Clinical trial NCT02119325: The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population
Official title: The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Fasting Glucose
Keywords: fibre
overweight
impaired fasting glucose
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: 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
measure: 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:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Lambda Therapeutic Research Ltd
state: Gujarat
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: