NCT01416051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2011

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

1.8 years

First QC Date

August 11, 2011

Last Update Submit

December 17, 2015

Conditions

OverweightObesity

Outcome Measures

Primary Outcomes (1)

  • Body weight

    Treatment to determine if test product causes weight loss

    12 weeks

Secondary Outcomes (2)

  • Body composition

    12 weeks

  • Food intake

    4 weeks

Study Arms (2)

Test

ACTIVE COMPARATOR

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

Control Group

PLACEBO COMPARATOR

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

Interventions

OlibraDIETARY_SUPPLEMENT

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

Also known as: Fabuless
Test
PlaceboOTHER

100% milk fat

Control Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects of both sexes 18 - 60 years of age
  • body mass index (BMI) between 25 and 40 kg/m2, inclusive

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • 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.

    PMID: 22768902DERIVED

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2011

First Posted

August 12, 2011

Study Start

January 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations

US(1)