Healthy Subjects
Conditions
Keywords
Blood glucose
Brief summary
The study is designed to determine the extent to which a plant-based ingredient on different food formats affect blood glucose responses in healthy subjects
Interventions
DIETARY_SUPPLEMENTplant-based dietary supplement
OTHERPlacebo
Sponsors
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Willing to give consent to participate in the study in writing; * Healthy male and female subjects, between the age of ≥20 and ≤50 yrs of age at first screening visit; * Body Mass Index (BMI) between ≥18 and ≤ 25 kg/m2; * Apparently healthy: no medical conditions which might affect study measurement, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis; * Willing to comply to study protocol during the study; * Agreeing to be informed about medically relevant personal test-results by study physician; * Willing to refrain from drinking of alcohol on and one day before the blood withdrawal; * Fasting blood glucose value of volunteer 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)
Exclusion criteria
* Being an employee of Unilever or CRO; * Chronic smokers, tobacco chewers and drinkers; * Participation in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the screening period; * Use of medication which interferes with study measurements including vitamins, tonics; * Reported intense exercise ≥10 h/week; * Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening * Blood donation for 2 months prior to screening; * Urine analysis that showed any drug abuse; * Allergy to any food or cosmetics; * If female, not being pregnant or planning pregnancy during the study period; * If female, lactating or has been lactating for 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 under the curve | 120 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Post-prandial insulin area under the curve | 120 minutes |
Countries
India
Outcome results
None listed