An Exploratory Study of a Plant-based Ingredient for Reducing the Post-prandial Blood Glucose Response in Healthy Indian Adults, When Administered With a Meal

Unilever R&D1 site in 1 country48 target enrollmentAugust 2014

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Unilever R&D
Enrollment: 48
Locations: 1
Primary Endpoint: Positive incremental post-prandial blood glucose area unde the curve
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is designed to determine the extent to which a plant-based ingredient is able to modulate blood glucose response when administered with a meal.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

September 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Unilever R&D

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy males and females, age at start of the study ≥ 18 and ≤ 50 years;
•Apparently healthy: no medical conditions which might affect the study measurements, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
•Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
•Haemoglobin level within clinically acceptable range (for male 12 to 17 gm/dL and for females 11 to 15 gm/dL; both inclusive) as judged by the research physician;
•Body mass index (BMI) ≥ 18,0 and ≤ 25,0 kg/m2;
•Agreeing to be informed about medically relevant personal test-results by study physician;
•Willing to comply to study protocol during study;
•Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
•Accessible veins on arms as determined by examination at screening;
•Being literate;

Exclusion Criteria

•Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism;
•Any history of gastro-intestinal disorders (including frequent diarrhoea for example);
•Blood donation in the past 2 months;
•Reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study;
•Reported participation in night shift work two weeks prior to pre-study investigation or during the study. Night work is defined as working between 23.00 PM and 6.00 AM;
•Reported intense sporting activities \> 10h/w;
•Consumption of ≥120 ml of alcoholic drinks for males and females in a typical week;
•Drug abuse as indicated by urine analysis;
•Chronic smokers, tobacco chewers and drinkers;
•Use of any medication, including supplements and traditional medicine;

Outcomes

Primary Outcomes

Positive incremental post-prandial blood glucose area unde the curve

Time Frame: 120 minutes

Secondary Outcomes

Positive incremental post-prandial blood glucose area under the curve(180 minutes)
Post-prandial insulin response(180 minutes)
Assessment of gastric emptying rate(10 hours)