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Efficacy of Olibra: A 12 Week Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01416051
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : December 18, 2015
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

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
Overweight Obesity 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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

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 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

Primary Outcome Measures :
  1. Body weight [ Time Frame: 12 weeks ]
    Treatment to determine if test product causes weight loss

Secondary Outcome Measures :
  1. Body composition [ Time Frame: 12 weeks ]
    To determine if treatment causes a reduction in body fat mass

  2. Food intake [ Time Frame: 4 weeks ]
    To determine if treatment results in a reduction in food intake

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01416051

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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center Identifier: NCT01416051    
Other Study ID Numbers: PBRC 25001
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Body Weight