Cognitive ImpairmentNCT03236259
The Effect of Berry Extract Administration on Cognitive Health
A study testing Brainport high dose and Brainport low dose in people with Cognitive Impairment and Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate the effects of daily supplementation of Brainport for a period of 6 months on cognitive health. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Overweight and Obesity
- What is being tested?
- Brainport high dose and Brainport low dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Feb 2017to 21 Aug 2018
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy individuals
- Age between 40 and 60 years
- BMI 25 - 35 kg/m2
Who cannot join
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat). Dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and /or laboratory assessments that might limit participation in or completion of the study protocol.
- Diabetes
- Use of medication that might have influence on endpoints (hypertension medication)
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study in the 180 days prior to the study
- Use of antibiotics in the 30 days prior to the start of the study
- Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
Show all 12Show fewer
- Pregnancy, lactation
- Abuse of products (> 20 alcoholic consumptions per week and drugs)
- Smoking
- Weight gain or loss (> 3 kg in previous 3 months)
- High physical activity (>4.5 hours of running/week)
- History of any side effects towards intake of berries
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effects of daily supplementation of Brainport for a period of 6 months on cognitive health.
- Conditions
- Cognitive Impairment, Overweight and Obesity
- Being tested
- Brainport high dose, Brainport low dose, Placebo
- Medical subject headings
- Cognitive Dysfunction, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brainport high doseDietary supplement
berry extract, high dose. Daily ingestion of capsule
Brainport low doseDietary supplement
Berry extract, low dose. Daily ingestion of capsule
PlaceboDietary supplement
Maltodextrin. Daily ingestion of capsule
| Study group | Role | What they receive |
|---|---|---|
| Brainport high dose | Active comparator | Not described Receives: Dietary Supplement: Brainport high dose |
| Brainport low dose | Active comparator | Not described Receives: Dietary Supplement: Brainport low dose |
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition
test attention with STROOP
Measured: 6 months
Cognition
Test concentration with 'cijferdoorstreep test'
Measured: 6 months
Cognition
Test psychomotor speed with grooved pegboard
Measured: 6 months
Secondary outcomes (5)
vascular structure
measure vascular structure with ultrasound.
Measured: 6 months
Mood
Test mood with visual analogue mood scale. 8 emotions are scored on a 1-10 scale.
Measured: 6 months
Blood pressure
Measured: 6 months
Liver function
analysis of alkaline phosphatase, alanine aminotransferase, aspartaat aminotransferase, bilirubine, gamma-glutamyltransferase to determine liver function.
Measured: 6 months
flavo-enzyme
monoamine oxidase B analysis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start21 Feb 2017
- Primary completion21 Aug 2018
- Study completion21 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- BioActor B.V.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236259
- Sponsor's protocol ID
- Brainport-001
- Status last verified
- Sep 2018
- First submitted
- 20 Jul 2017
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Berry Extract Administration on Cognitive Health
- ClinicalTrials.gov ID
- NCT03236259
- Acronym / sponsor ID
- Brainport-001
- Conditions
- Cognitive Impairment, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- BioActor B.V.
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 1 Aug 2017 (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 purpose of this study is to investigate the effects of daily supplementation of Brainport for a period of 6 months on cognitive health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brainport high dose | Active comparator | Dietary Supplement: Brainport high dose |
| Brainport low dose | Active comparator | Dietary Supplement: Brainport low dose |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy individuals
- Age between 40 and 60 years
- BMI 25 - 35 kg/m2
Key exclusion criteria (12 listed)
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat). Dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and /or laboratory assessments that might limit participation in or completion of the study protocol.
- Diabetes
- Use of medication that might have influence on endpoints (hypertension medication)
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study in the 180 days prior to the study
- Use of antibiotics in the 30 days prior to the start of 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 |
|---|---|---|
| Brainport high doseberry extract, high dose. Daily ingestion of capsule | Dietary supplement | Brainport high dose |
| Brainport low doseBerry extract, low dose. Daily ingestion of capsule | Dietary supplement | Brainport low dose |
| PlaceboMaltodextrin. Daily ingestion of capsule | Dietary supplement | Placebo |
Primary outcome
Cognition
Time frame: 6 months
test attention with STROOP
Cognition
Time frame: 6 months
Test concentration with 'cijferdoorstreep test'
Cognition
Time frame: 6 months
Test psychomotor speed with grooved pegboard
5 secondary outcomes
vascular structure
Time frame: 6 months
Mood
Time frame: 6 months
Blood pressure
Time frame: 6 months
Liver function
Time frame: 6 months
flavo-enzyme
Time frame: 6 months
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 25 Feb 2021.
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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 Brainport high dose and Brainport low dose in people with Cognitive Impairment and Overweight and Obesity, 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 3 inclusion and 12 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 25 Feb 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?
Cognition (time frame: 6 months). The study lists 3 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 25 Feb 2021.