Energy Balance Weight Regulation Study (BALANCE)

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00619008
First received: February 15, 2008
Last updated: October 2, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Obesity
Other: Ad libitum low carbohydrate diet
Other: Ad libitum High Complex Carbohydrate Diet
Other: Energy-restricted high complex carbohydrate diet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Energy and Appetite Regulation by High and Low CHO Diets

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Energy intake, hunger and satiety ratings [ Time Frame: week 2, 3, and 9 of intervention ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: April 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ad libitum low carbohydrate diet
Other: Ad libitum low carbohydrate diet
6 week ad libitum low carbohydrate diet
Other Name: Low Carb diet
Experimental: 2
Ad libitum high complex carbohydrate diet
Other: Ad libitum High Complex Carbohydrate Diet
6 week ad libitum high complex carbohydrate diet
Other Name: DASH diet
Experimental: 3
Energy-restricted high complex carbohydrate diet
Other: Energy-restricted high complex carbohydrate diet
6 week energy-restricted (68% of estimated energy requirement for weight maintenance) high complex carbohydrate diet.
Other Name: Energy-restricted DASH diet

Detailed Description:

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.

  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 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
  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: NCT00619008

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97229
Sponsors and Collaborators
Investigators
Principal Investigator: Diane D Stadler, PhD OSHU
  More Information

No publications provided

Responsible Party: Diane D. Stadler, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00619008     History of Changes
Other Study ID Numbers: R21 AT002753
Study First Received: February 15, 2008
Last Updated: October 2, 2008
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
obesity
low carbohydrate diet
high complex carbohydrate diet
weight regulation hormones
hunger
satiety
energy expenditure
body composition
weight loss

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

ClinicalTrials.gov processed this record on October 19, 2014