time point.
Effect of treatment on POMS.
| POMS | Baseline (mean ± SE) | Hour 1 (mean ± SE) | Hour 2 (mean ± SE) | Hour 3 (mean ± SE) | Hour 4 (mean ± SE) | Hour 5 (mean ± SE) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SuperUlam | Placebo | SuperUlam | Placebo | SuperUlam | Placebo | SuperUlam | Placebo | SuperUlam | Placebo | SuperUlam | Placebo | |
| Tension | 0.30 ± 0.15 | 0.40 ± 0.18 | 0.25 ± 0.12 | 0.35 ± 0.15 | 0.10 ± 0.07a | 0.35 ± 0.15 | 0.25 ± 0.16 | 0.70 ± 0.41 | 0.15 ± 0.11 | 0.35 ± 0.15 | 0.25 ± 0.12 | 0.20 ± 0.16 |
| Depression | 0.10 ± 0.10 | 0.20 ± 0.16 | 0.25 ± 0.25 | 0.20 ± 0.12 | 0.20 ± 0.20 | 0.10 ± 0.07 | 0.05 ± 0.05 | 0.15 ± 0.11 | 0.00 ± 0.00b | 0.10 ± 0.10 | 0.00 ± 0.00a | 0.10 ± 0.07 |
| Anger | 0.15 ± 0.11 | 0.05 ± 0.05 | 0.25 ± 0.18 | 0.35 ± 0.15 | 0.25 ± 0.18b | 0.05 ± 0.05 | 0.00 ± 0.00b | 0.15 ± 0.15 | 0.00 ± 0.00b | 0.10 ± 0.10 | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Vigor | 8.60 ± 1.30 | 8.15 ± 1.20 | 8.10 ± 1.26 | 7.00 ± 1.16 | 8.95 ± 1.42 | 8.00 ± 1.34 | 8.95 ± 1.39 | 7.70 ± 1.27 | 8.80 ± 1.41 | 8.55 ± 1.30 | 8.70 ± 1.42 | 8.00 ± 1.19 |
| Fatigue | 0.85 ± 0.35 | 1.00 ± 0.31 | 1.30 ± 0.65 | 1.00 ± 0.41 | 1.10 ± 0.67 | 0.90 ± 0.35 | 0.50 ± 0.19 | 0.80 ± 0.44 | 0.45 ± 0.20 | 0.75 ± 0.42 | 0.45 ± 0.20 | 0.45 ± 0.24 |
| Confusion | 2.55 ± 0.39 | 2.40 ± 0.30 | 2.30 ± 0.31 | 2.55 ± 0.34 | 2.50 ± 0.60 | 2.40 ± 0.30 | 2.10 ± 0.31 | 2.75 ± 0.44 | 2.25 ± 0.32 | 2.45 ± 0.36 | 2.35 ± 0.32 | 2.25 ± 0.30 |
| Total mood disturbance | −4.65 ± 1.75 | −4.10 ± 1.57 | −3.75 ± 2.18 | −2.55 ± 1.72 | −4.80 ± 2.57 | −4.20 ± 1.70 | −6.05 ± 1.74 | −3.15 ± 2.10 | −5.95 ± 1.69 | −4.80 ± 1.89 | −5.65 ± 1.72 | −5.00 ± 1.49 |
a P < 0.01 versus placebo at this time point; b P < 0.05 versus placebo at this time point.
Effect of treatment on the Chalder fatigue scale.
| Baseline (mean ± SE) | Hour 1 (mean ± SE) | Hour 2 (mean ± SE) | Hour 3 (mean ± SE) | Hour 4 (mean ± SE) | Hour 5 (mean ± SE) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SuperUlam | Placebo | SuperUlam | Placebo | SuperUlam | Placebo | SuperUlam | Placebo | SuperUlam | Placebo | SuperUlam | Placebo | |
| Total physical | 7.65 ± 0.70 | 7.50 ± 0.52 | 8.15 ± 0.96 | 8.10 ± 0.74 | 7.95 ± 1.10 | 7.15 ± 0.62 | 7.10 ± 0.87 | 7.35 ± 0.70 | 6.25 ± 0.86 | 5.85 ± 0.79 | 6.80 ± 0.78 | 6.35 ± 0.66 |
| Total mental | 5.15 ± 0.53 | 5.15 ± 0.47 | 5.25 ± 0.63 | 5.35 ± 0.52 | 5.35 ± 0.61 | 5.00 ± 0.52 | 4.90 ± 0.64 | 5.05 ± 0.48 | 4.20 ± 0.59 | 4.45 ± 0.59 | 4.65 ± 0.47 | 4.50 ± 0.56 |