Non-inferiority Bioavailabilty Study of 3 Silicon-rich Supplements

Not Applicable

Completed

• Conditions: Absorption; Disorder
• Interventions: Dietary Supplement: Prod1; Dietary Supplement: Prod2; Dietary Supplement: Prod3

• Registration Number: NCT03108508
• Lead Sponsor: Technological Centre of Nutrition and Health, Spain

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.

Study Timeline

• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Study Start: 2017-05-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-07-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Prod1	Prod1	G5 Siliplant
Prod2	Prod2	Orgono Powder®
Prod3	Prod3	G7 ALOE

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.; .

Trial Locations

Locations (1)

Technological Centre of Nutrition and Health (CTNS); 🇪🇸 Reus, Tarragona, Spain