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

NCT05098093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-04-13

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

SBE

Hard-shell capsule

DIETARY_SUPPLEMENT

DBE

Hard-shell capsule

DIETARY_SUPPLEMENT

BP

Hard-shell capsule

Sponsors & Collaborators

  • CIC Inserm 1405, University Hospital Clermont-Ferrand, France

    collaborator UNKNOWN
  • Activ'inside

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2022-03-21
Completion
2022-03-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05098093 on ClinicalTrials.gov