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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02119325
First received: April 17, 2014
Last updated: May 11, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention
Impaired Fasting Glucose
Dietary Supplement: 25% fibre
Dietary Supplement: 0% fibre

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Cmax for Glucose in IFG Status Participants [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    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)

  • Cmax for Triglyceride in IFG Status Participants [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults with IFG


Secondary Outcome Measures:
  • Cmax for Glucose in Overweight Healthy Participants [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    To evaluate the effect of fibre rich health food drink on Tmax for RLP Cholesterol in healthy overweight adults with IFG

  • Cmax for RLP Cholesterol in Overweight Healthy Participants [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults

  • Tmax for RLP Cholesterol in Overweight Healthy Participants [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults with IFG

  • Tmax for Insulin in IFG Status Participants [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes ] [ Designated as safety issue: No ]
    To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults


Enrollment: 96
Study Start Date: September 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test
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
Test is a powdered beverage with an active component of 25% of fibre (resistant maltodextrin)
Placebo Comparator: Placebo
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
Placebo is an energy matched powdered beverage

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02119325

Locations
India
Lambda Therapeutic Research Ltd
Ahmedabad, Gujarat, India, 380 061
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02119325     History of Changes
Other Study ID Numbers: 202180, RH01899
Study First Received: April 17, 2014
Results First Received: June 5, 2014
Last Updated: May 11, 2015
Health Authority: India: Independent Ethics Committee

Keywords provided by GlaxoSmithKline:
fibre
overweight
impaired fasting glucose

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 30, 2015