Aluminium OverloadSILIALNCT05116982
Effect of Three Silicon Based Food Supplements on the Urinary Excretion of Aluminum and Other Metals (SILIAL)
A study testing ORGONO Living Silica Acacia Gum-MMST Powder, ORGONO Living Silica Malto-OSA Powder and ORGONO Living Silica Collagen Booster in people with Aluminium Overload and Biological Availability, run by Fundació Eurecat at 2 sites in Spain.
Trial summary
Aluminum is a very abundant element in nature. Humans are exposed to this metal through the environment, diet, and drinking water, as well as through the consumption of certain medications. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aluminium Overload, Biological Availability
- What is being tested?
- ORGONO Living Silica Acacia Gum-MMST Powder, ORGONO Living Silica Malto-OSA Powder and ORGONO Living Silica Collagen Booster
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 2 sitesSpain
- Study dates
- 9 May 2022to 12 Jun 2022
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 40 to 65.
- Individuals with normal serum creatinine levels: up to 1.1 mg/dl in women and up to 1.4 mg/dl in men.
Who cannot join
- Individuals taking any type of medication and/or supplement containing aluminum, including antacids.
- Individuals who take food supplements and/or medication that contains mercury, nickel, arsenic, cadmium, iron, copper, and silicon.
- Individuals who eat mineral-enriched foods.
- Individuals allergic to any component of the dietary supplements of the study.
- Individuals with urge, stress or mixed urinary incontinence. Involuntary loss of urine accompanied by symptoms of both urge or stress urinary incontinence diagnosed by your primary care physician. In case of absence of diagnosis, the IU-4 questionnaire will be carried out.
- Pregnancy or breastfeeding.
Show all 15Show fewer
- Individuals with any chronic gastrointestinal disease.
- Individuals with chronic kidney disease (or serum creatinine levels ≥ 1.7 mg/dl in men and ≥ 1.5 mg/dl in women).
- Be participating or have participated in a clinical trial or study of nutritional intervention in the last 30 days before study inclusion.
- Being a smoker.
- Consume 2 or more Standard Beverage Units daily or 17 weekly in women, or consume 4 or more Standard Beverage Units daily or 28 weekly in mens.
- Individuals whose condition does not allow them to carry out the study procedures strictly.
- Individuals with diseases with manifest symptoms that may influence the objectives of the study.
- Individuals with BMI≥ 30 kg/m^2.
- Individuals whose consumption of foods rich in silicon, aluminum, mercury, nickel, arsenic, cadmium, iron and copper are high.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Grupo de investigación de nutrición, estrés oxidativo y biodisponibilidad. Universidad Católica de Murcia (UCAM)
Guadalupe, Murcia, 30107
Eurecat
Reus, 43204
About this study
Official title: Interventional Study to Evaluate the Effect of Three Silicon Based Food Supplements on the Urinary Excretion of Aluminum and Other Metals. Randomized, Parallel, Controlled and Double Blind Study (SILIAL)
Aluminum is a very abundant element in nature. Humans are exposed to this metal through the environment, diet, and drinking water, as well as through the consumption of certain medications.
Aluminum is not an essential element for human, being able to become neurotoxic when it reaches the brain once ingested at very high doses and, above all, if there is also kidney dysfunction.
Read more
Silicon is one of the most abundant elements on the planet and although it is not considered an essential element for humans, some beneficial activities have been documented.
Silicon has been found to be readily available in food and that 41% of ingested silicon is excreted in the urine, with a significant correlation between silicon ingested with food and urinary silicon excretion.
The most bioavailable silicon is that found in the form of silicic acid or orthosilicic acid.
Numerous studies suggest that silicon can reduce the oral absorption of aluminum and / or improve its excretion and, therefore, protect against the adverse effects induced by the ingestion of aluminum.
In a clinical study with healthy individuals as a control group for Alzheimer's disease, the levels of aluminum excretion were analyzed after the continuous ingestion of water enriched in silicon. The results in the first urine of the morning during the first week of ingestion of the enriched water showed that the excretion of aluminum was 136.9 ± 81.4 µmol / nmol creatinine while in the baseline week it was lower, 98.8 ± 64.3 nmol / nmol creatinine. These results indicated that the Al excreted came from Al stored in the body.
The main objective of the study is to evaluate the effect of the consumption of three food supplements formulated with different silicon compounds (monomethylsilanetriol and / or silicic acid) on the urinary excretion of aluminum.
The secondary objectives of the study are to evaluate:
- the bioavailability of the silicon contained in three food supplements formulated with different silicon compounds.
- the effect of the consumption of three food supplements formulated with different silicon compounds on urinary excretion of mercury, nickel, arsenic, cadmium, iron and copper.
- the safety of the consumption of three food supplements formulated with different silicon compounds.
Read the detailed description
It will be conducted a single-center, randomized, controlled, double-blind clinical trial with four groups in parallel (placebo, Supplement A, Supplement B and Supplement C).
The study will be carried out with a total of 40 individuals (10 individuals per group), men and women aged 40 to 65 years. Individuals will have normal serum creatinine levels: up to 1.1mg/dl in women and up to 1.4mg/dl in men.
The investigational products involved in this study are four food supplements made from silicon compounds and the corresponding placebos.
Each participant will receive a kit containing a bottle with 10 capsules and a bottle of 100 ml of liquid according to the treatments corresponding to the randomly assigned group.
During the study, the volunteers will consume one capsule and 100ml of product each day for 7 days. The first morning urine will be collected during the 7 days of treatment and also during the previous 7 days to analyze the baseline values. In addition, on days 6 and 7 of the study, the urine will be collected in three fractions up to 24h to evaluate the bioavailability of silicon.
Participants will make a total of 5 visits, including the pre-selection visit. In these visits, the following will be carried out: Revision of Inclusion and exclusion criteria; Informed consent signature;Safety biochemistry; Demographic variables (age, sex), anthropometric variables; Evaluation of dietary intake; Randomization; Delivery of the sampling material; Verification of compliance with dietary requirements; Collection of urine samples; Investigation product delivery; Determination of metals in urine; Registration of Medication and food supplements; concomitants adverse event registry.
- Conditions
- Aluminium Overload, Biological Availability
- Being tested
- ORGONO Living Silica Acacia Gum-MMST Powder, ORGONO Living Silica Malto-OSA Powder, ORGONO Living Silica Collagen Booster, Placebo
- Keywords
- Silicon, Aluminum, urinary excretion, Food supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORGONO Living Silica Acacia Gum-MMST PowderDietary supplement
Participants will consume one capsule per day and one bottle per day. Capsule composition: Acacia Gum 336.1 mg/capsule; Monomethylsilanetriol 34.9 mg/capsule; Hydroxypropyl methylcellulose 95 mg/capsule. Bottle composition: water 100 ml. Silicon content per dose: 10.4 mg.
ORGONO Living Silica Malto-OSA PowderDietary supplement
Participants will consume one capsule per day and one bottle per day. Capsule composition: Maltodextrin 311.4 mg/capsule; Silicic acid 35.6 mg/capsule; Hydroxypropyl methylcellulose 95 mg/capsule. Bottle composition: water 100 ml. Silicon content per dose: 10.4 mg.
ORGONO Living Silica Collagen BoosterDietary supplement
Participants will consume one capsule per day and one bottle per day. Capsule composition: Hydroxypropyl methylcellulose 320 mg/capsule. Bottle composition: water 99.9646 g/100 ml; Silicic acid 23.65 mg/100 ml; Monomethylsilanetriol 11.75 mg/100 ml. Silicon content per dose: 10.4 mg.
PlaceboDietary supplement
Participants will consume one capsule per day and one bottle per day. Capsule composition: Hydroxypropyl methylcellulose 320 mg/capsule. Bottle composition: water 100 ml.
| Study group | Role | What they receive |
|---|---|---|
| ORGONO Living Silica Acacia Gum-MMST Powder | Experimental | ORGONO Living Silica Acacia gum-MMST Power. In capsules. One capsule a day for 7 days. Receives: Dietary Supplement: ORGONO Living Silica Acacia Gum-MMST Powder |
| ORGONO Living Silica Malto-OSA Powder | Experimental | ORGONO Living Silica Malto-OSA Powder. In capsules. One capsule a day for 7 days. Receives: Dietary Supplement: ORGONO Living Silica Malto-OSA Powder |
| ORGONO Living Silica Collagen Booster | Experimental | ORGONO Living Silica Collagen Booster. Liquid. One bottle a day for 7 days. Receives: Dietary Supplement: ORGONO Living Silica Collagen Booster |
| Placebo | Placebo comparator | Placebo. In capsules and liquid. One capsule and one bottle a day for 7 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary excretion of aluminum
Aluminum levels in the first morning urine will be determined before consuming the dietary supplement every day for 6 days and after consuming the dietary supplement every day for 6 days. Furthermore, at days 6th and 7th urinary aluminum levels will be determined in three fractions of time (8:30-11:30 hours; 11:30h-14:30 hours; 14:30-24 hours) before and after consumption of the dietary supplement, respectively. Urinary excretion of aluminium will be calculated by means of the average excreted levels of aluminium in urine for 7 days and considering the difference between the levels excreted in urine before and after the consumption of each silicon supplement.
Aluminum levels in urine will be quantified by Inductively Coupled Plasma-Optical Emission Spectrometry and will be expressed by mmol of excreted creatinine.
Measured: 7 days
Secondary outcomes (10)
Bioavailability of silicon
The bioavailability of silicon will be calculated by urine silicon concentration. Silicon levels will be determined in three fractions of time (8:30-11:30 hours; 11:30-14:30 hours; 14:30-24 hours) before and after consumption of the dietary supplement. Silicon bioavailability will be calculated by the difference in the sum of silicon levels in all urine fractions before and after consumption of each silicon supplement. Silicon levels in urine will be measured by Inductively Coupled Plasma-Optical Emission Spectrometry and will be expressed by volume of urine.
Measured: 24 hours
Urinary excretion of mercury
Mercury levels in the first morning urine will be determined before consuming the dietary supplement every day for 6 days and after consuming the dietary supplement every day for 6 days. Furthermore, at days 6th and 7th urinary mercury levels will be determined in three fractions of time (8:30-11:30 hours; 11:30h-14:30 hours; 14:30-24 hours) before and after consumption of the dietary supplement, respectively. Urinary excretion of mercury will be calculated by means of the average excreted levels of mercury in urine for 7 days and considering the difference between the levels excreted in urine before and after the consumption of each silicon supplement.
Mercury levels in urine will be quantified by Inductively Coupled Plasma-Optical Emission Spectrometry and will be expressed by mmol of excreted creatinine.
Measured: 7 days
Urinary excretion of nickel
Nickel levels in the first morning urine will be determined before consuming the dietary supplement every day for 6 days and after consuming the dietary supplement every day for 6 days. Furthermore, at days 6th and 7th urinary nickel levels will be determined in three fractions of time (8:30-11:30 hours; 11:30h-14:30 hours; 14:30-24 hours) before and after consumption of the dietary supplement, respectively. Urinary excretion of nickel will be calculated by means of the average excreted levels of nickel in urine for 7 days and considering the difference between the levels excreted in urine before and after the consumption of each silicon supplement.
Nickel levels in urine will be quantified by Inductively Coupled Plasma-Optical Emission Spectrometry and will be expressed by mmol of excreted creatinine.
Measured: 7 days
Urinary excretion of arsenic
Arsenic levels in the first morning urine will be determined before consuming the dietary supplement every day for 6 days and after consuming the dietary supplement every day for 6 days. Furthermore, at days 6th and 7th urinary arsenic levels will be determined in three fractions of time (8:30-11:30 hours; 11:30h-14:30 hours; 14:30-24 hours) before and after consumption of the dietary supplement, respectively. Urinary excretion of arsenic will be calculated by means of the average excreted levels of arsenic in urine for 7 days and considering the difference between the levels excreted in urine before and after the consumption of each silicon supplement.
Arsenic levels in urine will be quantified by Inductively Coupled Plasma-Optical Emission Spectrometry and will be expressed by mmol of excreted creatinine.
Measured: 7 days
Urinary excretion of cadmium
Cadmium levels in the first morning urine will be determined before consuming the dietary supplement every day for 6 days and after consuming the dietary supplement every day for 6 days. Furthermore, at days 6th and 7th urinary cadmium levels will be determined in three fractions of time (8:30-11:30 hours; 11:30h-14:30 hours; 14:30-24 hours) before and after consumption of the dietary supplement, respectively. Urinary excretion of cadmium will be calculated by means of the average excreted levels of cadmium in urine for 7 days and considering the difference between the levels excreted in urine before and after the consumption of each silicon supplement.
Cadmium levels in urine will be quantified by Inductively Coupled Plasma-Optical Emission Spectrometry and will be expressed by mmol of excreted creatinine.
Measured: 7 days
Urinary excretion of iron
Iron levels in the first morning urine will be determined before consuming the dietary supplement every day for 6 days and after consuming the dietary supplement every day for 6 days. Furthermore, at days 6th and 7th urinary iron levels will be determined in three fractions of time (8:30-11:30 hours; 11:30h-14:30 hours; 14:30-24 hours) before and after consumption of the dietary supplement, respectively. Urinary excretion of iron will be calculated by means of the average excreted levels of iron in urine for 7 days and considering the difference between the levels excreted in urine before and after the consumption of each silicon supplement.
Iron levels in urine will be quantified by Inductively Coupled Plasma-Optical Emission Spectrometry and will be expressed by mmol of excreted creatinine.
Measured: 7 days
Urinary excretion of copper
Copper levels in the first morning urine will be determined before consuming the dietary supplement every day for 6 days and after consuming the dietary supplement every day for 6 days. Furthermore, at days 6th and 7th urinary copper levels will be determined in three fractions of time (8:30-11:30 hours; 11:30h-14:30 hours; 14:30-24 hours) before and after consumption of the dietary supplement, respectively. Urinary excretion of copper will be calculated by means of the average excreted levels of copper in urine for 7 days and considering the difference between the levels excreted in urine before and after the consumption of each silicon supplement.
Copper levels in urine will be quantified by Inductively Coupled Plasma-Optical Emission Spectrometry and will be expressed by mmol of excreted creatinine.
Measured: 7 days
Urinary levels of creatinine
Creatinine levels in the first morning urine will be determined before consuming the dietary supplement every day for 6 days and after consuming the dietary supplement every day for 6 days. Furthermore, at days 6th and 7th urinary creatinine levels will be determined in three fractions of time (8:30-11:30 hours; 11:30h-14:30 hours; 14:30-24 hours) before and after consumption of the dietary supplement, respectively.
Creatinine levels in urine will be quantified by a colorimetric kit.
Measured: 14 days
Security
The safety of the dietary supplements will be evaluated through the analysis of renal markers (urea and creatinine), liver markers (transaminases) and blood count at pre-selection visit and after the consumption of the silicon supplement for 7 days. To measure the security of each silicon supplement, results obtained after each silicon supplement ingestion will be compared with results obtained before its consumption.
Measured: 7 days
Adverse events
Adverse events will be recorded throughout the study from the initial visit to the final visit.
Measured: Every day for 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start9 May 2022
- Primary completion12 Jun 2022
- Study completion12 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aluminium OverloadStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Eurecat
- Sponsor type
- University, hospital or other
- Collaborators
- Silicium Laboratories S.L., San Antonio Technologies S.L., Catholic University of Murcia, Zaidin Experimental Station, Spanish Council for Scientific Research (CSIC) Agency
- Responsible party
- Sponsor
- Investigators
- Josep M Del Bas, PhD, Study director, UTNS (Eurecat-Reus)Pilar Zafrilla, PhD, Principal investigator, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116982
- Sponsor's protocol ID
- SAT-EURECAT-01-20
- Acronym
- SILIAL
- Status last verified
- Sep 2022
- First submitted
- 8 Oct 2021
- Last updated
- 16 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study to Evaluate the Effect of Three Silicon Based Food Supplements on the Urinary Excretion of Aluminum and Other Metals. Randomized, Parallel, Controlled and Double Blind Study (SILIAL)
- ClinicalTrials.gov ID
- NCT05116982
- Acronym / sponsor ID
- SILIAL / SAT-EURECAT-01-20
- Conditions
- Aluminium Overload, Biological Availability
- Keywords
- Silicon, Aluminum, urinary excretion, Food supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Fundació EurecatUniversity, hospital or other
- Collaborators
- Silicium Laboratories S.L., San Antonio Technologies S.L., Catholic University of Murcia, Zaidin Experimental Station, Spanish Council for Scientific Research (CSIC) Agency
- Study start
- 9 May 2022 (actual)
- Primary completion
- 12 Jun 2022 (actual)
- Study completion
- 12 Jun 2022 (actual)
- First posted
- 11 Nov 2021 (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.
Aluminum is a very abundant element in nature. Humans are exposed to this metal through the environment, diet, and drinking water, as well as through the consumption of certain medications.
Aluminum is not an essential element for human, being able to become neurotoxic when it reaches the brain once ingested at very high doses and, above all, if there is also kidney dysfunction.
Silicon is one of the most abundant elements on the planet and although it is not considered an essential element for humans, some beneficial activities have been documented.
Silicon has been found to be readily available in food and that 41% of ingested silicon is excreted in the urine, with a significant correlation between silicon ingested with food and urinary silicon excretion.
The most bioavailable silicon is that found in the form of silicic acid or orthosilicic acid.
Numerous studies suggest that silicon can reduce the oral absorption of aluminum and / or improve its excretion and, therefore, protect against the adverse effects induced by the ingestion of aluminum.
In a clinical study with healthy individuals as a control group for Alzheimer's disease, the levels of aluminum excretion were analyzed after the continuous ingestion of water enriched in silicon. The results in the first urine of the morning during the first week of ingestion of the enriched water showed that the excretion of aluminum was 136.9 ± 81.4 µmol / nmol creatinine while in the baseline week it was lower, 98.8 ± 64.3 nmol / nmol creatinine. These results indicated that the Al excreted came from Al stored in the body.
The main objective of the study is to evaluate the effect of the consumption of three food supplements formulated with different silicon compounds (monomethylsilanetriol and / or silicic acid) on the urinary excretion of aluminum.
The secondary objectives of the study are to evaluate:
- the bioavailability of the silicon contained in three food supplements formulated with different silicon compounds.
- the effect of the consumption of three food supplements formulated with different silicon compounds on urinary excretion of mercury, nickel, arsenic, cadmium, iron and copper.
- the safety of the consumption of three food supplements formulated with different silicon compounds.
Detailed description
It will be conducted a single-center, randomized, controlled, double-blind clinical trial with four groups in parallel (placebo, Supplement A, Supplement B and Supplement C).
The study will be carried out with a total of 40 individuals (10 individuals per group), men and women aged 40 to 65 years. Individuals will have normal serum creatinine levels: up to 1.1mg/dl in women and up to 1.4mg/dl in men.
The investigational products involved in this study are four food supplements made from silicon compounds and the corresponding placebos.
Each participant will receive a kit containing a bottle with 10 capsules and a bottle of 100 ml of liquid according to the treatments corresponding to the randomly assigned group.
During the study, the volunteers will consume one capsule and 100ml of product each day for 7 days. The first morning urine will be collected during the 7 days of treatment and also during the previous 7 days to analyze the baseline values. In addition, on days 6 and 7 of the study, the urine will be collected in three fractions up to 24h to evaluate the bioavailability of silicon.
Participants will make a total of 5 visits, including the pre-selection visit. In these visits, the following will be carried out: Revision of Inclusion and exclusion criteria; Informed consent signature;Safety biochemistry; Demographic variables (age, sex), anthropometric variables; Evaluation of dietary intake; Randomization; Delivery of the sampling material; Verification of compliance with dietary requirements; Collection of urine samples; Investigation product delivery; Determination of metals in urine; Registration of Medication and food supplements; concomitants adverse event registry.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ORGONO Living Silica Acacia Gum-MMST Powder | Experimental | Dietary Supplement: ORGONO Living Silica Acacia Gum-MMST PowderORGONO Living Silica Acacia gum-MMST Power. In capsules. One capsule a day for 7 days. |
| ORGONO Living Silica Malto-OSA Powder | Experimental | Dietary Supplement: ORGONO Living Silica Malto-OSA PowderORGONO Living Silica Malto-OSA Powder. In capsules. One capsule a day for 7 days. |
| ORGONO Living Silica Collagen Booster | Experimental | Dietary Supplement: ORGONO Living Silica Collagen BoosterORGONO Living Silica Collagen Booster. Liquid. One bottle a day for 7 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo. In capsules and liquid. One capsule and one bottle a day for 7 days. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women aged 40 to 65.
- Individuals with normal serum creatinine levels: up to 1.1 mg/dl in women and up to 1.4 mg/dl in men.
Key exclusion criteria (15 listed)
- Individuals taking any type of medication and/or supplement containing aluminum, including antacids.
- Individuals who take food supplements and/or medication that contains mercury, nickel, arsenic, cadmium, iron, copper, and silicon.
- Individuals who eat mineral-enriched foods.
- Individuals allergic to any component of the dietary supplements of the study.
- Individuals with urge, stress or mixed urinary incontinence. Involuntary loss of urine accompanied by symptoms of both urge or stress urinary incontinence diagnosed by your primary care physician. In case of absence of diagnosis, the IU-4 questionnaire will be carried out.
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 |
|---|---|---|
| ORGONO Living Silica Acacia Gum-MMST PowderParticipants will consume one capsule per day and one bottle per day. Capsule composition: Acacia Gum 336.1 mg/capsule; Monomethylsilanetriol 34.9 mg/capsule; Hydroxypropyl methylcellulose 95 mg/capsule. Bottle composition: water 100 ml. Silicon content per dose: 10.4 mg. | Dietary supplement | ORGONO Living Silica Acacia Gum-MMST Powder |
| ORGONO Living Silica Malto-OSA PowderParticipants will consume one capsule per day and one bottle per day. Capsule composition: Maltodextrin 311.4 mg/capsule; Silicic acid 35.6 mg/capsule; Hydroxypropyl methylcellulose 95 mg/capsule. Bottle composition: water 100 ml. Silicon content per dose: 10.4 mg. | Dietary supplement | ORGONO Living Silica Malto-OSA Powder |
| ORGONO Living Silica Collagen BoosterParticipants will consume one capsule per day and one bottle per day. Capsule composition: Hydroxypropyl methylcellulose 320 mg/capsule. Bottle composition: water 99.9646 g/100 ml; Silicic acid 23.65 mg/100 ml; Monomethylsilanetriol 11.75 mg/100 ml. Silicon content per dose: 10.4 mg. | Dietary supplement | ORGONO Living Silica Collagen Booster |
| PlaceboParticipants will consume one capsule per day and one bottle per day. Capsule composition: Hydroxypropyl methylcellulose 320 mg/capsule. Bottle composition: water 100 ml. | Dietary supplement | Placebo |
Primary outcome
Urinary excretion of aluminum
Time frame: 7 days
Aluminum levels in the first morning urine will be determined before consuming the dietary supplement every day for 6 days and after consuming the dietary supplement every day for 6 days. Furthermore, at days 6th and 7th urinary aluminum levels will be determined in three fractions of time (8:30-11:30 hours; 11:30h-14:30 hours; 14:30-24 hours) before and after consumption of the dietary supplement, respectively. Urinary excretion of aluminium will be calculated by means of the average excreted levels of aluminium in urine for 7 days and considering the difference between the levels excreted in urine before and after the consumption of each silicon supplement. Aluminum levels in urine will be quantified by Inductively Coupled Plasma-Optical Emission Spectrometry and will be expressed by mmol of excreted creatinine.
10 secondary outcomes
Bioavailability of silicon
Time frame: 24 hours
Urinary excretion of mercury
Time frame: 7 days
Urinary excretion of nickel
Time frame: 7 days
Urinary excretion of arsenic
Time frame: 7 days
Urinary excretion of cadmium
Time frame: 7 days
Urinary excretion of iron
Time frame: 7 days
Urinary excretion of copper
Time frame: 7 days
Urinary levels of creatinine
Time frame: 14 days
Security
Time frame: 7 days
Adverse events
Time frame: Every day for 14 days
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 16 Sep 2022.
- Technological Centre of Nutrition and Health. Eurecat-Reus.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Josep M Del Bas, PhD study director
UTNS (Eurecat-Reus)
Pilar Zafrilla, PhD principal investigator
Universidad Católica San Antonio de Murcia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORGONO Living Silica Acacia Gum-MMST Powder, ORGONO Living Silica Malto-OSA Powder and ORGONO Living Silica Collagen Booster in people with Aluminium Overload and Biological Availability, run by Fundació Eurecat at 2 sites 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 2 inclusion and 15 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 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Urinary excretion of aluminum (time frame: 7 days). 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 16 Sep 2022.