Non-inferiority Bioavailabilty Study of 3 Silicon-rich Supplements

Absorption; Disorder Clinical Trial

— BIOSILICI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03108508
• Other study ID #: BIOSILICI
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Absorption; Disorder

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

External Links

•   Technological Centre of Nutrition and Health