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| Name | Class |
|---|---|
| SILICIUM ESPAÑA LABORATORIOS SLU | UNKNOWN |
| Hospital Universitari Sant Joan de Reus | OTHER |
| University Rovira i Virgili | OTHER |
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The objective of the present study is to evaluate the non-inferiority of the absorption parameters of three silicon supplements in human volunteers.
The objective of the present study is to evaluate the non-inferiority of the absorption parameters of three silicon supplements in human volunteers.
Participants: 5 healthy men over 18 years old, with normal serum creatinine levels. Treatment consists of one product consumption every week, and measuring postprandrial response at 0, 30, 60, 90, 120, 180, 240 and 360 min, in blood, and urine in two periods of three hours each.
The statistical analysis will follow the principles specified in the guidelines of the ICHE and CPMP/EWP/908/99 ICHE Points to Consider on Multiplicity Issues in Clinical Trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prod1 | Experimental | G5 Siliplant |
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| Prod2 | Experimental | Orgono Powder® |
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| Prod3 | Experimental | G7 ALOE |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prod1 | Dietary Supplement | 60 mL of product (water, silicic acid, Equisetum Arvense, Rosmarinus officinalis) (Silicic acid) equivalent to 21.6 mg of elemental silicon. |
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| Measure | Description | Time Frame |
|---|---|---|
| concentration of sillicium in urine samples | concentration of sillicium in urine samples will be measured by inductively coupled plasma optical emission spectrometry. | Urine will be collected in two 3-h collections (0-180min and 181-360 min) in two separate containers at Visit 1, Visit 2 and Visit 3 (1 week between visits) |
| Measure | Description | Time Frame |
|---|---|---|
| concentration of sillicium in plasma | concentration of silicon in blood/plasma samples will be measured by inductively coupled plasma optical emission spectrometry. . | Blood samples will be collected to determine baseline plasma silicon value (time 0 min = T0). After ingestion of one of the study products, additional blood samples will be collected at 30, 60, 90 and 120 min at Visit 1, Visit 2 and Visit 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Technological Centre of Nutrition and Health (CTNS) | Reus | Tarragona | 43204 | Spain |
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| Label | URL |
|---|---|
| Technological Centre of Nutrition and Health | View source |
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| Prod2 | Dietary Supplement | 1.4 g of product (Orthosalicic acid) equivalent to 21.6 mg of elemental silicon |
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| Prod3 | Dietary Supplement | 120 mL of product (Aloe barbadensis Miller, organic silicon, potassium sorbate, cítric acid) (Organic silicon) equivalent to 21.6 mg of elemental silicon |
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