Dose Response Study of a Natural Extract for Reducing Post Prandial Blood Glucose

Study Overview
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Brief Summary
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Randomized, balanced incomplete block design dose response study of efficacy, with 4 different dosages of mulberry fruit powdered extract added to cooked rice compared to a reference treatment (cooked rice only).

Detailed Description
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Dose response study with 4 dosages of mulberry fruit powdered extract (0.37, 0.75, 1.12 and 1.5 g) added to cooked rice, compared to cooked rice only(reference) on post prandial blood glucose response in healthy Indian adults. In addition, 1.5 g of mulberry fruit powdered extract was added to instant rice porridge and compared to instant rice porridge only as positive control (replication of previous research. In total there were 7 test products in the study: 5 active treatments and 2 reference treatments. The study was a cross-over study (4 interventions per subject, 4 out of the 7 test products). The recovery period between treatments was at least seven days.

Official Title
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A Natural Extract for Reducing the Post Prandial Blood Glucose Response in Healthy Indian Adults: A Dose-response Study of Efficacy and Tolerance

Conditions
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Blood Glucose

Intervention / Treatment
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* Other: Boiled Rice
* Other: Boiled Rice+0.37 gr mulberry fruit powdered extract
* Other: Boiled Rice+0.75 gr mulberry fruit powdered extract
* Other: Boiled Rice+1.12 gr mulberry fruit powdered extract
* Other: Boiled Rice+1.50 gr mulberry fruit powdered extract
* Other: Rice Porridge
* Other: Rice porridge+1.50 gr mulberry fruit powdered extract


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 ≥ 20 and ≤ 50.0 years of age; BMI of ≥18.0 and ≤ 25.0 kg/m2; Apparently healthy: no medical conditions which might effect study measurements as judged by the study physician or measured by questionnaire, and/or assessed by hematology, 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) as judged by the research physician. Exclusion Criteria: Being an employee of Unilever of Lambda; 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; High intake of alcohol (>120 mL/week); Reported use of medically prescribed/slimming diet; Reported participation in night shifts (between 23.00 and 6.00 hrs); 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
Interventional Model Description: Randomized, balanced incomplete block design dose response study of efficacy,
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Boiled Rice<br>63 g of raw rice was cooked. | Other: Boiled Rice<br> <br> |
| Experimental: Boiled Rice+0.37 gr extract<br>63 g of raw rice was cooked and 0.37 gr mulberry fruit powdered extract added and mixed | Other: Boiled Rice+0.37 gr mulberry fruit powdered extract<br> <br> |
| Experimental: Boiled Rice+0.75 gr extract<br>63 g of raw rice was cooked and 0.75 gr mulberry fruit powdered extract added and mixed | Other: Boiled Rice+0.75 gr mulberry fruit powdered extract<br> <br> |
| Experimental: Boiled Rice+1.12 gr extract<br>63 g of raw rice was cooked and 1.12 gr mulberry fruit powdered extract added and mixed | Other: Boiled Rice+1.12 gr mulberry fruit powdered extract<br> <br> |
| Experimental: Boiled Rice+1.50 gr extract<br>63 g of raw rice was cooked and 1.50 gr mulberry fruit powdered extract added and mixed | Other: Boiled Rice+1.50 gr mulberry fruit powdered extract<br> <br> |
| Placebo Comparator: Rice porridge<br>60 g of rice porridge was rehydrated with 300 ml boiling hot water | Other: Rice Porridge<br> <br> |
| Active Comparator: Rice porridge+1.50 gr extract<br>60 g of rice porridge was rehydrated with 300 ml boiling hot water and 1.50 gr mulberry fruit powdered extract added and mixed | Other: Rice porridge+1.50 gr mulberry fruit powdered extract<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 after test product intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial insulin | Post-prandial serum insulin | Total area under the insulin versus time curves between 0 (before) and 2 hours after study product intake |