Technological Centre of Nutrition and Health (CTNS)
Reus, Tarragona, 43204, Spain
Completed
NCT Number: NCT03108508
Non-inferiority Bioavailabilty Study of 3 Silicon-rich Supplements
The objective of the present study is to evaluate the non-inferiority of the absorption parameters of three silicon supplements in human volunteers.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Prod1
Dietary Supplement60 mL of product (water, silicic acid, Equisetum Arvense, Rosmarinus officinalis) (Silicic acid) equivalent to 21.6 mg of elemental silicon.
Other names: G5
Prod2
Dietary Supplement1.4 g of product (Orthosalicic acid) equivalent to 21.6 mg of elemental silicon
Other names: Orgono powder
Prod3
Dietary Supplement120 mL of product (Aloe barbadensis Miller, organic silicon, potassium sorbate, cítric acid) (Organic silicon) equivalent to 21.6 mg of elemental silicon
Other names: G7 Aloe
Primary outcomes
-
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 outcomes
-
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.
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Sponsors and collaborators
Lead sponsor
Technological Centre of Nutrition and Health, Spain
Other
Collaborators
- Hospital Universitari Sant Joan de Reus
- SILICIUM ESPAÑA LABORATORIOS SLU
- University Rovira i Virgili
Registry information
Official study title
Randomized, Crossover, Double Blinded, Non-inferiority Study of Three Products Rich in Organic Silicon, in Postprandrial Situation
Acronym: BIOSILICI
Important dates
- Study start
- 2017
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Apr 11, 2017
- Registry last updated
- Jul 20, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.