Olestra Containing Foods and Weight Loss and Weight Maintenance
Completed · Not applicable
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT00198965
- Run by
- Johns Hopkins Bloomberg School of Public Health
- People needed
- 257
- Starts
- 1999-03-01
- Expected to finish
- 2003-12-01
- Last updated by the study team
- 2005-09-20
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- male and female, between 25 and 50 years of age, interested in losing weight, body mass index between 30 and 33, informed consent
You may not qualify if…
- unwilling to eat study provided foods
Where it is running
- Johns Hopkins University — Lutherville, Maryland, United States
Full record on ClinicalTrials.gov
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