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NCT00644098 Clinical Trial

Effect of a Soluble Fibre Blend and Medium Chain Triglycerides on Body Composition and Cardiometabolic Risk Factors

People Who Are Overweight or Obesity Clinical Trial

Official title:
The Effect and Dose-response of Soluble Fibre Blend and Medium Chain Triglycerides (MCT) on Body Composition and Cardiometabolic Risk Factors in Overweight and Obese Adults: a Double-blind, Placebo-controlled Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00644098
Other study ID # 002
Secondary ID
Status Completed
Phase Phase 2
First received March 24, 2008
Last updated September 30, 2015
Start date September 2008
Est. completion date August 2009

Study information
Verified date September 2015
Source Canadian Center for Functional Medicine
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether the addition of capsules containing soluble fibre complex emulsified with medium chain triglycerides and taken before with meals will lead to a significant amount of weight loss, reduced glycemic volatility and diminished cardio metabolic risk factors in overweight and obese individuals when compared to a placebo control.

We believe that those participants taking 3-6 capsules per day of the treatment capsules over a 14 week period will loose a significant amount of weight compared to the placebo group.

Recruitment information / eligibility
Status Completed
Enrollment 138
Est. completion date August 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria:

- BMI 27 - 35 kg/m2

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• soluble fibre complex and medium chain triglycerides

• cellulose and soybean oil

Locations
Country Name City State
Canada Canadian Center for Functional Medicine Coquitlam British Columbia

Sponsors (2)
Lead Sponsor Collaborator
Canadian Center for Functional Medicine University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary weight loss baseline, biweekly and final visit No
Secondary glycemic volatility and cardio metabolic risk factors baseline and final visit No

External Links