Clincosm LogoSign in Get a demo

Efficacy of Olibra: A 12 Week Controlled Trial

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT01416051
Collaborator
GNC (Other)
82
Enrollment
1
Location
2
Arms
22
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Today's obesogenic environment, favors behavioral choices that lead to an excess of energy intake over expenditure, and consequently weight gain. Intervention strategies that harness the body's own appetite and satiety regulating signals could provide an effective means of countering excessive energy intake. The purpose of this study was to investigate whether a vegetable oil emulsion (Olibra) would result in weight loss that was associated with a reduction in food intake.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Olibra
  • Other: Placebo
 Phase 1/Phase 2

Detailed Description

71 healthy subjects were enrolled (60 females, 11 males; Age: 18 - 60 years, BMI 25 - 40 kg/m2) in a two-phased, randomized, placebo-controlled, double-blind, parallel trial. During a 12-week period, Olibra was compared with a placebo (milk fat). Food intake testing was conducted on three days and anthropometric data was collected on 7 days. Key outcome measures were, body weight, body composition, energy intake, and appetite ratings.

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Efficacy of Olibra: A 12 Week Randomized Controlled Trial, and Review of Prior Studies
Study Start Date :
Jan 1, 2005
Actual Primary Completion Date :
Nov 1, 2006
Actual Study Completion Date :
Nov 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Test

Subjects consumed a vegetable oil emulsion in yogurt at a food intake test and were asked to consume the product twice daily for 12 weeks.

Dietary Supplement: Olibra
Fractionated palm oil and fractionated oat oil in the proportion of 95:5
Other Names:
  • Fabuless

    		•
    Placebo Comparator: Control Group

    Subjects were given a placebo of milk fat in yogurt at food intake tests and asked to consume the placebo twice daily for 12 weeks.

    Other: Placebo
    100% milk fat

    Outcome Measures

    Primary Outcome Measures

    1. Body weight [12 weeks]

      Treatment to determine if test product causes weight loss

    Secondary Outcome Measures

    1. Body composition [12 weeks]

      To determine if treatment causes a reduction in body fat mass

    2. Food intake [4 weeks]

      To determine if treatment results in a reduction in food intake

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy subjects of both sexes 18 - 60 years of age

    • body mass index (BMI) between 25 and 40 kg/m2, inclusive

    Exclusion Criteria:

    • (1) participation in another clinical trial or receipt of an investigational product 30 days prior to enrollment

    • (2) a dietary restraint score of > 13

    • (3) weight loss of 4.5 kg or more in the preceding three months

    • (4) use of tobacco products, nicotine gum or nicotine patch

    • (5) a medical condition or taking regular medication except oral contraceptives and hormone replacement therapy

    • (6) use of a nutritional product or dietary supplement or program which might interfere with the conduct of the study or place the subject at risk

    • (7) history of alcohol or other drug abuse in the preceding one year

    • (8) pregnancy, lactation, post-partum less than six months, planning a pregnancy during the study or not using an acceptable method of contraception

    • (9) fasting blood sugar ≥ 126 mg/dl

    • (10) known allergy or sensitivity to any ingredient in the supplement

    • (11) clinically significant deviations in normal laboratory values

    • (12) irregular meal-times, and

    • (13) unwilling to eat yogurt at test meals.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808

    Sponsors and Collaborators

    • Pennington Biomedical Research Center
    • GNC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
    ClinicalTrials.gov Identifier:
    NCT01416051
    Other Study ID Numbers:
    • PBRC 25001
    First Posted:
    Aug 12, 2011
    Last Update Posted:
    Dec 18, 2015
    Last Verified:
    Dec 1, 2015
    Additional relevant MeSH terms:
    Overweight

    Study Results

    No Results Posted as of Dec 18, 2015