Nutritional Restriction and Activity Thermogenesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2007-11-30

Brief Summary

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These studies will provide us with enormous insight regarding how obese patients adapt energetically during negative energy balance. We will gain fundamental information regarding the metabolic implications of combining food restriction with a walking program compatible to that advocated by statutory agencies. These studies will lead to improved understanding of the energetic adaptation that occurs during negative energy balance and how best to treat patients with obesity.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Exercise and behavior modification

Participants will undergo 1000 kcal/day caloric restriction (relative to experimentally determined weight-maintenance caloric needs) for 8 weeks during one phase of study. Additional 11 week period consists of 8 weeks of caloric restriction with an additional daily walking program.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

(A) LEAN: 30 (15F,15M) lean subjects; BMI \<25 kg/m2. Each lean subject will be individually matched for height (+3cm) and age (+3 years) to an obese subject so as to establish comparable groupings for body size. Subjects will have been weight-stable for six months (B) OBESE: 30 (15F,15M) obese subjects; BMI 30-35 kg/m2. Subjects will have been weight-stable for six months (C) POST-OBESE: 30 (15F,15M) patients will have had a previous BMI \>30 kg/m2 and a weight loss sufficient to achieve a BMI of \<26 kg/m2 maintained for at least 2 months (with weight fluctuation during this period of \<1 kg) (94). We will attempt to match these subjects to the obese subjects as described above.

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes