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| Name | Class |
|---|---|
| CIC Inserm 1405, University Hospital Clermont-Ferrand, France | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized botanical extract | Active Comparator |
| |
| Dry botanical extract | Active Comparator |
| |
| Botanical powder | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBE | Dietary Supplement | Hard-shell capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| (AUC 0-t) : Area under the curve of the serum concentration of the main metabolites of the products. | From 0 to 180 min after product ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0-t for the main metabolites of the products. | Comparison between tested products | From 0 to 180 min after product ingestion |
| Serum peak concentration (Cmax) of the metabolites of the tested products. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-t) of the main volatile metabolite of the tested products in serum | Determination and comparison between SBE and DBE | From 0 to 180 min after product ingestion |
| Cmax of the main volatile metabolite of the tested products in serum |
Inclusion Criteria:
Non-inclusion Criteria:
Subjects complying with at least one of the following criteria will not be eligible:
Known metabolic abnormality or clinically significant medical condition, such as:
Hypertension (SBP≥160 mm Hg or DBP ≥100 mm Hg).
Use of any type of medication or narcotic drug (detected either by the self-declaration of the participant and/ or by the urine TetraHydroCannabinol (THC) test) currently or within the past 2 months before entry into the study;
Self-reported alcohol intake of >10 units/ week
Weight changes above 10% body weight within the past 6 months before entering the study;
Currently under prescribed diet regimen, whatever the reason;
Consumption of food supplement(s) currently or within the past 4 weeks before entry into the study, such as but not limited to: botanicals, vitamins, minerals, amino acids; anti-oxydant;
Any intolerance or allergy documented or suspected to one of the components of the study products;
Subject presenting a psychological or linguistic inability to sign the informed consent;
Subject under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
Subject participating in another biomedical study or participation in another study where a product (ie: dietary supplement) were consumed within the 3 months before entry into this study;
Any regulatory reason according to national applicable regulation;
Subject having received indemnities for clinical trial reaching at least 4500 Euros considering the last 12 months.
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIC Inserm 1405, University Hospital Clermont-Ferrand, | Clermont-Ferrand | 63003 | France |
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| DBE |
| Dietary Supplement |
Hard-shell capsule |
|
| BP | Dietary Supplement | Hard-shell capsule |
|
Determination and comparison between products
| From 0 to 180 min after product ingestion |
| Time to serum peak concentration (Tmax) of the metabolites of the tested products. | Determination and comparison between products | From 0 to 180 min after product ingestion |
| Elimination half-life (T1/2) of serum metabolites of the tested products defined by the time required for the concentration of product metabolites to decrease to half of Cmax. | Determination and comparison between products | From 0 to 180 min after product ingestion |
| Concentration of urinary crocetin (ng/mg of creatinine) of the tested products at the end of the visit | Determination and comparison between products | 185 min after product intake |
| Systolic and diastolic blood pressure | Comparison between tested products | 183 min after product ingestion |
Determination and comparison between SBE and DBE
| From 0 to 180 min after product ingestion |
| Tmax of the main volatile metabolite of the tested products in serum | Determination and comparison between SBE and DBE | From 0 to 180 min after product ingestion |
| T1/2 of the main volatile metabolite of the tested products in serum | Determination and comparison between SBE and DBE | From 0 to 180 min after product ingestion |