Clinical trial NCT02621554: Impact of Resveratrol on Brain Function and Structure
Official title: Impact of Resveratrol on Brain Function and Structure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Memory
Resveratrol
elderly
cognition
Lead sponsor: Max Planck Institute for Human Cognitive and Brain Sciences
Sponsor class: OTHER
Collaborators: name: University of Leipzig
name: Evolva SA
First posted: 2015-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

Eligibility criteria: Inclusion Criteria:

* subjects who are healthy or with subjective memory complaints
* older than 60 years old
* normal to overweight participants (BMI: 22-40 kg/sqm)

Exclusion Criteria:

* dementia
* Psychiatric diseases
* severe untreated internal diseases
* diabetes
* younger than 60 years
* BMI \< 22 or \>40

Primary outcomes:
measure: Change from baseline Verbal Learning Task Scores at 6 months
timeFrame: Baseline (timepoint 0), after 6 months (timepoint 6 months)
Secondary outcomes:
measure: Change from baseline Verbal Learning Task Scores at 12 months
timeFrame: after 12 months (timepoint 12 months)
measure: Mini Mental State Examination
timeFrame: Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months)
measure: Structural changes on the brain MRI images
timeFrame: Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months)
measure: Functional changes on the brain MRI images
timeFrame: Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months)
measure: Plasma biomarkers
timeFrame: Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months)
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences
Study officials:
affiliation: Max Planck Institute for Human Cognitive and Brain Sciences
name: Arno Villringer, Prof.
role: STUDY_CHAIR
affiliation: Max Planck Institute for Human Cognitive and Brain Sciences
name: Arno Villringer
role: STUDY_DIRECTOR
affiliation: Max Planck Institute for Human Cognitive and Brain Sciences
name: Veronica Witte
role: STUDY_DIRECTOR
affiliation: Max Planck Institute for Human Cognitive and Brain Sciences
name: Veronica Witte
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.