OXXYNEA® GS: Study for Glycaemia Management

Study Overview
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Brief Summary
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The aim of this study is to develop a proof of concept establishing a causal relationship between glycemia improvement through combination of polyphenols-rich botanical extracts or polyphenols-rich botanical extracts associated with white kidney bean extract and chromimum picolinate + zinc bisglycinate with chronic supplementation. Chronic glycemia improvement will be assessed by following the evolution of HbA1c, postprandial glucose and insulin kinetics, and questionnaires. The study design is double blinded randomized with 3 arms and 29 volunteers per arm.

Official Title
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Evaluation of Two Plant Formulations for the Management of Glycemia on Pre-diabetic Participants

Conditions
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Prediabetic State, Overweight

Intervention / Treatment
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* Dietary Supplement: Verum A
* Dietary Supplement: Verum B
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fasting Plasma Glucose 100 - 125 mg/dL HbA1c: 5.7-6.5 % Both sexes Overweight BMI range (25-30 Kg/m2) Age: 20-50 years old Exclusion Criteria: Metabolic/Chronical disease Menopausal women Being pregnant, breastfeeding or wanting to have a baby Former obese with a history of yoyo effect Have been involved in a weight loss program in the past 12 months or subjected to weight reduction surgery Having started or quit smoking, having a high alcohol consumption Have in the past been in a long-term antibiotherapy (1 month or more) and/or a regular antibiotherapy in the past 12 months Allergy to olive, blackcurrant, pomegranate, grapefruit, white kidney bean, or corn.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind randomized parallel study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum A<br> | Dietary Supplement: Verum A<br>* Formulation of polyphenols from olive leaf extract, blackcurrant extract, pomegranate extract, grapefruit extract<br>|
| Experimental: Verum B<br> | Dietary Supplement: Verum B<br>* Formulation of polyphenols from olive leaf extract, blackcurrant extract, white kidney bean extract, chromium picolinate and Zinc bisglycinate<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Micro crystalline cellulose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Evaluation of changes in the glycated haemoglobin measurements in comparison of the 3 groups | 12 weeks | 
| Post prandial glycemia | Evaluation of changes in acute and chronic glycemia: Changes in the postprandial glucose measurements in comparison of the 3 groups after the standardized breakfast at baseline, 4th, 8th and 12th week. | 12 weeks | 
| Post prandial insulemia | Evaluation of changes in acute glycemia: Change in postprandial insulin in comparison of the 3 groups after the standardized breakfast at baseline, 4th, 8th and 12th week. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Change in the body weight measurements in comparison of the 3 groups | 12 weeks | 
| Dual-energy X-ray (DEXA) | Evaluation of changes in fat mass and lean mass using a Dual-energy X-ray absorptiometry and compare amongst 3 groups | 12 weeks | 
| Magnetic resonance imaging (MRI) | Evaluation of changes in various fat layers (visceral, subcutaneous and deep subcutaneous) using a MRI and compare amongst 3 groups | 12 weeks | 
| Short Form 12 (SF-12) questionnaire | Evaluation of changes in responses to SF-12 questionnaire. SF-12 questionnaire is a health related questionnaire with 12 questions. The total score range from 0-100, with higher score indicating better health status. | 12 weeks |