Post-prandial Glucose in Healthy Indian Subjects

Study Overview
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Brief Summary
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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

Official Title
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Effect of Plant-based Ingredient in Different Food Formats on Post-prandial Glucose in Healthy Indian Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Dietary Supplement: plant-based dietary supplement
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Reference food format<br>reference food format with and without plant-based ingredient added | Dietary Supplement: plant-based dietary supplement<br> <br> Other: Placebo<br> <br> |
| Experimental: Food format one<br>Food format one with and without plant-based ingredient added | Dietary Supplement: plant-based dietary supplement<br> <br> Other: Placebo<br> <br> |
| Experimental: Food format two<br>Food format two with and without plant-based ingredient added | Dietary Supplement: plant-based dietary supplement<br> <br> Other: Placebo<br> <br> |
| Experimental: Food format three<br>Food format three with and without plant-based ingredient added | Dietary Supplement: plant-based dietary supplement<br> <br> Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive incremental post-prandial blood glucose area under the curve |  | 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial insulin area under the curve |  | 120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood glucose