The Energy Balance Study (EBS)

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Other: High-carbohydrate ad libitum intervention; Other: Low carbohydrate diet; Other: High carbohydrate diet-energy matched intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01029483

R21AT002753

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 3 patient groups

Low carbohydrate diet

Experimental group

Description:

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

Treatment:

Other: Low carbohydrate diet

High Carbohydrate Diet-ad libitum

Active Comparator group

Description:

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

Treatment:

Other: High-carbohydrate ad libitum intervention

High Carbohydrate Diet-Energy-matched

Active Comparator group

Description:

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

Treatment:

Other: High carbohydrate diet-energy matched intervention