Effect of a Plant-based Ingredient on Glucose Response

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 is able to modulate blood glucose response when administered with a meal.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Plant-based ingredient
* Dietary Supplement: No Plant-based ingredient


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Starchy meal<br>No Plant-based ingredient added to a starchy meal | Dietary Supplement: No Plant-based ingredient<br> <br> |
| Active Comparator: Low dose added to starchy meal<br>Plant-based ingredient in low dose added to starchy meal | Dietary Supplement: Plant-based ingredient<br> <br> |
| Placebo Comparator: Starchy meal and side dish<br>No Plant-based ingredient added to starchy meal and side dish | Dietary Supplement: No Plant-based ingredient<br> <br> |
| Active Comparator: Low dose added to starchy meal and side dish<br>Plant-based ingredient in low dose added to starchy meal and side dish | Dietary Supplement: Plant-based ingredient<br> <br> |
| Active Comparator: Medium dose added to starchy meal and side dish<br>Plant-based ingredient in medium dose added to starchy meal and side dish | Dietary Supplement: Plant-based ingredient<br> <br> |
| Active Comparator: High dose added to starchy meal and side dish<br>Plant-based ingredient in high dose added to starchy meal and side dish | Dietary Supplement: Plant-based ingredient<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 unde the curve |  | 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive incremental post-prandial blood glucose area under the curve |  | 180 minutes | 
| Post-prandial insulin response |  | 120 minutes | 
| Post-prandial insulin response |  | 180 minutes | 
| Assessment of gastric emptying rate | GE50% (time to empty 50% of the gastric content) will be determined with paracetamol | 10 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subjects