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

NCT05116982 | Completed

• 1 other identifier: SAT-EURECAT-01-20
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Silicon; Aluminum; urinary excretion; Food supplement

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Secondary Outcomes (10)

• Bioavailability of silicon

  24 hours

• Urinary excretion of mercury

  7 days

• Urinary excretion of nickel

  7 days

• Urinary excretion of arsenic

  7 days

• Urinary excretion of cadmium

  7 days

Study Arms (4)

ORGONO Living Silica Acacia Gum-MMST Powder

EXPERIMENTAL

ORGONO Living Silica Acacia gum-MMST Power. In capsules. One capsule a day for 7 days.

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.

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.

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.

Dietary Supplement: Placebo

Interventions

ORGONO Living Silica Acacia Gum-MMST Powder DIETARY_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 Acacia Gum-MMST Powder

ORGONO Living Silica Malto-OSA Powder DIETARY_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 Malto-OSA Powder

ORGONO Living Silica Collagen Booster DIETARY_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.

ORGONO Living Silica Collagen Booster

Placebo DIETARY_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.

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).
• 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.

Sponsors & Collaborators

• Fundació Eurecat: lead
• Silicium Laboratories S.L.: collaborator
• San Antonio Technologies S.L.: collaborator
• Catholic University of Murcia (UCAM): collaborator
• Zaidin Experimental Station, Spanish Council for Scientific Research (CSIC) Agency: collaborator

Study Sites (2)

Grupo de investigación de nutrición, estrés oxidativo y biodisponibilidad. Universidad Católica de Murcia (UCAM)

Guadalupe, Murcia, 30107, Spain

Location

Eurecat

Reus, 43204, Spain

Location

Related Links

• Technological Centre of Nutrition and Health. Eurecat-Reus.

Study Officials

• Josep M Del Bas, PhD

  UTNS (Eurecat-Reus)

  STUDY DIRECTOR

• Pilar Zafrilla, PhD

  Universidad Católica San Antonio de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 11, 2021
• Study Start: May 9, 2022
• Primary Completion: June 12, 2022
• Study Completion: June 12, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)