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Completed

NCT Number: NCT00619008

Energy Balance Weight Regulation Study

The purpose of this study is to test the hypothesis that a low-carbohydrate diet will impact hormones and other factors that regulate appetite and energy balance, and result in lower energy intake and greater weight loss, than a high complex carbohydrate diet.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oregon Health & Science University

Portland, Oregon, 97229, United States

About this study

The rising epidemic of obesity in the United States is accompanied by widespread public use of low carbohydrate diets for weight loss. The popularity of these diets is due partly to the promise of a "metabolic advantage" that promotes faster weight loss without an overriding sense of hunger. If this claim is true, we hypothesize that a low-carbohydrate diet will impact hormones and other factors that regulate appetite and energy balance, and result in lower energy intake and greater weight loss, than a high complex carbohydrate diet. To test this hypothesis, we will conduct a randomized, controlled feeding trial in which obese adults will be randomly assigned to one of three interventions: a low-carbohydrate-ad libitum diet, a high-carbohydrate-ad libitum diet, or a high-carbohydrate-energy-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. Participants will eat a standardized weight maintenance diet for 3 weeks. Then, for 6-weeks, participants assigned to either ad libitum group will be given their assigned diet at 120% of there estimated energy needs to maintain weight and allowed to eat as much as desired. Participants assigned to the energy-restricted group will be provided a DASH diet at 67% of their estimated energy needs to maintain weight and asked to eat all foods provided. Food intake will be measured daily. Body weight and hunger and satiety scores will be measured three times a week. Body composition and energy expenditure will be measured before and after the intervention. 24-hour profiles of hormones and other factors that influence central appetite and weight regulation (insulin, leptin, ghrelin, PYY, GLP-1) will be measured before, and on first and last days of the intervention, to compare acute and chronic metabolic effects of the diets. The analysis of primary outcomes will be based on repeated measures and longitudinal models methodology. This study offers a unique opportunity to explore how extreme differences in dietary composition, before and after weight loss, affect components of energy balance and markers of central appetite and weight regulation. These results will be used to design hypothesis-driven studies of the identified mediators of appetite and weight regulation in response to dietary manipulation.

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 21-65 years
  • Relative good health

Exclusion criteria

  • Major debilitating mental of physical illness that would interfere with participation
  • Renal or hepatic disease, diabetes, gallbladder disease, untreated hyper-or hypothyroidism, poorly controlled hypertension (>3 HT medications)
  • Use of lipid lowering medications
  • Current of recent (within 12 mo) pregnancy or lactation
  • Current excessive use of alcohol
  • Current/recent (within 1 year)use of tobacco products
  • Food allergies, food restrictions, or food preferences that are inconsistent with the research diets

Treatment and study plan

Ad libitum low carbohydrate diet

Other

6 week ad libitum low carbohydrate diet

Other names: Low Carb diet

Ad libitum High Complex Carbohydrate Diet

Other

6 week ad libitum high complex carbohydrate diet

Other names: DASH diet

Energy-restricted high complex carbohydrate diet

Other

6 week energy-restricted (68% of estimated energy requirement for weight maintenance) high complex carbohydrate diet.

Other names: Energy-restricted DASH diet

Primary outcomes

  1. 24-hour profiles and AUCs of hormones and other factors that influence central appetite and weight regulation (insulin, leptin, ghrelin, PYY, GLP-1).

    Time frame: Week 2, week 3 and week 9 of intervention

Secondary outcomes

  1. Energy intake, hunger and satiety ratings

    Time frame: week 2, 3, and 9 of intervention

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Nih

Registry information

Official study title

Energy and Appetite Regulation by High and Low CHO Diets

Acronym: BALANCE

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Feb 20, 2008
Registry last updated
Oct 3, 2008

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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