The Effect of a Natural Extract on the Post-prandial Blood Glucose Response After Bread Consumption: a Dose-response of Efficacy

Study Overview
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Brief Summary
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This study is designed to identify the minimal effective tested dose of fruit extract consumed with a bread which provides a reduction in venous post-prandial blood glucose compared to a reference bread.

Official Title
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The Effect of a Natural Extract on the Post-prandial Blood Glucose Response After Bread Consumption: a Dose-response of Efficacy

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: no added fruit extract
* Dietary Supplement: fruit extract
* Dietary Supplement: fruit extract
* Dietary Supplement: fruit extract
* Dietary Supplement: fruit extract


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2. Apparently healthy males and females: no medical conditions which might affect the study measurements including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases. Fasting blood glucose value of subjects ≥ 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 except paracetamol, within 14 days before day 1. Blood donation in the past 3 months and/or during the study. Reported intense sporting activities > 10 h/week. Consumption of > 14 units (female subjects) and > 21 units (male subjects) alcoholic drinks in a typical week. Reported dietary habits: medically prescribed diet, slimming diet, not used to eat 3 meals a day, vegetarian. If female, is pregnant (or has been pregnant during the last < 3 months) or will be planning pregnancy during the study period. If female, is lactating or has been lactating in the 6 weeks before screening and/or during the study period. Dislike, known allergy or intolerance to test products or other food products provided during the study.

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: Reference<br>No added fruit extract | Dietary Supplement: no added fruit extract<br> <br> |
| Active Comparator: Active 1<br>lowest dose of fruit extract | Dietary Supplement: fruit extract<br> <br> |
| Active Comparator: Active 2<br>low dose of fruit extract | Dietary Supplement: fruit extract<br> <br> |
| Active Comparator: Active 3<br>medium dose of fruit extract | Dietary Supplement: fruit extract<br> <br> |
| Active Comparator: Active 4<br>high dose of fruit extract | Dietary Supplement: fruit extract<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 response |  | 120 minutes | 
| Post-prandial insulin response |  | 180 minutes | 
| AUC of fruit extract calculated by a non-compartmental model |  | 180 minutes | 
| AUC of fruit extract calculated by a population model |  | 180 minutes | 
| Positive incremental post-prandial blood glucose area under the curve |  | 180 minutes | 

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