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

This study has been completed.
Sponsor:
Collaborator:
University of British Columbia
Information provided by:
Canadian Center for Functional Medicine
ClinicalTrials.gov Identifier:
NCT00644098
First received: March 24, 2008
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
People Who Are Overweight or Obesity
 Dietary Supplement: soluble fibre complex and medium chain triglycerides
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Canadian Center for Functional Medicine:

Primary Outcome Measures:
  • weight loss [ Time Frame: baseline, biweekly and final visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • glycemic volatility and cardio metabolic risk factors [ Time Frame: baseline and final visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2008
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI 27 - 35 kg/m2

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644098

Locations
Canada, British Columbia
Canadian Center for Functional Medicine
Coquitlam, British Columbia, Canada
Sponsors and Collaborators
Canadian Center for Functional Medicine
University of British Columbia
Investigators
Principal Investigator: Timothy Durance, PhD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Michael Lyon, Canadian Center for Functional Medicine
ClinicalTrials.gov Identifier: NCT00644098     History of Changes
Other Study ID Numbers: 002
Study First Received: March 24, 2008
Last Updated: June 21, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013