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

Canadian Center for Functional Medicine

Status and phase: Completed; Phase 3

Conditions: Appetite and Hunger, Suppression; Blood Glucose, Postprandial

Treatments: Dietary Supplement: PolyGlycopleX (PGX)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01108328

PGX Crossover Study

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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35 participants in 2 patient groups, including a placebo group

PolyGlycopleX (PGX)

Experimental group

Description:

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

Treatment:

Dietary Supplement: PolyGlycopleX (PGX)

Rice flour

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: PolyGlycopleX (PGX)