BioavailabilityNCT06306911
Bioavailability of Aronia Melanocarpa
A study testing Aronia Melanocarpa extract in people with Bioavailability and Kinetics, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The main objective of this study is to study the bioavailability and kinetics of acute Aronia Melanocarpa supplementation in healthy young (18-35 years) and older adults (55-75 years) adults. During the test day, participants will ingest a drink consisting of Aronia Melanocarpa extract (AME). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability, Kinetics
- What is being tested?
- Aronia Melanocarpa extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Mar 2024to Aug 2024
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 18-35 kg/m2
- Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
- Stable body weight (weight gain or loss < 3 kg in the past three months)
- Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
Who cannot join
- Smoking or smoking cessation < 12 months
- Severe medical conditions, including asthma, kidney failure, auto-inflammatory diseases, rheumatoid arthritis, diabetes mellitus, cardiovascular disease, gastrointestinal disorders such as Crohn's disease, colitis
- Use of dietary supplements or medication affecting the main outcomes of the study (e.g. affecting gut metabolism, blood pressure medication)
- Use of an investigational product within another biomedical intervention trial within the previous month
- Abuse of drugs
- More than 3 alcoholic consumptions per day
Show all 9Show fewer
- Known pregnancy or lactation
- Known allergy to study product
- Difficult venepuncture
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University
Maastricht
Sanne Ahles, Msc, s.ahles@maastrichtuniversity.nl
Jogchum Plat, Prof
About this study
Official title: Evaluating Kinetics and Bioavailability of Aronia Melanocarpa Extract in Healthy Young and Older Adults
The main objective of this study is to study the bioavailability and kinetics of acute Aronia Melanocarpa supplementation in healthy young (18-35 years) and older adults (55-75 years) adults. During the test day, participants will ingest a drink consisting of Aronia Melanocarpa extract (AME). The bioavailability and kinetics of AME will be assessed via frequent blood sampling, urine collection, and faecal sampling, in which AME and metabolite profiles will be quantified.
- Conditions
- Bioavailability, Kinetics
- Being tested
- Aronia Melanocarpa extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aronia Melanocarpa extractDietary supplement
Aronia Melanocarpa extract (AME) consisting of a mixture of anthocyanins and other polyphenols
| Study group | Role | What they receive |
|---|---|---|
| Aronia Melanocarpa extract | Experimental | a drink consisting of AME (Aronia Melanocarpa extract) and water. Receives: Dietary Supplement: Aronia Melanocarpa extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aronia metabolites in blood
Concentrations and quality of Aronia metabolites in blood analysed with LC-MS
Measured: time = 0 hours until t = 48 hours
Aronia metabolites in urine
Concentrations and quality of Aronia metabolites in urine analysed with LC-MS
Measured: time = 0 hours until t = 48 hours
Secondary outcomes (4)
Aronia metabolites in feces
Concentrations and quality of Aronia metabolites in feces analysed with LC-MS
Measured: time = 0 hours
length - baseline characteristics
length
Measured: time = 0 hours
weight - baseline characteristics
weight
Measured: time = 0 hours
blood pressure (systolic and diastolic) - baseline characteristics
blood pressure
Measured: time = 0 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start25 Mar 2024
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- BioActor
- Responsible party
- Sponsor
- Investigators
- Jogchum Plat, Prof, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306911
- Sponsor's protocol ID
- BB-BAM
- Status last verified
- Jun 2024
- First submitted
- 1 Feb 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Kinetics and Bioavailability of Aronia Melanocarpa Extract in Healthy Young and Older Adults
- ClinicalTrials.gov ID
- NCT06306911
- Acronym / sponsor ID
- BB-BAM
- Conditions
- Bioavailability, Kinetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- BioActor
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 12 Mar 2024 (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.
The main objective of this study is to study the bioavailability and kinetics of acute Aronia Melanocarpa supplementation in healthy young (18-35 years) and older adults (55-75 years) adults. During the test day, participants will ingest a drink consisting of Aronia Melanocarpa extract (AME). The bioavailability and kinetics of AME will be assessed via frequent blood sampling, urine collection, and faecal sampling, in which AME and metabolite profiles will be quantified.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aronia Melanocarpa extract | Experimental | Dietary Supplement: Aronia Melanocarpa extracta drink consisting of AME (Aronia Melanocarpa extract) and water. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI between 18-35 kg/m2
- Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
- Stable body weight (weight gain or loss < 3 kg in the past three months)
- Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
Key exclusion criteria (9 listed)
- Smoking or smoking cessation < 12 months
- Severe medical conditions, including asthma, kidney failure, auto-inflammatory diseases, rheumatoid arthritis, diabetes mellitus, cardiovascular disease, gastrointestinal disorders such as Crohn's disease, colitis
- Use of dietary supplements or medication affecting the main outcomes of the study (e.g. affecting gut metabolism, blood pressure medication)
- Use of an investigational product within another biomedical intervention trial within the previous month
- Abuse of drugs
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 |
|---|---|---|
| Aronia Melanocarpa extractAronia Melanocarpa extract (AME) consisting of a mixture of anthocyanins and other polyphenols | Dietary supplement | Aronia Melanocarpa extract |
Primary outcome
Aronia metabolites in blood
Time frame: time = 0 hours until t = 48 hours
Concentrations and quality of Aronia metabolites in blood analysed with LC-MS
Aronia metabolites in urine
Time frame: time = 0 hours until t = 48 hours
Concentrations and quality of Aronia metabolites in urine analysed with LC-MS
4 secondary outcomes
Aronia metabolites in feces
Time frame: time = 0 hours
length - baseline characteristics
Time frame: time = 0 hours
weight - baseline characteristics
Time frame: time = 0 hours
blood pressure (systolic and diastolic) - baseline characteristics
Time frame: time = 0 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Jogchum Plat, Prof principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aronia Melanocarpa extract in people with Bioavailability and Kinetics, run by Maastricht University Medical Center at 1 site in Netherlands.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanne Ahles, Msc (+31437114555, s.ahles@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aronia metabolites in blood (time frame: time = 0 hours until t = 48 hours). The study lists 2 primary outcomes in all. 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 Jun 2024.