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BIOSILICI: Non-inferiority Bioavailabilty Study of 3 Silicon-rich Supplements

Sponsor
Technological Centre of Nutrition and Health, Spain (Other)
Overall Status
Completed
CT.gov ID
NCT03108508
Collaborator
SILICIUM ESPAÑA LABORATORIOS SLU (Other), Hospital Universitari Sant Joan de Reus (Other), University Rovira i Virgili (Other)
5
Enrollment
1
Location
3
Arms
3
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Prod1
  • Dietary Supplement: Prod2
  • Dietary Supplement: Prod3
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Randomized, Crossover, Double Blinded, Non-inferiority Study of Three Products Rich in Organic Silicon, in Postprandrial Situation
Actual Study Start Date :
May 1, 2017
Actual Primary Completion Date :
Jun 30, 2017
Actual Study Completion Date :
Jul 30, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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. .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Technological Centre of Nutrition and Health (CTNS) Reus Tarragona Spain 43204

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Technological Centre of Nutrition and Health, Spain
    ClinicalTrials.gov Identifier:
    NCT03108508
    Other Study ID Numbers:
    • BIOSILICI
    First Posted:
    Apr 11, 2017
    Last Update Posted:
    Jul 20, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 20, 2020