NCT05098093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
26 days until next milestone

Study Start

First participant enrolled

November 23, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2022

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

October 6, 2021

Last Update Submit

April 12, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • (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 Outcomes (6)

  • AUC 0-t for the main metabolites of the products.

    From 0 to 180 min after product ingestion

  • Serum peak concentration (Cmax) of the metabolites of the tested products.

    From 0 to 180 min after product ingestion

  • Time to serum peak concentration (Tmax) of the metabolites of the tested 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.

    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

    185 min after product intake

  • +1 more secondary outcomes

Other Outcomes (4)

  • AUC(0-t) of the main volatile metabolite of the tested products in serum

    From 0 to 180 min after product ingestion

  • Cmax of the main volatile metabolite of the tested products in serum

    From 0 to 180 min after product ingestion

  • Tmax of the main volatile metabolite of the tested products in serum

    From 0 to 180 min after product ingestion

  • +1 more other outcomes

Study Arms (3)

Standardized botanical extract

ACTIVE COMPARATOR
Dietary Supplement: SBE

Dry botanical extract

ACTIVE COMPARATOR
Dietary Supplement: DBE

Botanical powder

ACTIVE COMPARATOR
Dietary Supplement: BP

Interventions

SBEDIETARY_SUPPLEMENT

Hard-shell capsule

Standardized botanical extract
DBEDIETARY_SUPPLEMENT

Hard-shell capsule

Dry botanical extract
BPDIETARY_SUPPLEMENT

Hard-shell capsule

Botanical powder

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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,
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIC Inserm 1405, University Hospital Clermont-Ferrand,

Clermont-Ferrand, 63003, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2021

First Posted

October 28, 2021

Study Start

November 23, 2021

Primary Completion

March 21, 2022

Study Completion

March 21, 2022

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations

FR(1)