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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: SBE; Dietary supplement: DBE; Dietary supplement: BP

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rémy Evrard; Phone Number: +330473178406; Email: revrard@chu-clermontferrand.fr
• Study Contact Backup: Name: Nicolas Macian; Email: nmacian@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand cedex 1, France, 63003
    • CIC Inserm 1405, University Hospital Clermont-Ferrand,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standardized botanical extract	Dietary supplement: SBE; Hard-shell capsule
Active Comparator: Dry botanical extract	Dietary supplement: DBE; Hard-shell capsule
Active Comparator: Botanical powder	Dietary supplement: BP; Hard-shell capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Activ'inside
• Collaborators: CIC Inserm 1405, University Hospital Clermont-Ferrand, France

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Actual): March 21, 2022
• Study Completion (Actual): March 21, 2022

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BIODAI-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No