Absorption; DisorderBIOSILICINCT03108508
Non-inferiority Bioavailabilty Study of 3 Silicon-rich Supplements
A study testing Prod1, Prod2 and Prod3 in people with Absorption; Disorder, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.
Trial summary
The objective of the present study is to evaluate the non-inferiority of the absorption parameters of three silicon supplements in human volunteers. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Absorption; Disorder
- What is being tested?
- Prod1, Prod2 and Prod3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2017to 30 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults men or women (>18 years old)
- With normal serum creatinine levels.
- Written informed consent provided before the initial screening visit.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Technological Centre of Nutrition and Health (CTNS)
Reus, Tarragona, 43204
About this study
Official title: Randomized, Crossover, Double Blinded, Non-inferiority Study of Three Products Rich in Organic Silicon, in Postprandrial Situation
The objective of the present study is to evaluate the non-inferiority of the absorption parameters of three silicon supplements in human volunteers.
Read the 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.
- Conditions
- Absorption; Disorder
- Being tested
- Prod1, Prod2, Prod3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prod1Dietary supplement
Also called G5
60 mL of product (water, silicic acid, Equisetum Arvense, Rosmarinus officinalis) (Silicic acid) equivalent to 21.6 mg of elemental silicon.
Prod2Dietary supplement
Also called Orgono powder
1.4 g of product (Orthosalicic acid) equivalent to 21.6 mg of elemental silicon
Prod3Dietary supplement
Also called G7 Aloe
120 mL of product (Aloe barbadensis Miller, organic silicon, potassium sorbate, cítric acid) (Organic silicon) equivalent to 21.6 mg of elemental silicon
| Study group | Role | What they receive |
|---|---|---|
| Prod1 | Experimental | G5 Siliplant Receives: Dietary Supplement: Prod1 |
| Prod2 | Experimental | Orgono Powder® Receives: Dietary Supplement: Prod2 |
| Prod3 | Experimental | G7 ALOE Receives: Dietary Supplement: Prod3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of sillicium in urine samples
concentration of sillicium in urine samples will be measured by inductively coupled plasma optical emission spectrometry.
Measured: 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
concentration of silicon in blood/plasma samples will be measured by inductively coupled plasma optical emission spectrometry.
.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 May 2017
- Primary completion30 Jun 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Absorption; DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technological Centre of Nutrition and Health, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- SILICIUM ESPAÑA LABORATORIOS SLU, Hospital Universitari Sant Joan de Reus, University Rovira i Virgili
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108508
- Sponsor's protocol ID
- BIOSILICI
- Acronym
- BIOSILICI
- Status last verified
- Jul 2020
- First submitted
- 29 Mar 2017
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Crossover, Double Blinded, Non-inferiority Study of Three Products Rich in Organic Silicon, in Postprandrial Situation
- ClinicalTrials.gov ID
- NCT03108508
- Acronym / sponsor ID
- BIOSILICI / BIOSILICI
- Conditions
- Absorption; Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Technological Centre of Nutrition and Health, SpainUniversity, hospital or other
- Collaborators
- SILICIUM ESPAÑA LABORATORIOS SLU, Hospital Universitari Sant Joan de Reus, University Rovira i Virgili
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prod1 | Experimental | Dietary Supplement: Prod1G5 Siliplant |
| Prod2 | Experimental | Dietary Supplement: Prod2Orgono Powder® |
| Prod3 | Experimental | Dietary Supplement: Prod3G7 ALOE |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults men or women (>18 years old)
- With normal serum creatinine levels.
- Written informed consent provided before the initial screening visit.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prod1Also: G560 mL of product (water, silicic acid, Equisetum Arvense, Rosmarinus officinalis) (Silicic acid) equivalent to 21.6 mg of elemental silicon. | Dietary supplement | Prod1 |
| Prod2Also: Orgono powder1.4 g of product (Orthosalicic acid) equivalent to 21.6 mg of elemental silicon | Dietary supplement | Prod2 |
| Prod3Also: G7 Aloe120 mL of product (Aloe barbadensis Miller, organic silicon, potassium sorbate, cítric acid) (Organic silicon) equivalent to 21.6 mg of elemental silicon | Dietary supplement | Prod3 |
Primary outcome
concentration of sillicium in urine samples
Time frame: 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.
1 secondary outcome
concentration of sillicium in plasma
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Technological Centre of Nutrition and HealthLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prod1, Prod2 and Prod3 in people with Absorption; Disorder, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of sillicium in urine samples (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.