CIC Inserm 1405, University Hospital Clermont-Ferrand,
Clermont-Ferrand, 63003, France
NCT Number: NCT05098093
Scientific research on the beneficial effects of botanical extracts has led to a better understanding of the role of its bioactive compounds, but the bioavailability in human remains largely unknown. Indeed, the most of publications investigated the bioavailability of metabolites of spices in in vitro cells model or animal experiments but few clinical studies have been conducted.
Therefore, the aim of this study is to characterize and quantify in blood, the main metabolite compounds of a botanical extract, following its administration by different routes (oral or sublingual) and with different preparations (extract or powder), in quantity equivalent to those having demonstrated biological properties.
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Notify Me18 year–35 year
Male
Interventional
Not applicable
Clermont-Ferrand, 63003, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-inclusion Criteria:
Subjects complying with at least one of the following criteria will not be eligible:
Exclusion criteria
During the study, in case of emergence of a new health condition or treatment considered as non-inclusion criteria or likely to affect the study parameters according to Investigator's judgment, the participants will be excluded from the study
Hard-shell capsule
Hard-shell capsule
Hard-shell capsule
Time frame: From 0 to 180 min after product ingestion
Time frame: From 0 to 180 min after product ingestion
Comparison between tested products
Time frame: From 0 to 180 min after product ingestion
Determination and comparison between products
Time frame: From 0 to 180 min after product ingestion
Determination and comparison between products
Time frame: From 0 to 180 min after product ingestion
Determination and comparison between products
Time frame: 185 min after product intake
Determination and comparison between products
Time frame: 183 min after product ingestion
Comparison between tested products
Time frame: From 0 to 180 min after product ingestion
Determination and comparison between SBE and DBE
Time frame: From 0 to 180 min after product ingestion
Determination and comparison between SBE and DBE
Time frame: From 0 to 180 min after product ingestion
Determination and comparison between SBE and DBE
Time frame: From 0 to 180 min after product ingestion
Determination and comparison between SBE and DBE
Activ'inside
Industry
Bioavailabity of the Major Metabolites of a Botanical Extract, in Healthy Adults : a Randomized, Cross-over, Open-label, Clinical Study
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.
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