HealthyNCT02621554
Impact of Resveratrol on Brain Function and Structure
A study testing resveratrol supplementation in people with Healthy, run by Max Planck Institute for Human Cognitive and Brain Sciences at 1 site in Germany.
Trial summary
The study will investigate whether resveratrol could provide positive effects on memory and brain structures and functions in healthy elderly participants. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- resveratrol supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Jan 2017
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects who are healthy or with subjective memory complaints
- older than 60 years old
- normal to overweight participants (BMI: 22-40 kg/sqm)
Who cannot join
- dementia
- Psychiatric diseases
- severe untreated internal diseases
- diabetes
- younger than 60 years
- BMI < 22 or >40
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences
Leipzig
About this study
The study will investigate whether resveratrol could provide positive effects on memory and brain structures and functions in healthy elderly participants.
Read the detailed description
Cell and animal studies postulated various beneficial effects of resveratrol, ranging from a reduction of inflammatory processes and the treatment of cancer to the prevention of cardiovascular diseases and stroke. With regard to cognitive decline, rodent models for Alzheimer's disease (AD) showed improved learning and decelerated hippocampal neurodegeneration after intake of resveratrol.
Animal and first human studies provided evidence that resveratrol might serve as an easy, cost-effective option to develop novel prevention and treatment strategies against age-associated cognitive decline. To test this hypothesis, the researchers study general brain structure and function on healthy older individuals (> 60years old).
- Conditions
- Healthy
- Being tested
- resveratrol supplementation, Placebo
- Keywords
- Memory, Resveratrol, elderly, cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resveratrol supplementationDietary supplement
6 months of resveratrol supplementation
PlaceboDietary supplement
6 months of placebo intake
| Study group | Role | What they receive |
|---|---|---|
| resveratrol supplementation | Experimental | Dietary Supplement: Resveratrol Receives: Dietary Supplement: resveratrol supplementation |
| placebo supplementation | Placebo comparator | Dietary Supplement: Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Verbal Learning Task Scores at 6 months
Measured: Baseline (timepoint 0), after 6 months (timepoint 6 months)
Secondary outcomes (5)
Change from baseline Verbal Learning Task Scores at 12 months
Measured: after 12 months (timepoint 12 months)
Mini Mental State Examination
Measured: Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months)
Structural changes on the brain MRI images
Measured: Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months)
Functional changes on the brain MRI images
Measured: Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months)
Plasma biomarkers
Measured: Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startApr 2016
- Primary completionJan 2017
- Study completionJan 2017
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Planck Institute for Human Cognitive and Brain Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leipzig, Evolva SA
- Responsible party
- Sponsor
- Investigators
- Arno Villringer, Prof., Study chair, Max Planck Institute for Human Cognitive and Brain SciencesArno Villringer, Study director, Max Planck Institute for Human Cognitive and Brain SciencesVeronica Witte, Study director, Max Planck Institute for Human Cognitive and Brain SciencesVeronica Witte, Principal investigator, Max Planck Institute for Human Cognitive and Brain Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621554
- Sponsor's protocol ID
- resveratrol_mpi_01
- Status last verified
- Feb 2017
- First submitted
- 6 Nov 2015
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huhn S, Beyer F, Zhang R, Lampe L, Grothe J, Kratzsch J, Willenberg A, Breitfeld J, Kovacs P, Stumvoll M, Trampel R, Bazin PL, Villringer A, Witte AV. Effects of resveratrol on memory performance, hippocampus connectivity and microstructure in older adults - A randomized controlled trial. Neuroimage. 2018 Jul 1;174:177-190. doi: 10.1016/j.neuroimage.2018.03.023. Epub 2018 Mar 13.
PubMed 29548848
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Resveratrol on Brain Function and Structure
- ClinicalTrials.gov ID
- NCT02621554
- Acronym / sponsor ID
- resveratrol_mpi_01
- Conditions
- Healthy
- Keywords
- Memory, Resveratrol, elderly, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Max Planck Institute for Human Cognitive and Brain SciencesUniversity, hospital or other
- Collaborators
- University of Leipzig, Evolva SA
- Study start
- Apr 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 3 Dec 2015 (estimated)
- 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 study will investigate whether resveratrol could provide positive effects on memory and brain structures and functions in healthy elderly participants.
Detailed description
Cell and animal studies postulated various beneficial effects of resveratrol, ranging from a reduction of inflammatory processes and the treatment of cancer to the prevention of cardiovascular diseases and stroke. With regard to cognitive decline, rodent models for Alzheimer's disease (AD) showed improved learning and decelerated hippocampal neurodegeneration after intake of resveratrol.
Animal and first human studies provided evidence that resveratrol might serve as an easy, cost-effective option to develop novel prevention and treatment strategies against age-associated cognitive decline. To test this hypothesis, the researchers study general brain structure and function on healthy older individuals (> 60years old).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resveratrol supplementation | Experimental | Dietary Supplement: resveratrol supplementationDietary Supplement: Resveratrol |
| placebo supplementation | Placebo comparator | Dietary Supplement: PlaceboDietary Supplement: Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects who are healthy or with subjective memory complaints
- older than 60 years old
- normal to overweight participants (BMI: 22-40 kg/sqm)
Key exclusion criteria (6 listed)
- dementia
- Psychiatric diseases
- severe untreated internal diseases
- diabetes
- younger than 60 years
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 |
|---|---|---|
| resveratrol supplementation6 months of resveratrol supplementation | Dietary supplement | resveratrol supplementation |
| Placebo6 months of placebo intake | Dietary supplement | placebo supplementation |
Primary outcome
Change from baseline Verbal Learning Task Scores at 6 months
Time frame: Baseline (timepoint 0), after 6 months (timepoint 6 months)
5 secondary outcomes
Change from baseline Verbal Learning Task Scores at 12 months
Time frame: after 12 months (timepoint 12 months)
Mini Mental State Examination
Time frame: Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months)
Structural changes on the brain MRI images
Time frame: Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months)
Functional changes on the brain MRI images
Time frame: Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months)
Plasma biomarkers
Time frame: Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 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 8 Feb 2017.
- Derived from this study: PubMed 29548848Huhn S, Beyer F, Zhang R, Lampe L, Grothe J, Kratzsch J, Willenberg A, Breitfeld J, Kovacs P, Stumvoll M, Trampel R, Bazin PL, Villringer A, Witte AV. Effects of resveratrol on memory performance, hippocampus connectivity and microstructure in older adults - A randomized controlled trial. Neuroimage. 2018 Jul 1;174:177-190. doi: 10.1016/j.neuroimage.2018.03.023. Epub 2018 Mar 13.
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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.
Arno Villringer, Prof. study chair
Max Planck Institute for Human Cognitive and Brain Sciences
Arno Villringer study director
Max Planck Institute for Human Cognitive and Brain Sciences
Veronica Witte study director
Max Planck Institute for Human Cognitive and Brain Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resveratrol supplementation in people with Healthy, run by Max Planck Institute for Human Cognitive and Brain Sciences at 1 site in Germany.
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 6 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 8 Feb 2017. 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 Germany. 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?
Change from baseline Verbal Learning Task Scores at 6 months (time frame: Baseline (timepoint 0), after 6 months (timepoint 6 months)). 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 NCT02621554, 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 8 Feb 2017.