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| Name | Class |
|---|---|
| Universidad Católica San Antonio de Murcia | OTHER |
| The Scientific and Technological Research Council of Turkey | OTHER |
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The investigators objective is to carry out a placebo-controlled, dose-response, randomized clinical trial to assess the effects of polyphenols or derived metabolites on cardiovascular disease risk in overweight adult subjects upon the consumption of pomegranate extract.
The investigators hypothesis is that chronic consumption of a ellagitannin-rich source such as pomegranate extract could decrease serum oxidized-LDL as well as other inflammatory markers. The correlation between the effect exerted and the subjects' microbiota (capacity to produce the ellagitannin-derived metabolites urolithins) will indicate a possible role of urolithins on the effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pomegranate extract | Experimental | Crossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo. Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks. |
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| Placebo | Placebo Comparator | Crossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo. Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomegranate extract-first dose-Group A | Dietary Supplement | Group A will consume 1 daily capsule of pomegranate extract for 3 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in serum oxidized LDL-cholesterol concentration | Effect on circulating levels of oxidized particles of LDL-cholesterol | Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum lipids and lipoproteins levels | Effects on serum total cholesterol, LDL-cholesterol, HDL-cholesterol and apolipoproteins A1 (ApoA1), B (ApoB) and E (ApoE). | Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks |
| Change in serum sICAM, sVCAM and hsCRP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Juan Carlos EspÃn, PhD | National Research Council (CEBAS-CSIC, Murcia, Spain) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCAM (San Antonio Catholic University from Murcia) | Murcia | Murcia | 30107 | Spain |
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| Placebo-first dose-Group B | Dietary Supplement | Group B will consume 1 daily capsules of placebo for 3 weeks. |
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| Pomegranate extract-first dose-Group B | Dietary Supplement | After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks. |
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| Placebo-first dose-Group A | Dietary Supplement | After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks. |
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| Pomegranate extract-second dose-Group A | Dietary Supplement | After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks. |
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| Placebo-second dose-Group B | Dietary Supplement | After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks. |
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| Pomegranate extract-second dose-Group B | Dietary Supplement | After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks. |
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| Placebo-second dose-Group A | Dietary Supplement | After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks. |
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Effect on soluble intercellular adhesion molecule (sICAM), soluble vascular adhesion molecule (sVCAM) and high-sensitivity C-reactive protein (hsCRP) |
| Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks |
| Change in fecal microbiota | Prebiotic effect: Change in short fatty acids, bifidobacteria, lactobacilli and other selected species in feces | Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks |
| Number of volunteers with adverse events as a measure of safety and tolerability |
| Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks |
| Change in phenolics and derived metabolites in plasma, feces and urine. | Dose-response effect of pomegranate intake on phenolics and gut-microbiota derived metabolites in plasma, feces and urine. | Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks |
| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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