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

Not Applicable

Completed

• Conditions: Impaired Fasting Glucose
• Interventions: Dietary Supplement: 0% fibre; Dietary Supplement: 25% fibre

• Registration Number: NCT02119325
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2013-10
• Study First Submitted: 2014-04-17
• Study First Submitted QC: 2014-04-17
• Study First Posted: 2014-04-21
• Results First Submitted: 2014-06-05
• Status Verified: 2015-04
• Results First Submitted QC: 2015-05-11
• Last Update Submitted: 2015-05-11
• Results First Posted: 2015-05-15
• Last Update Posted: 2015-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Healthy overweight male and female participants
• Age 18-75 years
• BMI ≥25<35 Kg/m2

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	0% fibre	No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water
Test	25% fibre	Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lambda Therapeutic Research Ltd; 🇮🇳 Ahmedabad, Gujarat, India