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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Appetite and Hunger, Suppression, Blood Glucose, Postprandial

Intervention / Treatment
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* Dietary Supplement: PolyGlycopleX (PGX)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PolyGlycopleX (PGX)<br>5 grams of PGX 3 times per day with each main meal (breakfast, lunch and dinner) | Dietary Supplement: PolyGlycopleX (PGX)<br>* powder, 5 grams, 3 times per day at each main meal (breakfast, lunch and dinner) for a total of 3 days<br>|
| Placebo Comparator: Rice flour<br>5 grams of rice flour 3 times per day at each main meal (breakfast, lunch and dinner) | Dietary Supplement: PolyGlycopleX (PGX)<br>* powder, 5 grams, 3 times per day at each main meal (breakfast, lunch and dinner) for a total of 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the ratings of the variables in the Appetite Visual Analog Scale and the overall Appetite Score. |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 2-hour postprandial areas under the curve (AUC) and 24 hour blood glucose (CGMS) profiles. |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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viscous, fibre, polysaccharide, blood glucose, postprandial, appetite, hunger, satiety