Non-inferiority Bioavailabilty Study of 3 Silicon-rich Supplements

NCT ID: NCT03108508

Last Updated: 2020-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2017-07-30

Brief Summary

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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

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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.

Conditions

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Absorption; Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Prod1

G5 Siliplant

Group Type EXPERIMENTAL

Prod1

Intervention Type DIETARY_SUPPLEMENT

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

Prod2

Orgono Powder®

Group Type EXPERIMENTAL

Prod2

Intervention Type DIETARY_SUPPLEMENT

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

Prod3

G7 ALOE

Group Type EXPERIMENTAL

Prod3

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Prod1

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

Intervention Type DIETARY_SUPPLEMENT

Prod2

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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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G5 Orgono powder G7 Aloe

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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SILICIUM ESPAÑA LABORATORIOS SLU

UNKNOWN

Sponsor Role collaborator

Hospital Universitari Sant Joan de Reus

OTHER

Sponsor Role collaborator

University Rovira i Virgili

OTHER

Sponsor Role collaborator

Technological Centre of Nutrition and Health, Spain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Technological Centre of Nutrition and Health (CTNS)

Reus, Tarragona, Spain

Site Status

Countries

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Spain

Related Links

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http://www.ctns.cat/en

Technological Centre of Nutrition and Health

Other Identifiers

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BIOSILICI

Identifier Type: -

Identifier Source: org_study_id

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