HealthyNCT05098093
Bioavailabity of the Major Metabolites of a Botanical Extract, in Healthy Adults
A study testing SBE, DBE and BP in people with Healthy, run by Activ'inside at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SBE, DBE and BP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2021to 21 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
CIC Inserm 1405, University Hospital Clermont-Ferrand,
Clermont-Ferrand, 63003
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- SBE, DBE, BP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBEDietary supplement
Hard-shell capsule
DBEDietary supplement
Hard-shell capsule
BPDietary supplement
Hard-shell capsule
| Study group | Role | What they receive |
|---|---|---|
| Standardized botanical extract | Active comparator | Not described Receives: Dietary Supplement: SBE |
| Dry botanical extract | Active comparator | Not described Receives: Dietary Supplement: DBE |
| Botanical powder | Active comparator | Not described Receives: Dietary Supplement: BP |
What is being measured
The primary outcome is the main question the study is designed to answer.
(AUC 0-t) : Area under the curve of the serum concentration of the main metabolites of the products.
Measured: From 0 to 180 min after product ingestion
Secondary outcomes (6)
AUC 0-t for the main metabolites of the products.
Comparison between tested products
Measured: From 0 to 180 min after product ingestion
Serum peak concentration (Cmax) of the metabolites of the tested products.
Determination and comparison between products
Measured: 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
Measured: 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
Measured: 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
Measured: 185 min after product intake
Systolic and diastolic blood pressure
Comparison between tested products
Measured: 183 min after product ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start23 Nov 2021
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Activ'inside
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CIC Inserm 1405, University Hospital Clermont-Ferrand, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098093
- Sponsor's protocol ID
- BIODAI-2021
- Status last verified
- Apr 2023
- First submitted
- 6 Oct 2021
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailabity of the Major Metabolites of a Botanical Extract, in Healthy Adults : a Randomized, Cross-over, Open-label, Clinical Study
- ClinicalTrials.gov ID
- NCT05098093
- Acronym / sponsor ID
- BIODAI-2021
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Activ'insideIndustry (pharma, biotech, devices)
- Collaborators
- CIC Inserm 1405, University Hospital Clermont-Ferrand, France
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standardized botanical extract | Active comparator | Dietary Supplement: SBE |
| Dry botanical extract | Active comparator | Dietary Supplement: DBE |
| Botanical powder | Active comparator | Dietary Supplement: BP |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (29 listed)
- 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;
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBEHard-shell capsule | Dietary supplement | Standardized botanical extract |
| DBEHard-shell capsule | Dietary supplement | Dry botanical extract |
| BPHard-shell capsule | Dietary supplement | Botanical powder |
Primary outcome
(AUC 0-t) : Area under the curve of the serum concentration of the main metabolites of the products.
Time frame: From 0 to 180 min after product ingestion
6 secondary outcomes
AUC 0-t for the main metabolites of the products.
Time frame: From 0 to 180 min after product ingestion
Serum peak concentration (Cmax) of the metabolites of the tested products.
Time frame: From 0 to 180 min after product ingestion
Time to serum peak concentration (Tmax) of the metabolites of the tested products.
Time frame: 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.
Time frame: 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
Time frame: 185 min after product intake
Systolic and diastolic blood pressure
Time frame: 183 min after product ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBE, DBE and BP in people with Healthy, run by Activ'inside at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(AUC 0-t) : Area under the curve of the serum concentration of the main metabolites of the products. (time frame: From 0 to 180 min after product ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.