NCT00529919

Brief Summary

The primary aim of this research project is to determine whether the incorporation of food products containing medium chain triglyceride (MCT) oil in a weight-loss program results in a different degree of weight-loss and total and regional fat mass loss than the incorporation of extra light olive oil. The secondary goals are to test whether there are differences in in metabolic risk profile changes between the 2 diets. We hypothesize that men and women who consumed MCT oil as part of their weight loss program will lose more weight and body fat than those who consume olive oil in their weight loss diet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2005

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
Last Updated

September 14, 2007

Status Verified

September 1, 2007

First QC Date

September 12, 2007

Last Update Submit

September 12, 2007

Conditions

Keywords

OverweightObesityWeight lossMedium chain triglyceridesCardiovascular disease risk

Outcome Measures

Primary Outcomes (1)

  • Change in body weight and fat mass, change in plasma lipid concentrations, fasting glucose and fasting insulin

    16 weeks

Secondary Outcomes (1)

  • Change in blood pressure, change in fat-free mass

    16 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

MCT oil consumption

Dietary Supplement: Weight loss

2

PLACEBO COMPARATOR

Olive oil consumption

Dietary Supplement: Weight loss

Interventions

Weight lossDIETARY_SUPPLEMENT

Weight loss study including consumption of either 22-25 g of medium chain triglyceride oil or olive oil

Also known as: MCT oil, Neobee 1053, Stepan Company
12

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • body mass index 27-33 kg/m2
  • pre-menopausal women
  • weight stable for at least 6 months
  • normal score on Brief Symptoms Inventory questionnaire

You may not qualify if:

  • chronic disease
  • weight loss treatment
  • medication known to affect body weight
  • unstable blood pressure, glucose, lipid levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • St-Onge MP, Bosarge A, Goree LL, Darnell B. Medium chain triglyceride oil consumption as part of a weight loss diet does not lead to an adverse metabolic profile when compared to olive oil. J Am Coll Nutr. 2008 Oct;27(5):547-52. doi: 10.1080/07315724.2008.10719737.

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Marie-Pierre St-Onge, Ph.D

    St. Luke's-Roosevelt Hospital Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2007

First Posted

September 14, 2007

Study Start

March 1, 2005

Study Completion

June 1, 2007

Last Updated

September 14, 2007

Record last verified: 2007-09

Locations