Evaluation of Subjective Ratings of Appetite and Glucoregulation of a Low Calorie Diet Supplemented With a High Viscosity Polysaccharide (PolyGlycopleX - PGX)
This study has been completed.
Sponsor:
Canadian Center for Functional Medicine
Collaborators:
University of British Columbia
InovoBiologic Inc.
Information provided by:
Canadian Center for Functional Medicine
ClinicalTrials.gov Identifier:
NCT01108328
First received: April 20, 2010
Last updated: November 30, 2010
Last verified: November 2010
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Purpose
The objective of the study is to compare subjective appetite ratings and after-meal and 24 hour blood glucose levels within overweight and obese female subjects consuming either a standardized 3 day low calorie diet supplemented with a viscous fibre known as PGX (treatment) or a rice flour (placebo control). Each treatment phase will be 3 days in length and separated by 3 week washout phase, so subjects will also be acting as their own control. Subjects will be randomized to either start with the low calorie diet with PGX or the low calorie diet supplemented with rice flour. We hypothesize that the 3 day LCD with PGX will elicit an improved appetite score compared to the 3 day LCD supplemented with the rice flour placebo control.
| Condition | Intervention | Phase |
|---|---|---|
|
Appetite and Hunger, Suppression Blood Glucose, Postprandial |
Dietary Supplement: PolyGlycopleX (PGX) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Prospective, Single Crossover, Randomized, Double Blind Placebo Controlled Trial Evaluating Subjective Ratings of Appetite and Glucoregulation of a Low Calorie Diet Supplemented With a High Viscosity Polysaccharide (PolyGlycopleX - PGX) vs. Rice Flour Control, in Overweight and Moderately Obese Females. |
Resource links provided by NLM:
Further study details as provided by Canadian Center for Functional Medicine:
Primary Outcome Measures:
- Change in the ratings of the variables in the Appetite Visual Analog Scale and the overall Appetite Score. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in 2-hour postprandial areas under the curve (AUC) and 24 hour blood glucose (CGMS) profiles. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 32 |
| Study Start Date: | June 2010 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PolyGlycopleX (PGX)
5 grams of PGX 3 times per day with each main meal (breakfast, lunch and dinner)
|
Dietary Supplement: PolyGlycopleX (PGX)
powder, 5 grams, 3 times per day at each main meal (breakfast, lunch and dinner) for a total of 3 days
|
|
Placebo Comparator: Rice flour
5 grams of rice flour 3 times per day at each main meal (breakfast, lunch and dinner)
|
Dietary Supplement: PolyGlycopleX (PGX)
powder, 5 grams, 3 times per day at each main meal (breakfast, lunch and dinner) for a total of 3 days
|
Eligibility| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- BMI 25-35 Kg/m2
Exclusion Criteria:
- Known diabetes
- Medications or natural health products that affect appetite
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108328
Locations
| Canada, British Columbia | |
| Canadian Centre for Functional Medicine | |
| Coquitlam, British Columbia, Canada, V3K6Y2 | |
| Canadian Center for Functional Medicine | |
| Coquitlam, British Columbia, Canada | |
Sponsors and Collaborators
Canadian Center for Functional Medicine
University of British Columbia
InovoBiologic Inc.
Investigators
| Principal Investigator: | Michael Lyon, MD | University of British Columbia |
More Information
No publications provided
| Responsible Party: | Scientific Officer, InovoBiologic Inc. |
| ClinicalTrials.gov Identifier: | NCT01108328 History of Changes |
| Other Study ID Numbers: | PGX Crossover Study |
| Study First Received: | April 20, 2010 |
| Last Updated: | November 30, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Canadian Center for Functional Medicine:
|
viscous fibre polysaccharide blood glucose |
postprandial appetite hunger satiety |
Additional relevant MeSH terms:
|
Epoprostenol Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses |
Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013