Natural Fruit Extract Versus the Assumed Key Active Compound in Reducing the Post-prandial Blood Glucose Level

Study Overview
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Brief Summary
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This study is designed to test bioequivalence of a assumed key active compound vs. natural fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for assumed key active compound vs. natural extract falls between 0.8 - 1.25.

Detailed Description
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The basic study design for this Williams design consists of six distinct treatment sequences; within each of the treatment sequences the treatments are duplicated.

Official Title
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The Bioequivalence of a Natural Extract Versus the Assumed Key Active Compound in Reducing the Post-prandial Blood Glucose Levels

Conditions
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Healthy

Intervention / Treatment
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* Other: Natural fruit extract
* Other: Assumed active
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) ≥ 18.5 and ≤ 25.0 kg/m2. Apparently healthy males and females: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery [with exception of cholecystectomy and appendectomy] and inflammatory diseases). Fasting blood glucose value of subjects is ≥ 3.4 and <6.1 mmol/litre (i.e. 62- 110 mg/dl) at screening. Exclusion Criteria: Use of antibiotics within 3 months before day 1; use of any other medication within 14 days before day 1 except for both paracetamol and hormonal contraception.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Rice only | Other: Placebo<br>* Rice only<br>|
| Active Comparator: Assumed active<br>Assumed key active consumed with rice | Other: Assumed active<br>* Assumed key active consumed with rice<br>|
| Active Comparator: Natural fruit extract<br>Natural fruit extract consumed with rice | Other: Natural fruit extract<br>* Natural fruit extract consumed with rice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of 2-h Post Prandial Blood Glucose (PPG) based on response to different treatments | +iAUC | 0-2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of 3-h PPG based on response to different treatments | +iAUC | 0-3 hours | 
| Change of 2-h and 3-h post-prandial insulin based on response to different treatments | tAUC | 0-2 hours and 0-3 hours | 
| Max plasma concentration for assumed key active | Cmax | 0-12 hours | 
| Time of max plasma concentration for assumed key active | Tmax | 0-12 hours | 
| AUC for plasma concentration versus time curve for assumed key active | AUC | 0-12 hours | 
| Half-life of elimination phase for assumed key active | t1/2 | 0-12 hours | 
| Total amount of assumed key active excreted in urine |  | 0-36 hours | 

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