Back to resultsEffect of a Soluble Fibre Blend and Medium Chain Triglycerides on Body Composition and Cardiometabolic Risk Factors
Primary Purpose
People Who Are Overweight or Obesity
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
soluble fibre complex and medium chain triglycerides
cellulose and soybean oil
Sponsored by
About this trial
This is an interventional treatment trial for People Who Are Overweight or Obesity
Eligibility Criteria
Inclusion Criteria:
- BMI 27 - 35 kg/m2
Exclusion Criteria:
-
Sites / Locations
- Canadian Center for Functional Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Intervention
Arm Description
cellulose and soybean oil
soluble fibre complex and medium chain triglycerides
Outcomes
Primary Outcome Measures
weight loss
Secondary Outcome Measures
glycemic volatility and cardio metabolic risk factors
Full Information
NCT ID
NCT00644098
First Posted
March 24, 2008
Last Updated
September 30, 2015
Sponsor
Canadian Center for Functional Medicine
Collaborators
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00644098
Brief Title
Effect of a Soluble Fibre Blend and Medium Chain Triglycerides on Body Composition and Cardiometabolic Risk Factors
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canadian Center for Functional Medicine
Collaborators
University of British Columbia
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
People Who Are Overweight or Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
cellulose and soybean oil
Arm Title
Intervention
Arm Type
Experimental
Arm Description
soluble fibre complex and medium chain triglycerides
Intervention Type
Dietary Supplement
Intervention Name(s)
soluble fibre complex and medium chain triglycerides
Intervention Type
Dietary Supplement
Intervention Name(s)
cellulose and soybean oil
Primary Outcome Measure Information:
Title
weight loss
Time Frame
baseline, biweekly and final visit
Secondary Outcome Measure Information:
Title
glycemic volatility and cardio metabolic risk factors
Time Frame
baseline and final visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI 27 - 35 kg/m2
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Durance, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canadian Center for Functional Medicine
City
Coquitlam
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Effect of a Soluble Fibre Blend and Medium Chain Triglycerides on Body Composition and Cardiometabolic Risk Factors
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