Bioavailabity of the Major Metabolites of a Botanical Extract, in Healthy Adults

Healthy Clinical Trial

Official title:

Bioavailabity of the Major Metabolites of a Botanical Extract, in Healthy Adults : a Randomized, Cross-over, Open-label, Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05098093
• Other study ID #: BIODAI-2021
• Status: Completed
• Phase: N/A
• Start date: November 23, 2021
• Est. completion date: March 21, 2022

Study information

• Verified date: April 2023
• Source: Activ'inside
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 21, 2022
• Est. primary completion date: March 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Male adults

• Age between 18 and 35 years (limits included);

• Non-smoking individuals (nor tobacco, nor electronic cigarette nor cannabis, former smokers can be included if they stopped smoking at least 2 years ago);

• Body Mass Index = 19 and < 30 kg/m2.

• Considered healthy based on their medical history, clinical examination and biological examination;

• Subjects capable of and willing to comply with the protocol and to give their written informed consent.

• Subjects affiliated with a social security scheme.

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:

• Cardiovascular disease (other than hypertension),

• Neurological disease,

• Psychatric disease,

• Immunological disease,

• Endocrine disease (including diabetes or thyroid diseases),

• Chronic kidney disease,

• Heamatological abnormalities

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• SBE
Hard-shell capsule
• DBE
Hard-shell capsule
• BP
Hard-shell capsule

Locations

Country	Name	City	State
France	CIC Inserm 1405, University Hospital Clermont-Ferrand,	Clermont-Ferrand cedex 1

Sponsors (2)

Lead Sponsor	Collaborator
Activ'inside	CIC Inserm 1405, University Hospital Clermont-Ferrand, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Cmax 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
Other	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
Other	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
Primary	(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
Secondary	AUC 0-t for the main metabolites of the products.	Comparison between tested products	From 0 to 180 min after product ingestion
Secondary	Serum peak concentration (Cmax) of the metabolites of the tested products.	Determination and comparison between products	From 0 to 180 min after product ingestion
Secondary	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
Secondary	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
Secondary	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
Secondary	Systolic and diastolic blood pressure	Comparison between tested products	183 min after product ingestion