Absorption; Disorder Clinical Trial
— BIOSILICIOfficial title:
Randomized, Crossover, Double Blinded, Non-inferiority Study of Three Products Rich in Organic Silicon, in Postprandrial Situation
NCT number | NCT03108508 |
Other study ID # | BIOSILICI |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | July 30, 2017 |
Verified date | July 2020 |
Source | Technological Centre of Nutrition and Health, Spain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of the present study is to evaluate the non-inferiority of the absorption parameters of three silicon supplements in human volunteers.
Status | Completed |
Enrollment | 5 |
Est. completion date | July 30, 2017 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Technological Centre of Nutrition and Health (CTNS) | Reus | Tarragona |
Lead Sponsor | Collaborator |
---|---|
Technological Centre of Nutrition and Health, Spain | Hospital Universitari Sant Joan de Reus, SILICIUM ESPAÑA LABORATORIOS SLU, University Rovira i Virgili |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | concentration of sillicium in urine samples | concentration of sillicium in urine samples will be measured by inductively coupled plasma optical emission spectrometry. | 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) | |
Secondary | concentration of sillicium in plasma | concentration of silicon in blood/plasma samples will be measured by inductively coupled plasma optical emission spectrometry. . |
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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