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NCT00198965 · ClinicalTrials.gov registry record · NA

Olestra Containing Foods and Weight Loss and Weight Maintenance

A NA study, sponsored by Johns Hopkins Bloomberg School of Public Health.

Completed
Registry status
NA
Development phase
257
Enrollment target

NCT00198965 is a NA study that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 257 participants.

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The verdict

NCT00198965, a NA study, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.

COMPLETED
Registry status
NA
Development phase
257 participants
Enrollment target

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.

Interventions

  • BEHAVIORAL dietary education
  • BEHAVIORAL dietary education and provided full fat snack foods
  • BEHAVIORAL dietary education and provided fat free snack foods

Trial Details

FieldValue
Enrollment Target 257 participants
Start Date 1999-03
Est. Completion 2003-12
Phase NA

What the Registry Record Tells You About NCT00198965

The ClinicalTrials.gov registry entry for NCT00198965 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 257 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins Bloomberg School of Public Health, which has 187 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which dietary education is the first listed.

NCT00198965 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00198965 about?

NCT00198965 is a clinical study titled "Olestra Containing Foods and Weight Loss and Weight Maintenance". 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-containi...

What is the current status of trial NCT00198965?

This trial is currently completed. It is a NA study. The enrollment target is 257 participants. The study started on 1999-03. Estimated completion is 2003-12.

What interventions are being tested in trial NCT00198965?

The interventions under investigation include: dietary education (BEHAVIORAL), dietary education and provided full fat snack foods (BEHAVIORAL), dietary education and provided fat free snack foods (BEHAVIORAL).

Who is sponsoring clinical trial NCT00198965?

This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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