The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population

Study Overview
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Brief Summary
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The primary aim of this study is to evaluate the effect of a fibre rich health food drink on the post prandial glucose and triglyceride peak in healthy overweight adults with impaired fasting glucose (IFG). The study is randomised, stratified, double blind, two treatments, two period cross over study.

Official Title
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The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population

Conditions
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Impaired Fasting Glucose

Intervention / Treatment
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* Dietary Supplement: 25% fibre
* Dietary Supplement: 0% fibre


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy overweight male and female participants Age 18-75 years BMI ≥25<35 Kg/m2 Exclusion Criteria: Pregnancy/breast-feeding Allergy/Intolerance Anaemic participants: Hb <10g/dL Diabetic participants: fasting blood glucose >125 mg/dL Serum Aspartate Transaminase, Alkaline Phosphatase and Serum albumin level 3 times the upper limit of normal range Participants on other medications (lipid lowering drugs, oral hypoglycemics)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water | Dietary Supplement: 25% fibre<br>* Test is a powdered beverage with an active component of 25% of fibre (resistant maltodextrin)<br>|
| Placebo Comparator: Placebo<br>No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water | Dietary Supplement: 0% fibre<br>* Placebo is an energy matched powdered beverage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax for Glucose in IFG Status Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults with impaired fasting glucose (IFG) | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| Cmax for Triglyceride in IFG Status Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults with IFG | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax for Glucose in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| AUC for Glucose in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for glucose in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| Tmax for Glucose in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on the time when maximum post prandial concentration is reached (Tmax) of blood glucose in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| Cmax for Triglyceride in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| AUC for Triglycerides in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for triglycerides in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| Tmax for Triglycerides in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on Tmax of triglycerides in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| Cmax for RLP Cholesterol in IFG Status Participants | To evaluate the effect of fibre rich health food drink on post prandial Remnant Lipoprotein Cholesterol (RLP Cholesterol) peak (Cmax) in healthy overweight adults with IFG | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| AUC for RLP Cholesterol in IFG Status Participants | To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults with IFG | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| Tmax for RLP Cholesterol in IFG Status Participants | To evaluate the effect of fibre rich health food drink on Tmax for RLP Cholesterol in healthy overweight adults with IFG | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| Cmax for RLP Cholesterol in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on post prandial RLP Cholesterol peak (Cmax) in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| AUC for RLP Cholesterol in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| Tmax for RLP Cholesterol in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on Tmax of RLP Cholesterol in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| Cmax for Insulin in IFG Status Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults with IFG | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| AUC for Insulin in IFG Status Participants | To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults with IFG | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| Tmax for Insulin in IFG Status Participants | To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults with IFG | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| Cmax for Insulin in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| AUC for Insulin in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 
| Tmax for Insulin in Overweight Healthy Participants | To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibre, overweight, impaired fasting glucose