Evaluation of Subjective Ratings of Appetite and Glucoregulation of a Low Calorie Diet Supplemented With a High Viscosity Polysaccharide (PolyGlycopleX - PGX)

NCT01108328 | Completed Phase 3

• 1 other identifier: PGX Crossover Study
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Appetite and Hunger, Suppression; Blood Glucose, Postprandial

Keywords

viscous; fibre; polysaccharide; blood glucose; postprandial; appetite; hunger; satiety

Outcome Measures

Primary Outcomes (1)

• Change in the ratings of the variables in the Appetite Visual Analog Scale and the overall Appetite Score.

  3 days

Secondary Outcomes (1)

• Changes in 2-hour postprandial areas under the curve (AUC) and 24 hour blood glucose (CGMS) profiles.

  3 days

Study Arms (2)

PolyGlycopleX (PGX)

EXPERIMENTAL

5 grams of PGX 3 times per day with each main meal (breakfast, lunch and dinner)

Dietary Supplement: PolyGlycopleX (PGX)

Rice flour

PLACEBO COMPARATOR

5 grams of rice flour 3 times per day at each main meal (breakfast, lunch and dinner)

Dietary Supplement: PolyGlycopleX (PGX)

Interventions

PolyGlycopleX (PGX) DIETARY_SUPPLEMENT

powder, 5 grams, 3 times per day at each main meal (breakfast, lunch and dinner) for a total of 3 days

PolyGlycopleX (PGX); Rice flour

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- BMI 25-35 Kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Center for Functional Medicine: lead
• University of British Columbia: collaborator
• InovoBiologic Inc.: collaborator

Study Sites (2)

Canadian Centre for Functional Medicine

Coquitlam, British Columbia, V3K6Y2, Canada

Location

Canadian Center for Functional Medicine

Coquitlam, British Columbia, Canada

Location

Related Publications (1)

• Kacinik V, Lyon M, Purnama M, Reimer RA, Gahler R, Green TJ, Wood S. Effect of PGX, a novel functional fibre supplement, on subjective ratings of appetite in overweight and obese women consuming a 3-day structured, low-calorie diet. Nutr Diabetes. 2011 Dec 12;1(12):e22. doi: 10.1038/nutd.2011.18.

  PMID: 23154443 RESULT

MeSH Terms

Interventions

PolyGlycoplex

Study Officials

• Michael Lyon, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 22, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 2, 2015

Record last verified: 2015-09

Locations

CA (2)