Efficacy of Olibra: A 12 Week Controlled Trial

This study has been completed.
Sponsor:
Collaborator:
GNC
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01416051
First received: August 11, 2011
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Overweight
Obesity
Dietary Supplement: Olibra
Other: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of Olibra: A 12 Week Randomized Controlled Trial, and Review of Prior Studies

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Treatment to determine if test product causes weight loss


Secondary Outcome Measures:
  • Body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To determine if treatment causes a reduction in body fat mass

  • Food intake [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    To determine if treatment results in a reduction in food intake


Enrollment: 82
Study Start Date: January 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01416051

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
GNC
  More Information

No publications provided by Pennington Biomedical Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01416051     History of Changes
Other Study ID Numbers: PBRC25001
Study First Received: August 11, 2011
Last Updated: October 30, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014