Non-inferiority Bioavailabilty Study of 3 Silicon-rich Supplements

Technological Centre of Nutrition and Health, Spain5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Absorption; Disorder

Interventions

Prod1DIETARY_SUPPLEMENT

60 mL of product (water, silicic acid, Equisetum Arvense, Rosmarinus officinalis) (Silicic acid) equivalent to 21.6 mg of elemental silicon.

Prod2DIETARY_SUPPLEMENT

1.4 g of product (Orthosalicic acid) equivalent to 21.6 mg of elemental silicon

Prod3DIETARY_SUPPLEMENT

120 mL of product (Aloe barbadensis Miller, organic silicon, potassium sorbate, cítric acid) (Organic silicon) equivalent to 21.6 mg of elemental silicon

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Technological Centre of Nutrition and Health (CTNS)

Reus, Tarragona, Spain

Outcomes

Primary Outcomes

concentration of sillicium in urine samples

concentration of sillicium in urine samples will be measured by inductively coupled plasma optical emission spectrometry.

Time frame: 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 Outcomes

concentration of sillicium in plasma

concentration of silicon in blood/plasma samples will be measured by inductively coupled plasma optical emission spectrometry. .

Time frame: 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

Data from ClinicalTrials.gov

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