Overview

This trial is active, not recruiting.

Condition healthy
Treatments resveratrol supplementation, placebo
Phase phase 2/phase 3
Sponsor Max Planck Institute for Human Cognitive and Brain Sciences
Collaborator University of Leipzig
Start date April 2016
End date February 2017
Trial size 60 participants
Trial identifier NCT02621554, resveratrol_mpi_01

Summary

The study will investigate whether resveratrol could provide positive effects on memory and brain structures and functions in healthy elderly participants.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Dietary Supplement: Resveratrol
resveratrol supplementation
6 months of resveratrol supplementation
(Placebo Comparator)
Dietary Supplement: Placebo
placebo
6 months of placebo intake

Primary Outcomes

Measure
Change from baseline Verbal Learning Task Scores at 6 months
time frame: Baseline (timepoint 0), after 6 months (timepoint 6 months)

Secondary Outcomes

Measure
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)

Eligibility Criteria

Male or female participants at least 60 years old.

Inclusion Criteria: - subjects who are healthy or with subjective memory complaints - older than 60 years old - normal to overweight participants (BMI: 22-34 kg/sqm) Exclusion Criteria: - dementia - Psychiatric diseases - severe untreated internal diseases - diabetes - younger than 60 years - BMI < 22 or >34

Additional Information

Official title Impact of Resveratrol on Brain Function and Structure
Principal investigator Veronica Witte
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).
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Max Planck Institute for Human Cognitive and Brain Sciences.