The Energy Balance Study

NCT01029483 | Completed Phase 1 DMC

• 1 other identifier: R21AT002753
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity

Keywords

Obesity; Weight loss; low carbohydrate diets; high complex carbohydrate diets; Healthy adults; Body composition; Energy Expenditure

Outcome Measures

Primary Outcomes (1)

• weightloss

  6 weeks

Secondary Outcomes (1)

• weight regulation hormones (insulin, leptin, ghrelin, GLP-1, PYY)

  6 weeks

Study Arms (3)

Low carbohydrate diet

EXPERIMENTAL

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

High Carbohydrate Diet-ad libitum

ACTIVE COMPARATOR

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

High Carbohydrate Diet-Energy-matched

ACTIVE COMPARATOR

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

Interventions

Low carbohydrate diet OTHER

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.

Also known as: Low CHO diet, Atkins Diet

Low carbohydrate diet

High-carbohydrate ad libitum intervention OTHER

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

Also known as: High CHO-ad lib diet, DASH-ad lib diet

High Carbohydrate Diet-ad libitum

High carbohydrate diet-energy matched intervention OTHER

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.

Also known as: High CHO energy-matched diet, DASH energy-mathched diet

High Carbohydrate Diet-Energy-matched

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI; 30-50 kg/m2
• Age at least 21 years
• Relative good health

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Kaiser Permanente: collaborator

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Diet, Carbohydrate-Restricted; Diet, High-Protein Low-Carbohydrate

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet, High-Protein

Study Officials

• Diane D Stadler, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 10, 2009
• Study Start: September 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 10, 2009

Record last verified: 2009-12