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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum A | Experimental |
| |
| Verum B | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verum A | Dietary Supplement | Formulation of polyphenols from olive leaf extract, blackcurrant extract, pomegranate extract, grapefruit extract |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Alcaraz | UCAM (Universidad Catolica San Antonio de Murcia) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCAM Universidad Católica San Antonio de Murcia | Guadalupe | Murcia | 30107 | Spain |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Double blind randomized parallel study
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| Verum B | Dietary Supplement | Formulation of polyphenols from olive leaf extract, blackcurrant extract, white kidney bean extract, chromium picolinate and Zinc bisglycinate |
|
| Placebo | Dietary Supplement | Micro crystalline cellulose |
|
| 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 |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |