Brain Vascular FunctionNCT05268133
Aronia and Cognitive Fitness
A study testing Aronia in people with Brain Vascular Function and Cognition, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Previously, beneficial effects of Aronia Melanocarpa extract (AME) supplementation on cognitive performance has been observed in healthy middle-aged adults. However, underlying mechanisms have not yet been addressed. In addition, effects of AME are unknown in subjects at increased risk of cognitive impairment. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Vascular Function, Cognition
- What is being tested?
- Aronia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Jun 2022to 25 Aug 2023
- 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women, aged between 55-75 years
- BMI between 25-35 kg/m2
- Fasting plasma glucose < 7.0 mmol/L
- Fasting serum total cholesterol < 8.0 mmol/L
- Fasting serum triacylglycerol < 4.5 mmol/L
- Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
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- 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
- No difficult venipuncture as evidenced during the screening visit
Who cannot join
- Smoking or smoking cessation < 12 months
- Presence of diabetes mellitus
- Active cardiovascular disease like congestive heart failure or cardiovascular event
- Severe medical conditions, including asthma, chronic obstructive pulmonary disease (COPD), kidney failure, auto-inflammatory diseases or rheumatoid arthritis
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Use of dietary supplements or medication affecting the main outcomes of the study
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- Use of an investigational product within another biomedical intervention trial within the previous month
- Contra-indications for MRI imaging (e.g., pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)
- Left-handedness
- Familial hypercholesterolemia
- Abuse of drugs
- More than 3 alcoholic consumptions per day
- Use medication to treat blood pressure, lipid or glucose metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aronia and Cognitive Fitness: Focus on Brain Insulin-Sensitivity and Vascular Function
Previously, beneficial effects of Aronia Melanocarpa extract (AME) supplementation on cognitive performance has been observed in healthy middle-aged adults. However, underlying mechanisms have not yet been addressed. In addition, effects of AME are unknown in subjects at increased risk of cognitive impairment. It is hypothesized that supplementation with AME enhances (regional) brain vascular function and brain insulin-sensitivity, thereby improving cognitive function of subjects at increased risk of cognitive impairment.
The primary objectives are to investigate effects of AME intake on brain vascular function and insulin-sensitivity in cognitive-control brain areas, while we will also evaluate changes in cognitive function (secondary objective).
The present study is a randomized, double-blind, placebo-controlled, cross-over trial consisting of two study groups and a pre- and post-test day in both study arms.
- Conditions
- Brain Vascular Function, Cognition
- Being tested
- Aronia, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AroniaDietary supplement
As described in experimental arm
ControlDietary supplement
As described in placebo comparator arm
| Study group | Role | What they receive |
|---|---|---|
| Aronia | Experimental | An aronia melanocarpa extract. Study volunteers will receive a daily oral dose of 160 mg AME for 6 weeks. Receives: Dietary Supplement: Aronia |
| Control | Placebo comparator | Cellulose. Study volunteers will receive a daily oral dose of 160 mg cellulose for 6 weeks. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Vascular function
cerebral blood flow as quantified non-invasively by the MRI perfusion method arterial spin labeling (ASL MRI). Higher cerebral blood flow indicates improved brain vascular function.
Measured: Change after 6 weeks of intervention
Brain insulin sensitivity
cerebral blood flow as quantified non-invasively by the MRI perfusion method arterial spin labeling (ASL MRI) before and after application of intranasal insulin (160 IU).
Higher cerebral blood flow after intranasal insulin application indicates improved brain insulin sensitivity
Measured: Change after 6 weeks of intervention
Secondary outcomes (1)
Cognitive performance
Quantified through the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Measured: Change after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start8 Jun 2022
- Primary completion25 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Vascular FunctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter J Joris, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268133
- Sponsor's protocol ID
- METC 21-084
- Status last verified
- Oct 2024
- First submitted
- 24 Feb 2022
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahles S, Plat J, Nijssen KM, Joris PJ. Aronia melanocarpa extract supplementation affects brain vascular function and cognitive performance: A randomized, double-blind, placebo-controlled, cross-over study in older adults with overweight or obesity. Clin Nutr. 2026 Feb;57:106561. doi: 10.1016/j.clnu.2025.106561. Epub 2025 Dec 29.
PubMed 41499921
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aronia and Cognitive Fitness: Focus on Brain Insulin-Sensitivity and Vascular Function
- ClinicalTrials.gov ID
- NCT05268133
- Acronym / sponsor ID
- METC 21-084
- Conditions
- Brain Vascular Function, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 7 Mar 2022 (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.
Previously, beneficial effects of Aronia Melanocarpa extract (AME) supplementation on cognitive performance has been observed in healthy middle-aged adults. However, underlying mechanisms have not yet been addressed. In addition, effects of AME are unknown in subjects at increased risk of cognitive impairment. It is hypothesized that supplementation with AME enhances (regional) brain vascular function and brain insulin-sensitivity, thereby improving cognitive function of subjects at increased risk of cognitive impairment.
The primary objectives are to investigate effects of AME intake on brain vascular function and insulin-sensitivity in cognitive-control brain areas, while we will also evaluate changes in cognitive function (secondary objective).
The present study is a randomized, double-blind, placebo-controlled, cross-over trial consisting of two study groups and a pre- and post-test day in both study arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aronia | Experimental | Dietary Supplement: AroniaAn aronia melanocarpa extract. Study volunteers will receive a daily oral dose of 160 mg AME for 6 weeks. |
| Control | Placebo comparator | Dietary Supplement: ControlCellulose. Study volunteers will receive a daily oral dose of 160 mg cellulose for 6 weeks. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women, aged between 55-75 years
- BMI between 25-35 kg/m2
- Fasting plasma glucose < 7.0 mmol/L
- Fasting serum total cholesterol < 8.0 mmol/L
- Fasting serum triacylglycerol < 4.5 mmol/L
Key exclusion criteria (13 listed)
- Smoking or smoking cessation < 12 months
- Presence of diabetes mellitus
- Active cardiovascular disease like congestive heart failure or cardiovascular event
- Severe medical conditions, including asthma, chronic obstructive pulmonary disease (COPD), kidney failure, auto-inflammatory diseases or rheumatoid arthritis
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
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 |
|---|---|---|
| AroniaAs described in experimental arm | Dietary supplement | Aronia |
| ControlAs described in placebo comparator arm | Dietary supplement | Control |
Primary outcome
Brain Vascular function
Time frame: Change after 6 weeks of intervention
cerebral blood flow as quantified non-invasively by the MRI perfusion method arterial spin labeling (ASL MRI). Higher cerebral blood flow indicates improved brain vascular function.
Brain insulin sensitivity
Time frame: Change after 6 weeks of intervention
cerebral blood flow as quantified non-invasively by the MRI perfusion method arterial spin labeling (ASL MRI) before and after application of intranasal insulin (160 IU). Higher cerebral blood flow after intranasal insulin application indicates improved brain insulin sensitivity
1 secondary outcome
Cognitive performance
Time frame: Change after 6 weeks of intervention
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 24 Sep 2025.
- Derived from this study: PubMed 41499921Ahles S, Plat J, Nijssen KM, Joris PJ. Aronia melanocarpa extract supplementation affects brain vascular function and cognitive performance: A randomized, double-blind, placebo-controlled, cross-over study in older adults with overweight or obesity. Clin Nutr. 2026 Feb;57:106561. doi: 10.1016/j.clnu.2025.106561. Epub 2025 Dec 29.
- 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.
Peter J Joris, PhD 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 in people with Brain Vascular Function and Cognition, 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 9 inclusion and 13 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 24 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
Brain Vascular function (time frame: Change after 6 weeks of intervention). 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?
On the ClinicalTrials.gov record for NCT05268133, which also lists 1 linked publication.
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 24 Sep 2025.