Cognitive FunctionNCT03793777
The Effect of Aronia Melanocarpa Extract on Cognitive Function
A study testing Aronia in people with Cognitive Function, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
There is a great interest in improving cognitive performance, including memory and attention. Improved attention is desirable for a large group of people because it is linked to improved performance . Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- Aronia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Oct 2020to 29 Apr 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young adults: ages between 18 and 35
- BM between 18.5-30 kg/m2
Who cannot join
- Current use of (antioxidant) dietary supplements and not willing to quit for the duration of the study duration
- Pre-existing or history of neurological illness
- High blood pressure (>140 systolic and/or >90 diastolic mmHg)
- Use of medication that might have influence on endpoints (e.g. antidepressant)
- Known pregnancy or lactation
- Food allergy to the study product
Show all 9Show fewer
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study, to be decided by the principle investigator, in the 180 days prior to the study
- Abuse of products (> 20 alcoholic consumptions per week and drug usage)
- Participation in a scientific intervention study which may interfere with this study in the 180 days prior to this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Short-term Aronia Melanocarpa Extract Supplementation on Cognitive Function in Healthy Young Adults
There is a great interest in improving cognitive performance, including memory and attention. Improved attention is desirable for a large group of people because it is linked to improved performance . Students and professionals can benefit from improved attention and thus performance in academic and other work environments. In addition, cognitive functioning also plays an important role in sports. Various cognitive skills, including attention, reaction time and motor function, have shown that they can influence sport performance. A completely natural supplement with aronia melanocarpa extract could be a promising way to naturally improve cognitive performance.
Read the detailed description
There is a great interest in improving cognitive performance, including memory and attention. Improved attention is desirable for a large group of people because it is linked to improved performance. Students and professionals can benefit from improved attention and thus performance in academic and other work environments. In addition, cognitive functioning also plays an important role in sports. Various cognitive skills, including attention, reaction time and motor function, have shown that they can influence sport performance. A completely natural supplement with aronia melanocarpa extract could be a promising way to naturally improve cognitive performance. The product in this study is aronia melanocarpa which contains polyphenols. A limited number of clinical studies have already been carried out to see the effect of similar products on cognitive functioning. However, these studies have often been done in older study populations or over a longer period of time. In this study, in healthy adolescents (ages between the 18-35 and with a BMI between 18.5 and 30), the investigators want to test the short term (7 days) effect of aronia melanocarpa extract on cognitive functioning. The investigators will also test the effect of supplementation on the particpant's mood, vascular function, blood biomarkers, retinal vasculature, and subjective cognition.
- Conditions
- Cognitive Function
- Being tested
- Aronia, Placebo
- Keywords
- supplementation, cognition, cognitive function, vascular function, microvasculature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AroniaDietary supplement
daily supplementation
PlaceboDietary supplement
daily supplementation
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | microcrystalline cellulose supplementation Receives: Dietary Supplement: Placebo |
| Aronia | Experimental | aronia melanocarpa supplementation Receives: Dietary Supplement: Aronia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
CANTAB
Measured: After 7 days of supplementation
Secondary outcomes (5)
Mood
VAMS
Measured: After 7 days of supplementation
Biomarkers in blood and saliva
BDNF \& cortisol
Measured: After 7 days of supplementation
Vascular function
SBP \& DBP, PWA \& PWV
Measured: After 7 days of supplementation
Microvasculature
Fundus photography
Measured: After 7 days of supplementation
Subjective cognition
Cognitive Failures Questionnaire
Measured: After 7 days of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start9 Oct 2020
- Primary completion29 Apr 2021
- Study completion29 Apr 2021
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 Cognitive FunctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross-over study with 2 intervention conditions
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- BioActor B.V.
- Responsible party
- Sponsor
- Investigators
- Jogchum Plat, Prof, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793777
- Sponsor's protocol ID
- Brainport_002
- Status last verified
- Sep 2020
- First submitted
- 19 Dec 2018
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahles S, Joris PJ, Plat J. Short-term Aronia melanocarpa extract supplementation improves cognitive performance: a randomized, double-blind, placebo-controlled cross-over study in healthy young adults. Eur J Nutr. 2024 Aug;63(5):1545-1553. doi: 10.1007/s00394-024-03381-3. Epub 2024 Apr 24.
PubMed 38656355
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Short-term Aronia Melanocarpa Extract Supplementation on Cognitive Function in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT03793777
- Acronym / sponsor ID
- Brainport_002
- Conditions
- Cognitive Function
- Keywords
- supplementation, cognition, cognitive function, vascular function, microvasculature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- BioActor B.V.
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 4 Jan 2019 (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.
There is a great interest in improving cognitive performance, including memory and attention. Improved attention is desirable for a large group of people because it is linked to improved performance . Students and professionals can benefit from improved attention and thus performance in academic and other work environments. In addition, cognitive functioning also plays an important role in sports. Various cognitive skills, including attention, reaction time and motor function, have shown that they can influence sport performance. A completely natural supplement with aronia melanocarpa extract could be a promising way to naturally improve cognitive performance.
Detailed description
There is a great interest in improving cognitive performance, including memory and attention. Improved attention is desirable for a large group of people because it is linked to improved performance. Students and professionals can benefit from improved attention and thus performance in academic and other work environments. In addition, cognitive functioning also plays an important role in sports. Various cognitive skills, including attention, reaction time and motor function, have shown that they can influence sport performance. A completely natural supplement with aronia melanocarpa extract could be a promising way to naturally improve cognitive performance. The product in this study is aronia melanocarpa which contains polyphenols. A limited number of clinical studies have already been carried out to see the effect of similar products on cognitive functioning. However, these studies have often been done in older study populations or over a longer period of time. In this study, in healthy adolescents (ages between the 18-35 and with a BMI between 18.5 and 30), the investigators want to test the short term (7 days) effect of aronia melanocarpa extract on cognitive functioning. The investigators will also test the effect of supplementation on the particpant's mood, vascular function, blood biomarkers, retinal vasculature, and subjective cognition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cross-over study with 2 intervention conditions
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: Placebomicrocrystalline cellulose supplementation |
| Aronia | Experimental | Dietary Supplement: Aroniaaronia melanocarpa supplementation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy young adults: ages between 18 and 35
- BM between 18.5-30 kg/m2
Key exclusion criteria (9 listed)
- Current use of (antioxidant) dietary supplements and not willing to quit for the duration of the study duration
- Pre-existing or history of neurological illness
- High blood pressure (>140 systolic and/or >90 diastolic mmHg)
- Use of medication that might have influence on endpoints (e.g. antidepressant)
- Known pregnancy or lactation
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 |
|---|---|---|
| Aroniadaily supplementation | Dietary supplement | Aronia |
| Placebodaily supplementation | Dietary supplement | placebo |
Primary outcome
Cognitive function
Time frame: After 7 days of supplementation
CANTAB
5 secondary outcomes
Mood
Time frame: After 7 days of supplementation
Biomarkers in blood and saliva
Time frame: After 7 days of supplementation
Vascular function
Time frame: After 7 days of supplementation
Microvasculature
Time frame: After 7 days of supplementation
Subjective cognition
Time frame: After 7 days of supplementation
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 5 Sep 2021.
- Derived from this study: PubMed 38656355Ahles S, Joris PJ, Plat J. Short-term Aronia melanocarpa extract supplementation improves cognitive performance: a randomized, double-blind, placebo-controlled cross-over study in healthy young adults. Eur J Nutr. 2024 Aug;63(5):1545-1553. doi: 10.1007/s00394-024-03381-3. Epub 2024 Apr 24.
- 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 in people with Cognitive Function, 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 2 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: finished, as of the sponsor's last update on 5 Sep 2021. 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?
Cognitive function (time frame: After 7 days of supplementation). 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 NCT03793777, 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 5 Sep 2021; AzTrials last refreshed its copy on 31 Oct 2026.