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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2013-26-10
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
Completed
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
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