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

Impaired Fasting Glucose Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119325
• Other study ID #: 202180
• Secondary ID: RH01899
• Status: Completed
• Phase: N/A
• First received: April 17, 2014
• Last updated: May 11, 2015
• Start date: September 2013

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Impaired Fasting Glucose
• Prediabetic State

Intervention

Dietary Supplement:
• 25% fibre
Test is a powdered beverage with an active component of 25% of fibre (resistant maltodextrin)
• 0% fibre
Placebo is an energy matched powdered beverage

Locations

Country	Name	City	State
India	Lambda Therapeutic Research Ltd	Ahmedabad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No