Non-inferiority Bioavailabilty Study of 3 Silicon-rich Supplements

Overview

The objective of the present study is to evaluate the non-inferiority of the absorption parameters of three silicon supplements in human volunteers.

Full Title of Study: “Randomized, Crossover, Double Blinded, Non-inferiority Study of Three Products Rich in Organic Silicon, in Postprandrial Situation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2017

Detailed Description

The objective of the present study is to evaluate the non-inferiority of the absorption parameters of three silicon supplements in human volunteers. Participants: 5 healthy men over 18 years old, with normal serum creatinine levels. Treatment consists of one product consumption every week, and measuring postprandrial response at 0, 30, 60, 90, 120, 180, 240 and 360 min, in blood, and urine in two periods of three hours each. The statistical analysis will follow the principles specified in the guidelines of the ICHE and CPMP/EWP/908/99 ICHE Points to Consider on Multiplicity Issues in Clinical Trials.

Interventions

  • Dietary Supplement: Prod1
    • 60 mL of product (water, silicic acid, Equisetum Arvense, Rosmarinus officinalis) (Silicic acid) equivalent to 21.6 mg of elemental silicon.
  • Dietary Supplement: Prod2
    • 1.4 g of product (Orthosalicic acid) equivalent to 21.6 mg of elemental silicon
  • Dietary Supplement: Prod3
    • 120 mL of product (Aloe barbadensis Miller, organic silicon, potassium sorbate, cítric acid) (Organic silicon) equivalent to 21.6 mg of elemental silicon

Arms, Groups and Cohorts

  • Experimental: Prod1
    • G5 Siliplant
  • Experimental: Prod2
    • Orgono Powder®
  • Experimental: Prod3
    • G7 ALOE

Clinical Trial Outcome Measures

Primary Measures

  • concentration of sillicium in urine samples
    • Time Frame: Urine will be collected in two 3-h collections (0-180min and 181-360 min) in two separate containers at Visit 1, Visit 2 and Visit 3 (1 week between visits)
    • concentration of sillicium in urine samples will be measured by inductively coupled plasma optical emission spectrometry.

Secondary Measures

  • concentration of sillicium in plasma
    • Time Frame: Blood samples will be collected to determine baseline plasma silicon value (time 0 min = T0). After ingestion of one of the study products, additional blood samples will be collected at 30, 60, 90 and 120 min at Visit 1, Visit 2 and Visit 3
    • concentration of silicon in blood/plasma samples will be measured by inductively coupled plasma optical emission spectrometry. .

Participating in This Clinical Trial

Inclusion Criteria

  • Adults men or women (>18 years old) – With normal serum creatinine levels. – Written informed consent provided before the initial screening visit. Exclusion Criteria:

  • Suffering from chronic diseases – Suffering from intestinal disorders – Consuming silicon supplements in the 7 days prior to inclusion in the study. – Consuming medicines containing silicon in the 7 days prior to inclusion in the study. – Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study. – Failing to follow study guidelines.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Technological Centre of Nutrition and Health, Spain
  • Collaborator
    • SILICIUM ESPAÑA LABORATORIOS SLU
  • Provider of Information About this Clinical Study
    • Sponsor

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