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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03108508
Other study ID # BIOSILICI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date July 30, 2017

Study information

Verified date July 2020
Source Technological Centre of Nutrition and Health, Spain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the present study is to evaluate the non-inferiority of the absorption parameters of three silicon supplements in human volunteers.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date July 30, 2017
Est. primary completion date June 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Prod1
60 mL of product (water, silicic acid, Equisetum Arvense, Rosmarinus officinalis) (Silicic acid) equivalent to 21.6 mg of elemental silicon.
Prod2
1.4 g of product (Orthosalicic acid) equivalent to 21.6 mg of elemental silicon
Prod3
120 mL of product (Aloe barbadensis Miller, organic silicon, potassium sorbate, cítric acid) (Organic silicon) equivalent to 21.6 mg of elemental silicon

Locations

Country Name City State
Spain Technological Centre of Nutrition and Health (CTNS) Reus Tarragona

Sponsors (4)

Lead Sponsor Collaborator
Technological Centre of Nutrition and Health, Spain Hospital Universitari Sant Joan de Reus, SILICIUM ESPAÑA LABORATORIOS SLU, University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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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