Non-inferiority Bioavailabilty Study of 3 Silicon-rich Supplements (BIOSILICI)

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

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

Study Overview

• Status: Completed
• Conditions: Absorption; Disorder
• Intervention / Treatment: Dietary supplement: Prod1; Dietary supplement: Prod2; Dietary supplement: Prod3

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain, 43204
      • Technological Centre of Nutrition and Health (CTNS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Technological Centre of Nutrition and Health, Spain
• Collaborators: University Rovira i Virgili; Hospital Universitari Sant Joan de Reus; SILICIUM ESPAÑA LABORATORIOS SLU

Publications and helpful links

Helpful Links

• Technological Centre of Nutrition and Health

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): July 30, 2017

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BIOSILICI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No