BACKGROUND: Two potent weight loss therapies, a low-carbohydrate, ketogenic diet (LCKD) and orlistat therapy combined with a low-fat diet (O + LFD), are available to the public but, to our knowledge, have never been compared. METHODS:Overweight or obese outpatients (n = 146) from the Department of Veterans Affairs primary care clinics in Durham, North Carolina, were randomized to either LCKD instruction (initially, <20 g of carbohydrate daily) or orlistat therapy, 120 mg orally 3 times daily, plus low-fat diet instruction (<30% energy from fat, 500-1000 kcal/d deficit) delivered at group meetings over 48 weeks. Main outcome measures were body weight, blood pressure, fasting serum lipid, and glycemic parameters. RESULTS:The mean age was 52 years and mean body mass index was 39.3 (calculated as weight in kilograms divided by height in meters squared); 72% were men, 55% were black, and 32% had type 2 diabetes mellitus. Of the study participants, 57 of the LCKD group (79%) and 65 of the O + LFD group (88%) completed measurements at 48 weeks. Weight loss was similar for the LCKD (expected mean change, -9.5%) and the O + LFD (-8.5%) (P = .60 for comparison) groups. The LCKD had a more beneficial impact than O + LFD on systolic (-5.9 vs 1.5 mm Hg) and diastolic (-4.5 vs 0.4 mm Hg) blood pressures (P < .001 for both comparisons). High-density lipoprotein cholesterol and triglyceride levels improved similarly within both groups. Low-density lipoprotein cholesterol levels improved within the O + LFD group only, whereas glucose, insulin, and hemoglobin A(1c) levels improved within the LCKD group only; comparisons between groups, however, were not statistically significant. CONCLUSION: In a sample of medical outpatients, an LCKD led to similar improvements as O + LFD for weight, serum lipid, and glycemic parameters and was more effective for lowering blood pressure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00108524.
RCT Entities:
BACKGROUND: Two potent weight loss therapies, a low-carbohydrate, ketogenic diet (LCKD) and orlistat therapy combined with a low-fat diet (O + LFD), are available to the public but, to our knowledge, have never been compared. METHODS: Overweight or obese outpatients (n = 146) from the Department of Veterans Affairs primary care clinics in Durham, North Carolina, were randomized to either LCKD instruction (initially, <20 g of carbohydrate daily) or orlistat therapy, 120 mg orally 3 times daily, plus low-fat diet instruction (<30% energy from fat, 500-1000 kcal/d deficit) delivered at group meetings over 48 weeks. Main outcome measures were body weight, blood pressure, fasting serum lipid, and glycemic parameters. RESULTS: The mean age was 52 years and mean body mass index was 39.3 (calculated as weight in kilograms divided by height in meters squared); 72% were men, 55% were black, and 32% had type 2 diabetes mellitus. Of the study participants, 57 of the LCKD group (79%) and 65 of the O + LFD group (88%) completed measurements at 48 weeks. Weight loss was similar for the LCKD (expected mean change, -9.5%) and the O + LFD (-8.5%) (P = .60 for comparison) groups. The LCKD had a more beneficial impact than O + LFD on systolic (-5.9 vs 1.5 mm Hg) and diastolic (-4.5 vs 0.4 mm Hg) blood pressures (P < .001 for both comparisons). High-density lipoprotein cholesterol and triglyceride levels improved similarly within both groups. Low-density lipoprotein cholesterol levels improved within the O + LFD group only, whereas glucose, insulin, and hemoglobin A(1c) levels improved within the LCKD group only; comparisons between groups, however, were not statistically significant. CONCLUSION: In a sample of medical outpatients, an LCKD led to similar improvements as O + LFD for weight, serum lipid, and glycemic parameters and was more effective for lowering blood pressure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00108524.
Authors: Corrine I Voils; Cynthia J Coffman; Janet M Grubber; David Edelman; Azita Sadeghpour; Matthew L Maciejewski; Jamiyla Bolton; Alex Cho; Geoffrey S Ginsburg; William S Yancy Journal: J Gen Intern Med Date: 2015-04-16 Impact factor: 5.128
Authors: Gary D Foster; Holly R Wyatt; James O Hill; Angela P Makris; Diane L Rosenbaum; Carrie Brill; Richard I Stein; B Selma Mohammed; Bernard Miller; Daniel J Rader; Babette Zemel; Thomas A Wadden; Thomas Tenhave; Craig W Newcomb; Samuel Klein Journal: Ann Intern Med Date: 2010-08-03 Impact factor: 25.391
Authors: Matthew J Crowley; David Edelman; Corrine I Voils; Matthew L Maciejewski; Cynthia J Coffman; Amy S Jeffreys; Marsha J Turner; Leslie A Gaillard; Teresa A Hinton; Elizabeth Strawbridge; Jennifer Zervakis; Anna Beth Barton; William S Yancy Journal: Contemp Clin Trials Date: 2017-04-23 Impact factor: 2.226
Authors: M Caprio; M Infante; E Moriconi; A Armani; A Fabbri; G Mantovani; S Mariani; C Lubrano; E Poggiogalle; S Migliaccio; L M Donini; S Basciani; A Cignarelli; E Conte; G Ceccarini; F Bogazzi; L Cimino; R A Condorelli; S La Vignera; A E Calogero; A Gambineri; L Vignozzi; F Prodam; G Aimaretti; G Linsalata; S Buralli; F Monzani; A Aversa; R Vettor; F Santini; P Vitti; L Gnessi; U Pagotto; F Giorgino; A Colao; A Lenzi Journal: J Endocrinol Invest Date: 2019-05-20 Impact factor: 4.256
Authors: Pamela A Shaw; William S Yancy; Lisa Wesby; Victoria Ulrich; Andrea B Troxel; David Huffman; Gary D Foster; Kevin Volpp Journal: Clin Trials Date: 2016-09-23 Impact factor: 2.486
Authors: William S Yancy; Stephanie B Mayer; Cynthia J Coffman; Valerie A Smith; Ronette L Kolotkin; Paula J Geiselman; Megan A McVay; Eugene Z Oddone; Corrine I Voils Journal: Ann Intern Med Date: 2015-06-16 Impact factor: 25.391
Authors: Corrine I Voils; Rachel Adler; Elizabeth Strawbridge; Janet Grubber; Kelli D Allen; Maren K Olsen; Megan A McVay; Sridharan Raghavan; Susan D Raffa; Luke M Funk Journal: Health Psychol Date: 2020-01-30 Impact factor: 4.267