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The Energy Balance Study (EBS)

Oregon Health & Science University (OHSU) logo

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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