Clinical trial NCT02218528: Effect of a Plant-based Ingredient on Glucose Response
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: subjects
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2014-08-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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;
* HbA1C ≤ 6.5 % (48 mmol/mol).

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;
* Reported dietary habits, such as a medically prescribed/slimming diet;
* Not being used to eat breakfast;
* Reported weight loss/gain (\>10%) in the last six month before the study;
* Being an employee of Unilever or CRO;
* Allergy or intolerance to food products and aversion to food products provided during the study;
* If female: pregnant or will be planning pregnancy during the study period;
* If female: lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period.

Primary outcomes:
measure: Positive incremental post-prandial blood glucose area unde the curve
timeFrame: 120 minutes
Secondary outcomes:
measure: Positive incremental post-prandial blood glucose area under the curve
timeFrame: 180 minutes
measure: Post-prandial insulin response
timeFrame: 120 minutes
measure: Post-prandial insulin response
timeFrame: 180 minutes
measure: Assessment of gastric emptying rate
timeFrame: 10 hours
Other outcomes:
measure: Cmax
timeFrame: 120 minutes
measure: Cmax-baseline corrected
timeFrame: 120 minutes
measure: Tmax
timeFrame: 120 minutes
Locations:
city: Ahmedabad
country: India
facility: Lambda Therapeutics Research Ltd (LTRL)
Study officials:
affiliation: Lambda Therapeutics Research Ltd (LTRL)
name: Dr. Ketul Modi, MBBS
role: PRINCIPAL_INVESTIGATOR
References: