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Efficacy of Olibra: A 12 Week Controlled Trial

NCT ID: NCT01416051

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Olibra

Intervention Type DIETARY_SUPPLEMENT

Fractionated palm oil and fractionated oat oil in the proportion of 95:5

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

100% milk fat

Interventions

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Olibra

Fractionated palm oil and fractionated oat oil in the proportion of 95:5

Intervention Type DIETARY_SUPPLEMENT

Placebo

100% milk fat

Intervention Type OTHER

Other Intervention Names

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Fabuless

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GNC

UNKNOWN

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Frank Greenway

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

References

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Rebello CJ, Martin CK, Johnson WD, O'Neil CE, Greenway FL. Efficacy of Olibra: a 12-week randomized controlled trial and a review of earlier studies. J Diabetes Sci Technol. 2012 May 1;6(3):695-708. doi: 10.1177/193229681200600326.

Reference Type DERIVED
PMID: 22768902 (View on PubMed)

Other Identifiers

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PBRC 25001

Identifier Type: -

Identifier Source: org_study_id