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Olestra Containing Foods and Weight Loss and Weight Maintenance

NCT00198965 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2005-09-20

No results posted yet for this study

Summary

This study will be conducted over three phases. Phase I will be a 16-week weight lass phase. Phase II will be a 52-week maintenance phase. Phase III will be a follow-up phase. We will test three diet regimens: 1) an olestra group who will receive a weight-reducing diet that includes olestra-containing products; 2) a triglyceride group who will receive the same weight-reducing diet but with foods made with triglyceride (regular fat); 3) a low-fat group will be instructed to consume a diet made of traditionally low-fat foods that ate available in grocery stores (no olestra foods). These groups will be re-randomized for the maintenance phase and again assigned to one of the three weight loss regimens described above: olestra, triglyceride, or low-fat. In the double-blinded experimental design, groups receiving olestra foods will not be informed of the nutrient contents of the foods or told what fat substitute is used in the preparation. (The consent form will state that a new fat-substitute may be used in the study foods.) During a "run-in" phase, olestra versus regular-fat food sensory and tolerance tests will be conducted.

Conditions

Interventions

BEHAVIORAL

dietary education

BEHAVIORAL

dietary education and provided full fat snack foods

BEHAVIORAL

dietary education and provided fat free snack foods

Sponsors & Collaborators

  • Procter and Gamble

    collaborator INDUSTRY

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Lawrence J Cheskin, MD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-03-31
Completion
2003-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00198965 on ClinicalTrials.gov