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

NCT ID: NCT05098093

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-23
• Study Completion Date: 2022-03-21

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standardized botanical extract

Group Type: ACTIVE_COMPARATOR

SBE

Intervention Type: DIETARY_SUPPLEMENT

Hard-shell capsule

Dry botanical extract

Group Type: ACTIVE_COMPARATOR

DBE

Intervention Type: DIETARY_SUPPLEMENT

Hard-shell capsule

Botanical powder

Group Type: ACTIVE_COMPARATOR

BP

Intervention Type: DIETARY_SUPPLEMENT

Hard-shell capsule

Interventions

SBE

Hard-shell capsule

Intervention Type: DIETARY_SUPPLEMENT

DBE

Hard-shell capsule

Intervention Type: DIETARY_SUPPLEMENT

BP

Hard-shell capsule

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

CIC Inserm 1405, University Hospital Clermont-Ferrand, France

UNKNOWN

Sponsor Role: collaborator

Activ'inside

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CIC Inserm 1405, University Hospital Clermont-Ferrand,

Clermont-Ferrand, , France

Countries

France

Other Identifiers

BIODAI-2021

Identifier Type: -

Identifier Source: org_study_id