Non-inferiority Bioavailabilty Study of 3 Silicon-rich Supplements

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Randomized, Crossover, Double Blinded, Non-inferiority Study of Three Products Rich in Organic Silicon, in Postprandrial Situation

Conditions
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Absorption; Disorder

Intervention / Treatment
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* Dietary Supplement: Prod1
* Dietary Supplement: Prod2
* Dietary Supplement: Prod3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults men or women (>18 years old) With normal serum creatinine levels. Written informed consent provided before the initial screening visit. Exclusion Criteria: Suffering from chronic diseases Suffering from intestinal disorders Consuming silicon supplements in the 7 days prior to inclusion in the study. Consuming medicines containing silicon in the 7 days prior to inclusion in the study. Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study. Failing to follow study guidelines.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prod1<br>G5 Siliplant | Dietary Supplement: Prod1<br>* 60 mL of product (water, silicic acid, Equisetum Arvense, Rosmarinus officinalis) (Silicic acid) equivalent to 21.6 mg of elemental silicon.<br>* Other names: G5;|
| Experimental: Prod2<br>Orgono Powder® | Dietary Supplement: Prod2<br>* 1.4 g of product (Orthosalicic acid) equivalent to 21.6 mg of elemental silicon<br>* Other names: Orgono powder;|
| Experimental: Prod3<br>G7 ALOE | Dietary Supplement: Prod3<br>* 120 mL of product (Aloe barbadensis Miller, organic silicon, potassium sorbate, cítric acid) (Organic silicon) equivalent to 21.6 mg of elemental silicon<br>* Other names: G7 Aloe;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 |