NCT05116982: SILIAL

Effect of Three Silicon Based Food Supplements on the Urinary Excretion of Aluminum and Other Metals (SILIAL)

Completed NA Last updated 16 September 2022

What this trial tests

NA trial testing ORGONO Living Silica Acacia Gum-MMST Powder in Aluminium Overload in 47 participants. Completed in 12 June 2022.

Timeline

9 May 2022

Primary endpoint
12 June 2022

12 June 2022

Quick facts

Lead sponsor	Fundació Eurecat
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	47
Start date	9 May 2022
Primary completion	12 June 2022
Estimated completion	12 June 2022
Sites	2 locations across Spain

Drugs / interventions tested

• ORGONO Living Silica Acacia Gum-MMST Powder
• ORGONO Living Silica Malto-OSA Powder
• ORGONO Living Silica Collagen Booster
• Placebo

Conditions studied

• Aluminium Overload — all drugs for Aluminium Overload →
• Biological Availability — all drugs for Biological Availability →

Sponsor

Fundació Eurecat

Who can join

Adults 40 to 65, any sex, with Aluminium Overload or Biological Availability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.