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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: NA
Last verified: April 2014
History: No changes posted
  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:
  • Post prandial glucose peak [ Time Frame: Blood samples will be taken at fasting, 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 glucose peak in healthy overweight adults with impaired fasting glucose

  • Post prandial triglyceride peak [ Time Frame: Blood samples will be taken at fasting, 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 triglyceride peak in healthy overweight adults with impaired fasting glucose


Secondary Outcome Measures:
  • Post prandial glucose peak [ Time Frame: Blood samples will be taken at fasting, 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 glucose peak in healthy overweight adults

  • Post prandial triglyceride peak [ Time Frame: Blood samples will be taken at fasting, 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 triglyceride peak in healthy overweight adults

  • Post prandial Remnant Lipoprotein Cholesterol (RLP-Cholesterol) peak and insulin [ Time Frame: Blood samples will be taken at fasting, 10, 20, 30, 40, 50 60, 75 90,105, 120,150,180,210 & 240 minutes ] [ Designated as safety issue: No ]
    To evaluate the effects of a fibre rich health food drink on post prandial RLP-Cholesterol peak and insulin in healthy overweight adults with and without impaired fasting glucose

  • Post prandial changes in serum triglycerides, blood glucose, RLP-Cholesterol and insulin [ Time Frame: Blood samples will be taken at fasting, 10, 20, 30, 40, 50 60, 75 90,105, 120,150,180,210 & 240 minutes ] [ Designated as safety issue: No ]
    To estimate the effect of a fibre rich health food drink on the extent of the postprandial changes in serum triglycerides, blood glucose, RLP-Cholesterol and insulin by calculating the incremental area under the curve (IUAC)

  • Tmax for glucose, triglycerides and serum RLP-Cholesterol [ Time Frame: Blood samples will be taken at fasting, 10, 20, 30, 40, 50 60, 75 90,105, 120,150,180,210 & 240 minutes ] [ Designated as safety issue: No ]
    To estimate the effect of a fibre rich health food drink on the time when the maximum post prandial concentration of blood glucose, serum triglycerides and serum RLP-Cholesterol is reached (Tmax)


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: RH01899
Study First Received: April 17, 2014
Last Updated: April 17, 2014
Health Authority: India: Independent Ethics Committee

Keywords provided by GlaxoSmithKline:
fibre
impaired fasting glucose
overweight

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

ClinicalTrials.gov processed this record on November 24, 2014