Olestra Containing Foods and Weight Loss and Weight Maintenance
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dietary education
dietary education and provided full fat snack foods
dietary education and provided fat free snack foods
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria: male and female, between 25 and 50 years of age, interested in losing weight, body mass index between 30 and 33, informed consent Exclusion Criteria: unwilling to eat study provided foods
Sites / Locations
- Johns Hopkins University
Outcomes
Primary Outcome Measures
weight
blood values
body composition
Secondary Outcome Measures
waist/hip measurements
psychometrics
blood pressure
pulse
Full Information
NCT ID
NCT00198965
First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Procter and Gamble
1. Study Identification
Unique Protocol Identification Number
NCT00198965
Brief Title
Olestra Containing Foods and Weight Loss and Weight Maintenance
Official Title
Benefits of Sensory-Enhanced Products in Weight Loss and Maintenance
Study Type
Interventional
2. Study Status
Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Procter and Gamble
4. Oversight
5. Study Description
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.
Detailed Description
During Phase I, the three groups will attend mandatory, 1 hour, bi-weekly group meetings. Participants will keep food records for 2 weekdays and 1 weekend day during each 2 week period as well as keeping exercise, snack and sleep logs daily. At each meeting, research staff will collect the completed food records and logs and new forms will be distributed. At weeks 8 and 16 of active weight loss, participants will repeat the assessments (blood tests, body composition, and questionnaires) conducted at baseline to determine treatment-induced changes in each of the dependent measures.
During phase II, all of the groups will participate in group meetings held 1 month after beginning maintenance and quarterly over 52 weeks. Dependent upon group, participants will pick-up foods bi-weekly and body weight will be assessed every 4 weeks. The full battery of assessments will be conducted at 26 weeks and at the end of the maintenance phase at 52 weeks.
Participants will be 180 adults (male and female) between 25 and 50 years of age. The study is designed to answer questions involving an adult population. Participants must be interested in losing weight. Participants must have a body mass index between 30 and 33 because this study is designed to answer questions investigating overweight individuals that are not morbidly obese. Participants with preliminary eligibility, determined via phone screening, will be invited to the clinic for a more in-depth screening including demographic and medical history questionnaires and psychosocial measures. Participants will gibe their consent to provide this information via completing a screening consent form (a separate form from the study consent form). Once this secondary eligibility is determined, a study consent form will be completed, and participants will undergo a baseline screening of physical measures, blood tests (CBC, SMA-20), body composition assessment (via bioelectrical impedance), and complete additional psychosocial questionnaires. Any participants found to be ineligible as a result of these measures will not be permitted to continue in the study, but will be referred for medical care if appropriate. Participants deemed eligible will proceed to the weight loss phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
257 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
dietary education
Intervention Type
Behavioral
Intervention Name(s)
dietary education and provided full fat snack foods
Intervention Type
Behavioral
Intervention Name(s)
dietary education and provided fat free snack foods
Primary Outcome Measure Information:
Title
weight
Title
blood values
Title
body composition
Secondary Outcome Measure Information:
Title
waist/hip measurements
Title
psychometrics
Title
blood pressure
Title
pulse
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
male and female, between 25 and 50 years of age, interested in losing weight, body mass index between 30 and 33, informed consent
Exclusion Criteria:
unwilling to eat study provided foods
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence J Cheskin, MD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Olestra Containing Foods and Weight Loss and Weight Maintenance
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