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

NCT ID: NCT01108328

Last Updated: 2015-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2010-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PolyGlycopleX (PGX)

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

Group Type: EXPERIMENTAL

PolyGlycopleX (PGX)

Intervention Type: DIETARY_SUPPLEMENT

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

Rice flour

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

Group Type: PLACEBO_COMPARATOR

PolyGlycopleX (PGX)

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

PolyGlycopleX (PGX)

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: collaborator

InovoBiologic Inc.

INDUSTRY

Sponsor Role: collaborator

Canadian Center for Functional Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Lyon, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Canadian Centre for Functional Medicine

Coquitlam, British Columbia, Canada

Canadian Center for Functional Medicine

Coquitlam, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 23154443 (View on PubMed)

Other Identifiers

PGX Crossover Study

Identifier Type: -

Identifier Source: org_study_id