Weight Loss Clinical Trial
Official title:
A Randomized, Double Blind, Placebo Controlled Trial Evaluating the Effects of a High Viscosity Dietary Fibre (PGX) Supplementation of a Low Calorie Diet on Appetite and Body Weight, in Overweight and Moderately Obese Females
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 |
This 18 week, randomized, double blind, placebo controlled trial will examine the effects of
thick dietary fibre (PGX) supplementation of a low calorie diet (LCD) on appetite, weight
loss, body composition, and compliance in overweight and moderately obese female.
The investigators believe that 15 grams/day PGX supplementation of a low calorie diet over a
14-weeks period will elicit a better appetite score (e.g. reduced hunger) compared to the
rice flour supplementation of the LCD.
Status | Completed |
Enrollment | 20 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 55 Years |
Eligibility |
Inclusion Criteria: - BMI 25 - 35 Kg/m2 Exclusion Criteria: - Medications and supplements that affect appetite - Known diabetes - Contraindications to LCD - Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Canadian Center for Functional Medicine | Coquitlam | British Columbia |
Canada | Canadian Center for Functional Medicine | Coquitlam | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Canadian Center for Functional Medicine | InovoBiologic Inc., University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The difference in appetite score assessed from appetite Visual Analog Scale | 18 weeks | No | |
Secondary | Change in weight (kilograms) | 18 weeks | No | |
Secondary | Change in percentage of body fat | 18 weeks | No |
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