Status:
COMPLETED
Effect of a Plant-based Ingredient on Glucose Response
Lead Sponsor:
Unilever R&D
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
NA
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
- 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
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02218528
Start Date
August 1 2014
End Date
September 1 2014
Last Update
February 18 2015
Active Locations (1)
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1
Lambda Therapeutics Research Ltd (LTRL)
Ahmedabad, India