Energy Balance Weight Regulation Study

NCT00619008 | Completed Phase 2 DMC

• 1 other identifier: R21AT002753
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

obesity; low carbohydrate diet; high complex carbohydrate diet; weight regulation hormones; hunger; satiety; energy expenditure; body composition; weight loss

Outcome Measures

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).

  Week 2, week 3 and week 9 of intervention

Secondary Outcomes (1)

• Energy intake, hunger and satiety ratings

  week 2, 3, and 9 of intervention

Study Arms (3)

1

EXPERIMENTAL

Ad libitum low carbohydrate diet

Other: Ad libitum low carbohydrate diet

2

EXPERIMENTAL

Ad libitum high complex carbohydrate diet

Other: Ad libitum High Complex Carbohydrate Diet

3

EXPERIMENTAL

Energy-restricted high complex carbohydrate diet

Other: Energy-restricted high complex carbohydrate diet

Interventions

Ad libitum low carbohydrate diet OTHER

6 week ad libitum low carbohydrate diet

Also known as: Low Carb diet

1

Ad libitum High Complex Carbohydrate Diet OTHER

6 week ad libitum high complex carbohydrate diet

Also known as: DASH diet

2

Energy-restricted high complex carbohydrate diet OTHER

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

Also known as: Energy-restricted DASH diet

3

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 21-65 years
• Relative good health

You may not qualify if:

• 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

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97229, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Dietary Approaches To Stop Hypertension

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

Study Officials

• Diane D Stadler, PhD

  OSHU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 15, 2008
• First Posted: February 20, 2008
• Study Start: April 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 3, 2008

Record last verified: 2008-10

Locations

US (1)