Effects of Medium Chain Triglyceride Oil, Versus Olive Oi... | NCT00529919

Studies
Effects of Medium Chain Triglyceride Oil, Versus Olive Oil, for Weight Loss

NCT00529919

Sponsor

University of Alabama at Birmingham

Status

Completed

Last Update Posted

Sep 14, 2007Estimated

Enrollment

53Actual

Phase

Not Applicable

Conditions

Overweight

Interventions

Weight loss

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Not provided

Completion Date

Jun 2007Actual

First Submitted Date

Sep 12, 2007

First Submission Date that Met QC Criteria

Sep 12, 2007

First Posted Date

Sep 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2007

Last Update Posted Date

Sep 14, 2007Estimated

Name	Class
International Life Sciences Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	MCT oil consumption	Dietary Supplement: Weight loss
2	Placebo Comparator	Olive oil consumption	Dietary Supplement: Weight loss

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Weight loss	Dietary Supplement	Weight loss study including consumption of either 22-25 g of medium chain triglyceride oil or olive oil	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in body weight and fat mass, change in plasma lipid concentrations, fasting glucose and fasting insulin		16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in blood pressure, change in fat-free mass		16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie-Pierre St-Onge, Ph.D	St. Luke's-Roosevelt Hospital Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18845704	Derived	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.

ID	Term
D050177	Overweight
D009765	Obesity
D015431	Weight Loss

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight