Effects of a Dietary Fibre Supplementation of a Low Calorie Diet on Appetite and Body Weight

Canadian Center for Functional Medicine

Status and phase: Completed; Phase 3

Conditions: Weight Loss; Appetite Suppression

Treatments: Dietary Supplement: PolyGlycopleX (PGX); Dietary Supplement: Rice flour

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01109199

PGX RCT Study

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI 25 - 35 Kg/m2

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

PolyGlycopleX (PGX)

Experimental group

Treatment:

Dietary Supplement: PolyGlycopleX (PGX)

Rice Flour

Placebo Comparator group

Treatment:

Dietary Supplement: Rice flour