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A crossover trial was carried out in healthy volunteers aged 45-70 years and BMI <30 kg/m2. Subjects consumed a Antioxidant Supplement (AS) containing 65 mg of punicalagin mixed with 3.3 mg of hydroxytyrosol 3 times daily or a Control Supplement (CS) with maltodextrin for an 8 wk each phase with 4-wk rest period. Supplementation order was randomly assigned and the consumption of derivative products of punicalagin and/or hydroxytyrosol restricted. The endothelial function parameters (brachial artery flow-mediated dilation (FMD), biochemical markers), inflammatory markers and nutritional status were evaluated before and after each phase. Previously a pilot study was completed with no placebo (n=30) to determinate the effective dose of Functional Supplement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antioxidant supplement | Experimental | Treatment consist of consuming 65g of punicalagin and 3,3g of hydroxytyrosol (plus 331,7g of maltodextrin) three times daily, during 8 weeks. |
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| Control supplement | Placebo Comparator | Treatment consist of consuming 400g of maltodextrin three times daily, during 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| punicalagin and hydroxytyrosol mixture | Dietary Supplement | Antioxidant Supplement (punicalagin and hydroxytyrosol mixture) During one period of crossover study (I or II) volunteers consume daily of functional supplement during 8 weeks. Additionally, volunteers must follow guidelines for healthy diet and physical activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Inflammatory markers after 8 weeks treatment | Inflammatory markers (Fibrinogen, gelsolin, thrombospondin, interleukin 6 and PCR) will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II | 0, 8, 12 and 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oxidative Stress Parameters | Parameters measured were: plasma antioxidant capacity (FRAP, ferric reducing antioxidant power) and lipidic peroxidation (TBARS, thiobarbituric acid reactive substances assay), oxidized LDL, paraoxonase 1, F2-isoprostanes. Will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II. | 0, 8, 12 and 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | Madrid | 28061 | Spain |
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| Label | URL |
|---|---|
| Institute for Health Research IdiPAZ | View source |
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| ID | Term |
|---|---|
| C115642 | punicalagin |
| C005975 | 3,4-dihydroxyphenylethanol |
| C008315 | maltodextrin |
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| Control supplement (maltodextrin) | Dietary Supplement | During one period of crossover study (I or II) volunteers consume daily of functional supplement during 8 weeks. Additionally, volunteers must follow guidelines for healthy diet and physical activity. |
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| Change in Glucose Metabolism | Parameters measured were: glucose, basal insulin, HbA1c (in diabetic patients), HOMA (homeostasis model assessment ) index (glycemic insulin sensitivity index was calculated using the formula: HOMA-IR ( (homeostasis model assessment insulin resistance) = fasting glucose (mmol/l)/fasting immunoreactive insulin (mU/ml)/22•5).Will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II | 0, 8, 12 and 20 weeks |
| Change in Lipid profile | Parameters measured were: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides. Will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II | 0, 8, 12 and 20 weeks |
| Change in Endothelial function | Parameters measured were: Brachial artery flow-mediated dilation (FMD), blood pressure, eNOS, vascular endothelial cell adhesion molecule -1 and p-selectin. Will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II | 0, 8, 12 and 20 weeks |
| Change in Coagulation markers | Parameters measured were: Prothrombin time and activity, INR. Will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II | 0, 8, 12 and 20 weeks |
| Change in Anthropometric and body composition parameters | Parameters measured were: Weight, Height and waist circumference, muscle mass percentage (MM%), fat mass percentage (FM%), free fat mass percentage(FM%). Will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II | 0, 8, 12 and 20 weeks |
| Adverse effects | Parameters measured were: transaminases and creatinine. Will be evaluated during all the study visits | 0 to 20 weeks |
| Adherence and Tolerance Parameters | Parameters measured were: adherence and tolerance to the products. Will be evaluated during all study visits. | 0 to 20 weeks |