Non-inferiority Bioavailabilty Study of 3 Silicon-rich Supplements (BIOSILICI)

Technological Centre of Nutrition and Health, Spain

Status: Completed

Conditions: Absorption; Disorder

Treatments: Dietary Supplement: Prod2; Dietary Supplement: Prod1; Dietary Supplement: Prod3

Study type: Interventional

Funder types: Other

Identifiers

NCT03108508

BIOSILICI

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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5 participants in 3 patient groups

Prod1

Experimental group

Description:

G5 Siliplant

Treatment:

Dietary Supplement: Prod1

Prod2

Experimental group

Description:

Orgono Powder®

Treatment:

Dietary Supplement: Prod2

Prod3

Experimental group

Description:

G7 ALOE

Treatment:

Dietary Supplement: Prod3