Effect of Three Silicon Based Food Supplements on the Urinary Excretion of Aluminum and Other Metals (SILIAL)
Condition: Aluminium Overload; Biological Availability
Study type: Interventional

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.
    

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.
    

Intervention name(s): ORGONO Living Silica Acacia Gum-MMST Powder; ORGONO Living Silica Malto-OSA Powder; ORGONO Living Silica Collagen Booster; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.; 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.; Participants will consume one capsule per day and one bottle per day. Capsule composition: Hydroxypropyl methylcellulose 320 mg/capsule. Bottle composition: water 100 ml.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Silicon; Aluminum; urinary excretion; Food supplement