Effects of a Dietary Fibre Supplementation of a Low Calorie Diet on Appetite and Body Weight
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
1 other identifier
interventional
20
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2010
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2010
CompletedFirst Posted
Study publicly available on registry
April 23, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedOctober 2, 2015
September 1, 2015
8 months
April 20, 2010
September 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The difference in appetite score assessed from appetite Visual Analog Scale
18 weeks
Secondary Outcomes (2)
Change in weight (kilograms)
18 weeks
Change in percentage of body fat
18 weeks
Study Arms (2)
PolyGlycopleX (PGX)
EXPERIMENTALRice Flour
PLACEBO COMPARATORInterventions
The full dose of the study intervention is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.
The full dose of the placebo comparator is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.
Eligibility Criteria
You may qualify if:
- BMI 25 - 35 Kg/m2
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Canadian Center for Functional Medicinelead
- University of British Columbiacollaborator
- InovoBiologic Inc.collaborator
Study Sites (2)
Canadian Center for Functional Medicine
Coquitlam, British Columbia, V3K 6Y7, Canada
Canadian Center for Functional Medicine
Coquitlam, British Columbia, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael R Lyon, M.D.
Canadian Center for Functional Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2010
First Posted
April 23, 2010
Study Start
August 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
October 2, 2015
Record last verified: 2015-09