Olestra Containing Foods and Weight Loss and Weight Maintenance

NCT00198965 | Completed

• 1 other identifier: PG1999-01
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

Brief 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

Obesity

Outcome Measures

Primary Outcomes (3)

• weight

• blood values

• body composition

Secondary Outcomes (4)

• waist/hip measurements

• psychometrics

• blood pressure

• pulse

Interventions

dietary education BEHAVIORAL

dietary education and provided full fat snack foods BEHAVIORAL

dietary education and provided fat free snack foods BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Procter and Gamble: collaborator

Study Sites (1)

Johns Hopkins University

Lutherville, Maryland, 21093, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Lawrence J Cheskin, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: March 1, 1999
• Study Completion: December 1, 2003
• Last Updated: September 20, 2005

Record last verified: 2004-04

Locations

US (1)