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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00619008 |
The purpose of this study is to test the hypothesis that a low-carbohydrate diet will impact hormones and other factors that regulate appetite and energy balance, and result in lower energy intake and greater weight loss, than a high complex carbohydrate diet.
Condition | Intervention | Phase |
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Obesity |
Other: Ad libitum low carbohydrate diet Other: Ad libitum High Complex Carbohydrate Diet Other: Energy-restricted high complex carbohydrate diet |
Phase II |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Bio-equivalence Study |
Official Title: | Energy and Appetite Regulation by High and Low CHO Diets |
Enrollment: | 35 |
Study Start Date: | April 2005 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Ad libitum low carbohydrate diet
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Other: Ad libitum low carbohydrate diet
6 week ad libitum low carbohydrate diet
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2: Experimental
Ad libitum high complex carbohydrate diet
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Other: Ad libitum High Complex Carbohydrate Diet
6 week ad libitum high complex carbohydrate diet
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3: Experimental
Energy-restricted high complex carbohydrate diet
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Other: Energy-restricted high complex carbohydrate diet
6 week energy-restricted (68% of estimated energy requirement for weight maintenance) high complex carbohydrate diet.
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The rising epidemic of obesity in the United States is accompanied by widespread public use of low carbohydrate diets for weight loss. The popularity of these diets is due partly to the promise of a "metabolic advantage" that promotes faster weight loss without an overriding sense of hunger. If this claim is true, we hypothesize that a low-carbohydrate diet will impact hormones and other factors that regulate appetite and energy balance, and result in lower energy intake and greater weight loss, than a high complex carbohydrate diet. To test this hypothesis, we will conduct a randomized, controlled feeding trial in which obese adults will be randomly assigned to one of three interventions: a low-carbohydrate-ad libitum diet, a high-carbohydrate-ad libitum diet, or a high-carbohydrate-energy-restricted diet. The low-carbohydrate diet will be modeled after the Induction Phase of the Atkins Diet. The high carbohydrate diet will be based on the "Dietary Approaches to Stop Hypertension (DASH)" diet. Participants will eat a standardized weight maintenance diet for 3 weeks. Then, for 6-weeks, participants assigned to either ad libitum group will be given their assigned diet at 120% of there estimated energy needs to maintain weight and allowed to eat as much as desired. Participants assigned to the energy-restricted group will be provided a DASH diet at 67% of their estimated energy needs to maintain weight and asked to eat all foods provided. Food intake will be measured daily. Body weight and hunger and satiety scores will be measured three times a week. Body composition and energy expenditure will be measured before and after the intervention. 24-hour profiles of hormones and other factors that influence central appetite and weight regulation (insulin, leptin, ghrelin, PYY, GLP-1) will be measured before, and on first and last days of the intervention, to compare acute and chronic metabolic effects of the diets. The analysis of primary outcomes will be based on repeated measures and longitudinal models methodology. This study offers a unique opportunity to explore how extreme differences in dietary composition, before and after weight loss, affect components of energy balance and markers of central appetite and weight regulation. These results will be used to design hypothesis-driven studies of the identified mediators of appetite and weight regulation in response to dietary manipulation.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Oregon Health & Science University ( Diane D. Stadler ) |
Study ID Numbers: | R21 AT002753 |
Study First Received: | February 15, 2008 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00619008 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Federal Government |
obesity low carbohydrate diet high complex carbohydrate diet weight regulation hormones hunger |
satiety energy expenditure body composition weight loss |
Body Weight Signs and Symptoms Obesity Weight Loss |
Nutrition Disorders Overweight Overnutrition Hormones |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |