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

NCT ID: NCT02119325

Last Updated: 2015-05-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

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.

Detailed Description

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Conditions

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Impaired Fasting Glucose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test

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

Group Type EXPERIMENTAL

25% fibre

Intervention Type DIETARY_SUPPLEMENT

Test is a powdered beverage with an active component of 25% of fibre (resistant maltodextrin)

Placebo

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

Group Type PLACEBO_COMPARATOR

0% fibre

Intervention Type DIETARY_SUPPLEMENT

Placebo is an energy matched powdered beverage

Interventions

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25% fibre

Test is a powdered beverage with an active component of 25% of fibre (resistant maltodextrin)

Intervention Type DIETARY_SUPPLEMENT

0% fibre

Placebo is an energy matched powdered beverage

Intervention Type DIETARY_SUPPLEMENT

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Lambda Therapeutic Research Ltd

Ahmedabad, Gujarat, India

Site Status

Countries

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India

Other Identifiers

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RH01899

Identifier Type: OTHER

Identifier Source: secondary_id

202180

Identifier Type: -

Identifier Source: org_study_id

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