Healthy
Conditions
Keywords
subjects
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.
Interventions
DIETARY_SUPPLEMENTPlant-based ingredient
DIETARY_SUPPLEMENTNo Plant-based ingredient
Sponsors
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive incremental post-prandial blood glucose area unde the curve | 120 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive incremental post-prandial blood glucose area under the curve | 180 minutes | — |
| Post-prandial insulin response | 120 minutes | — |
| Assessment of gastric emptying rate | 10 hours | GE50% (time to empty 50% of the gastric content) will be determined with paracetamol |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cmax-baseline corrected | 120 minutes | peak plasma glucose - baseline plasma glucose |
| Tmax | 120 minutes | peak time plasma glucose |
| Cmax | 120 minutes | peak plasma glucose |
Countries
India
Outcome results
None listed