The Energy Balance Study (EBS)

This study has been completed.
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01029483
First received: December 9, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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 Intervention Phase
Obesity
Other: Low carbohydrate diet
Other: High-carbohydrate ad libitum intervention
Other: High carbohydrate diet-energy matched intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Energy and Appetite Regulation by Low CHO Diets

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • weightloss [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • weight regulation hormones (insulin, leptin, ghrelin, GLP-1, PYY) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: September 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029483

Sponsors and Collaborators
Oregon Health and Science University
Kaiser Permanente
Investigators
Principal Investigator: Diane D Stadler, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Diane D. Stadler, OHSU
ClinicalTrials.gov Identifier: NCT01029483     History of Changes
Other Study ID Numbers: R21 AT002753
Study First Received: December 9, 2009
Last Updated: December 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Obesity
Weight loss
low carbohydrate diets
high complex carbohydrate diets
Healthy adults
Body composition
Energy Expenditure

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014