Efficacy of Olibra: A 12 Week Controlled Trial

Obesity Clinical Trial

Official title:

Efficacy of Olibra: A 12 Week Randomized Controlled Trial, and Review of Prior Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416051
• Other study ID #: PBRC 25001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 11, 2011
• Last updated: December 17, 2015
• Start date: January 2005
• Est. completion date: November 2006

Study information

• Verified date: December 2015
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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

Other:
• Placebo
100% milk fat

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	GNC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Treatment to determine if test product causes weight loss	12 weeks	Yes
Secondary	Body composition	To determine if treatment causes a reduction in body fat mass	12 weeks	Yes
Secondary	Food intake	To determine if treatment results in a reduction in food intake	4 weeks	Yes