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
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2017
CompletedFirst Posted
Study publicly available on registry
April 11, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2017
CompletedJuly 20, 2020
July 1, 2020
2 months
March 29, 2017
July 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (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
Study Arms (3)
Prod1
EXPERIMENTALG5 Siliplant
Prod2
EXPERIMENTALOrgono Powder®
Prod3
EXPERIMENTALG7 ALOE
Interventions
60 mL of product (water, silicic acid, Equisetum Arvense, Rosmarinus officinalis) (Silicic acid) equivalent to 21.6 mg of elemental silicon.
1.4 g of product (Orthosalicic acid) equivalent to 21.6 mg of elemental silicon
120 mL of product (Aloe barbadensis Miller, organic silicon, potassium sorbate, cítric acid) (Organic silicon) equivalent to 21.6 mg of elemental silicon
Eligibility Criteria
You may qualify if:
- Adults men or women (\>18 years old)
- With normal serum creatinine levels.
- Written informed consent provided before the initial screening visit.
You may not qualify if:
- Suffering from chronic diseases
- Suffering from intestinal disorders
- Failing to follow study guidelines.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Technological Centre of Nutrition and Health, Spainlead
- SILICIUM ESPAÑA LABORATORIOS SLUcollaborator
- Hospital Universitari Sant Joan de Reuscollaborator
- University Rovira i Virgilicollaborator
Study Sites (1)
Technological Centre of Nutrition and Health (CTNS)
Reus, Tarragona, 43204, Spain
Related Links
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2017
First Posted
April 11, 2017
Study Start
May 1, 2017
Primary Completion
June 30, 2017
Study Completion
July 30, 2017
Last Updated
July 20, 2020
Record last verified: 2020-07