NCT03108508

Non-inferiority Bioavailabilty Study of 3 Silicon-rich Supplements

Randomized, Crossover, Double Blinded, Non-inferiority Study of Three Products Rich in Organic Silicon, in Postprandrial Situation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Technological Centre of Nutrition and Health, Spain · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Absorption; Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-05-01
• Primary completion: 2017-06-30
• Completion: 2017-07-30
• First posted: 2017-04-11
• Last updated: 2020-07-20

Locations

1 site across 1 country: Spain