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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Impaired Fasting Glucose

Treatments: Dietary Supplement: 0% fibre; Dietary Supplement: 25% fibre

Study type: Interventional

Funder types: Industry

Identifiers

NCT02119325

202180

RH01899 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

96 participants in 2 patient groups, including a placebo group

Test

Experimental group

Description:

Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water

Treatment:

Dietary Supplement: 25% fibre

Placebo

Placebo Comparator group

Description:

No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water

Treatment:

Dietary Supplement: 0% fibre