The Energy Balance Study

Study Overview
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Brief Summary
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Very low carbohydrate diets and high-complex carbohydrate, low-fat diets are popular weight-loss methods in the United States. The purpose of the Energy Balance Study is to explore how extreme differences in diet affect eating behaviors, activity and calorie-use, and body composition. We will conduct a controlled feeding study (all food will be provided for the duration of the study) in which obese adults will be randomly assigned to one of three dietary groups: a low-carbohydrate-eat as much as you like diet, a high-carbohydrate-eat as much as you like diet, or a high-carbohydrate-calorie-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. During the first 3 weeks, participants will eat a typical diet adjusted so that they neither gain or lose weight. Then, for 6 weeks, they will eat their assigned research diet. Resting calorie use and body composition measurements will be taken at the end of week 2 and week 9. Frequent blood sampling for 24 hours will be done through a catheter (tube) placed in an arm vein at the end of weeks 2 and week 9 and for 12 hours at the end of week 3. Change in body composition, activity and energy expenditure, and blood components known to influence eating behavior will be measured under typical diet conditions and after one-day and 6 weeks of the research diet.

Official Title
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Energy and Appetite Regulation by Low CHO Diets

Conditions
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Obesity

Intervention / Treatment
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* Other: Low carbohydrate diet
* Other: High-carbohydrate ad libitum intervention
* Other: High carbohydrate diet-energy matched intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI; 30-50 kg/m2 Age at least 21 years Relative good health Exclusion Criteria: Major debilitating mental or physical illness that would interfere with participation Renal or hepatic disease, diabetes History of gallbladder disease/removal Hyper-or hypothyroidism Poorly controlled hypertension Use of lipid lowering medications Pregnancy or lactation Current excessive use of alcohol Current/recent chronic use of tobacco

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low carbohydrate diet<br>6 week ad libitum low carbohydrate diet; research diet provided at 120% of estimated energy requirement for weight maintenance; carbohydrate intake limited to 28g/d | Other: Low carbohydrate diet<br>* Ad libitum low carbohydrate diet (<28g carbohydrate/day). Participants provided with research diet at 120% of estimated energy needs for weight maintenance and allowed to eat as much or as little of the food desired.<br>* Other names: Atkins Diet;|
| Active Comparator: High Carbohydrate Diet-ad libitum<br>High complex carbohydrate diet (55% carbohydrate, 18% protein, 27% fat. 120% of estimated energy needs for weight maintenance provided, participants allowed to eat as much or as little as desired to satisfy appetite | Other: High-carbohydrate ad libitum intervention<br>* Participants provided with a high complex carbohydrate diet (55% carbohydrate, 18% protein, and 27% fat) at 120% of estimated energy needs for weight maintenance and allowed to eat as much or as little of the foods provided as desired<br>* Other names: DASH-ad lib diet;|
| Active Comparator: High Carbohydrate Diet-Energy-matched<br>High carbohydrate diet (55% carbohydrate, 18% protein and 27% fat). Energy intake restricted to  68% of energy needs for weight maintenance. Participants required to eat all food provided and nothing else | Other: High carbohydrate diet-energy matched intervention<br>* Participants provided a high complex carbohydrate diet (55% carbohydrate, 18% protein, and 27% fat) at  70% of estimated energy needs to maintain weight. Participants required to eat all food provided and nothing else.<br>* Other names: DASH energy-mathched diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weightloss |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight regulation hormones (insulin, leptin, ghrelin, GLP-1, PYY) |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Weight loss, low carbohydrate diets, high complex carbohydrate diets, Healthy adults, Body composition, Energy Expenditure