Non-inferiority Bioavailabilty Study of 3 Silicon-rich Supplements

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03108508

Acronym

BIOSILICI

Enrollment

Registered

2017-04-11

Start date

2017-05-01

Completion date

2017-07-30

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Absorption; Disorder

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTProd1

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

DIETARY_SUPPLEMENTProd2

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

DIETARY_SUPPLEMENTProd3

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
concentration of sillicium in urine samples	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)	concentration of sillicium in urine samples will be measured by inductively coupled plasma optical emission spectrometry.

Secondary

Measure	Time frame	Description
concentration of sillicium in plasma	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	concentration of silicon in blood/plasma samples will be measured by inductively coupled plasma optical emission spectrometry. .

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026