Last updated: 11/03/2018 22:15:21

The effect of a nutritional supplement on post prandial glucose and lipids in an adult population

GSK study ID
202180
See study documents
Clinicaltrials.gov ID
NCT02119325
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: The effect of a nutritional supplement on post prandial glucose and lipids in an adult population
Trial description: 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Cmax for glucose in IFG status participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Cmax for triglyceride in IFG status participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Secondary outcomes:

Cmax for glucose in overweight healthy participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

AUC for glucose in overweight healthy participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Tmax for glucose in overweight healthy participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Cmax for triglyceride in overweight healthy participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

AUC for triglycerides in overweight healthy participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Tmax for triglycerides in overweight healthy participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Cmax for RLP Cholesterol in IFG status participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

AUC for RLP Cholesterol in IFG status participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Tmax for RLP Cholesterol in IFG status participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Cmax for RLP Cholesterol in overweight healthy participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

AUC for RLP Cholesterol in overweight healthy participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Tmax for RLP Cholesterol in overweight healthy participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Cmax for insulin in IFG status participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

AUC for insulin in IFG status participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Tmax for insulin in IFG status participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Cmax for insulin in overweight healthy participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

AUC for insulin in overweight healthy participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Tmax for insulin in overweight healthy participants

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Interventions:
  • Dietary supplement: 25% fibre
  • Dietary supplement: 0% fibre
    • Enrollment:
    96
    Primary completion date:
    2013-26-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Impaired fasting glucose
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    September 2013 to October 2013
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 75 years
    Accepts healthy volunteers
    Yes
    • Healthy overweight male and female participants
    • Age 18-75 years
    • Pregnancy/breast-feeding
    • Allergy/Intolerance
    Inclusion and exclusion 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)

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    Lambda Therapeutic Research Ltd
    Ahmedabad, Gujarat, India, 380 061
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2013-26-10
    Actual study completion date
    2013-26-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website