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Completed

NCT Number: NCT01029483

The Energy Balance Study

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Low CHO diet, Atkins 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

Other names: High CHO-ad lib diet, DASH-ad lib diet

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.

Other names: High CHO energy-matched diet, DASH energy-mathched diet

Primary outcomes

  1. weightloss

    Time frame: 6 weeks

Secondary outcomes

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

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Kaiser Permanente

Registry information

Official study title

Energy and Appetite Regulation by Low CHO Diets

Acronym: EBS

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Dec 10, 2009
Registry last updated
Dec 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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