The Energy Balance Study (EBS)
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|ClinicalTrials.gov Identifier: NCT01029483|
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : December 10, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Other: Low carbohydrate diet Other: High-carbohydrate ad libitum intervention Other: High carbohydrate diet-energy matched intervention||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Energy and Appetite Regulation by Low CHO Diets|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
Experimental: Low carbohydrate diet
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
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.
Active Comparator: High Carbohydrate Diet-ad libitum
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
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
Active Comparator: High Carbohydrate Diet-Energy-matched
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
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.
- weightloss [ Time Frame: 6 weeks ]
- weight regulation hormones (insulin, leptin, ghrelin, GLP-1, PYY) [ Time Frame: 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029483
|Principal Investigator:||Diane D Stadler, PhD||Oregon Health and Science University|