The Energy Balance Study (EBS)

Energy and Appetite Regulation by Low CHO Diets

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Low carbohydrate diet; Other: High-carbohydrate ad libitum intervention; Other: High carbohydrate diet-energy matched intervention

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other Names: Low CHO diet; Atkins Diet
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; Other Names: High CHO-ad lib diet; DASH-ad lib diet
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.; Other Names: High CHO energy-matched diet; DASH energy-mathched diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
weightloss	6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Kaiser Permanente
• Investigators: Principal Investigator: Diane D Stadler, PhD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (ACTUAL): June 1, 2009
• Study Completion (ACTUAL): June 1, 2009

Study Registration Dates

• First Submitted: December 9, 2009
• First Submitted That Met QC Criteria: December 9, 2009
• First Posted (ESTIMATE): December 10, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): December 10, 2009
• Last Update Submitted That Met QC Criteria: December 9, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Obesity; Weight loss; Body composition; Energy Expenditure; Healthy adults; low carbohydrate diets; high complex carbohydrate diets
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: R21AT002753 (NIH)