Exploratory Study of Efficacy on Selected Natural Extracts Reducing Post Prandial Blood Glucose Response

Study Overview
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Brief Summary
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Randomized, balanced, incomplete block design exploratory study of efficacy, with 8 active treatments (4 treatments per subject; 35 or 37 subjects per treatment) compared to a reference treatment (all 72 subjects).

Detailed Description
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Incomplete block design cross over study in which the subjects consumed commercial rice porridge (60 grams of extruded rice to which 300 ml of boiling water was added) in the morning in a fasted state. On each visit one of the seven different natural exacts was mixed into this porridge just before consumption. The reference was consumed by all subjects and consisted of plain porridge with no extract added.

Official Title
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An Exploratory Study of Efficacy and Tolerance on Selected Natural Extracts, With the Potential of Reducing Post Prandial Blood Glucose Response, in Healthy Indian Adult Subjects

Conditions
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Blood Glucose

Intervention / Treatment
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* Other: Mulberry fruit
* Other: Mulberry leaf
* Other: White bean
* Other: Apple
* Other: Elderberry
* Other: Turmeric
* Other: Rice porridge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is the volunteer willing to give his consent to participate in the study in writing? Is the volunteer between the age of >20 and <50 yrs? Is the volunteer's Body Mass Index (BMI) in between >18 and <25 kg/m2? Lactase deficient as indicated by screening test1 Is the volunteer apparently healthy? [No medical conditions which might affect study measurement, as judged by study physician or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis] Is the volunteer willing to comply to study protocol during the study? Is the volunteer agreeing to be informed about medically relevant personal test-results by study physician? Is the volunteer willing to refrain from drinking of alcohol on and one day before the blood withdrawal? Is the fasting blood glucose value of the volunteer is >3.4 and <6.1 mmol/ litre (i.e. 62-110 mg/dl)? Is the Haemoglobin level within normal reference range as judged by the research physician? Is the volunteer literate? Exclusion Criteria: Is the volunteer an employee of Unilever, Hindustan Lever, or Lambda Therapeutics Research? Has the volunteer participated in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the study period? Does the volunteer take too much of alcohol (> 120 ml / week)? Is the volunteer on a medically prescribed/slimming diet? Does the volunteer work in night shifts (between 23.00 and 6.00 hrs) in the week preceding or during the study? Is the volunteer using any medication including traditional medicines, vitamins, tonics which might interfere with study measurements, as judged by the PI and/or study physician? Does the volunteer engage in intense exercise > 10h/week? (Intense exercise is defined as exercise which induces sweating and causes sufficient breathlessness to limit conversation) Has the volunteer reported weight loss/gain > 10% of body weight in the 6 months preceding screening? Has the volunteer donated any blood for 2 months prior to screening visit? Does the volunteer urine analysis show any drug abuse? Is the volunteer allergic to any food or cosmetics? Does the volunteer smoke or consume tobacco in any form, and/or was smoking or consuming tobacco in any form for 6 months preceding the study and/or will be smoking or consuming tobacco in any form, during the study? If female, is the volunteer pregnant or will she be planning pregnancy during the study period? If female, is the volunteer 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
Interventional Model Description: Randomized, balanced, incomplete block design exploratory study of efficacy, with 8 active treatments (4 treatments per subject; 35 or 37 subjects per treatment) compared to a reference treatment (all 72 subjects).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mulberry fruit extract<br>1.5 g of mulberry fruit powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water | Other: Mulberry fruit<br> <br> |
| Experimental: Mulberry leaf extract<br>1.0 g of mulberry leaf powdered extract mixed into aa bowl containing 60 g of extruded rice + 300 ml of boiling water | Other: Mulberry leaf<br> <br> |
| Experimental: White bean extract<br>3 g of white bean powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water | Other: White bean<br> <br> |
| Experimental: Apple extract<br>2 g of apple powdered extract standardized in phloridzin mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water | Other: Apple<br> <br> |
| Experimental: Elderberry extract<br>2 g of elderberry powder extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water | Other: Elderberry<br> <br> |
| Experimental: Turmeric extract<br>0.18 g of curcumin powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water | Other: Turmeric<br> <br> |
| Experimental: Turmeric extract + Apple extract<br>0.18 g of curcumin powdered extract + 2 g of apple powdered extract standardized in phloridzin mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water | Other: Apple<br> <br> Other: Turmeric<br> <br> |
| Experimental: Turmeric extract + Elderberry extract<br>0.18 g of curcumin powdered extract + 2 g of elderberry powder extract mixed into aa bowl containing 60 g of extruded rice + 300 ml of boiling water | Other: Elderberry<br> <br> Other: Turmeric<br> <br> |
| Placebo Comparator: Rice porridge control<br>Bowl containing 60 g of extruded rice + 300 ml of boiling water | Other: Rice porridge<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial blood glucose | Glucose concentration in venous plasma | Positive incremental Area under the glucose versus time Curve between 0 (before) and 2 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breath hydrogen excretion | Hydrogen gas in exhaled breath. When a subject produced 10 ppm hydrogen or more above the basal breath hydrogen level the treatment was regarded as a positive | Fifteen minutes before (basal) and 65, 125, 185, 245, 305, 365 and 425 minutes after the ingestion of the test products | 
| Intestinal discomfort | An intestinal discomfort questionnaire was administered. The questionnaire asked whether subjects had experienced 1) flatulence, 2) nausea, 3) bloating or 4) pain in the bowels. Percentage of Yes scores was calculated per discomfort. | Ten minutes before (baseline) and at 130, 250, 370 and 420 minutes after the ingestion of the test products. | 
| Stool consistency and number of stools | Stool consistency was evaluated by semi-quantitative Bristol scale (score between 1 = constipation and 7 = watery diarrhea). | 24 hours before study product intake, during 7 hour the test day and in the 17 hours after the test day (telephone interview). |