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

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.

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.

Conditions

• Aluminium Overload
• Biological Availability

Interventions

DIETARY_SUPPLEMENT

ORGONO Living Silica Acacia Gum-MMST Powder

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.

DIETARY_SUPPLEMENT

ORGONO Living Silica Malto-OSA Powder

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.

DIETARY_SUPPLEMENT

ORGONO Living Silica Collagen Booster

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.

DIETARY_SUPPLEMENT

Placebo

Participants will consume one capsule per day and one bottle per day. Capsule composition: Hydroxypropyl methylcellulose 320 mg/capsule. Bottle composition: water 100 ml.

Sponsors & Collaborators

• Silicium Laboratories S.L.

  collaborator UNKNOWN

• San Antonio Technologies S.L.

  collaborator UNKNOWN

• Catholic University of Murcia (UCAM)

  collaborator UNKNOWN

• Zaidin Experimental Station, Spanish Council for Scientific Research (CSIC) Agency

  collaborator UNKNOWN

• Fundació Eurecat

  lead OTHER

Principal Investigators

• Josep M Del Bas, PhD · UTNS (Eurecat-Reus)

• Pilar Zafrilla, PhD · Universidad Católica San Antonio de Murcia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-05-09

Primary Completion

2022-06-12

Completion

2022-06-12

Countries

• Spain

Study Locations