Impact of Resveratrol on Brain Function and Structure

February 6, 2017 updated by: Max Planck Institute for Human Cognitive and Brain Sciences
The study will investigate whether resveratrol could provide positive effects on memory and brain structures and functions in healthy elderly participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany
        • Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: resveratrol supplementation
Dietary Supplement: Resveratrol
Dietary supplement: resveratrol supplementation
6 months of resveratrol supplementation
Placebo Comparator: placebo supplementation
Dietary Supplement: Placebo
Dietary supplement: Placebo
6 months of placebo intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline Verbal Learning Task Scores at 6 months
Time Frame: Baseline (timepoint 0), after 6 months (timepoint 6 months)
Baseline (timepoint 0), after 6 months (timepoint 6 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline Verbal Learning Task Scores at 12 months
Time Frame: after 12 months (timepoint 12 months)
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)
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)
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)
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)
Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Max Planck Institute for Human Cognitive and Brain Sciences

Collaborators

University of Leipzig
Evolva SA

Investigators

  • Study Chair: Arno Villringer, Prof., Max Planck Institute for Human Cognitive and Brain Sciences
  • Study Director: Arno Villringer, Max Planck Institute for Human Cognitive and Brain Sciences
  • Study Director: Veronica Witte, Max Planck Institute for Human Cognitive and Brain Sciences
  • Principal Investigator: Veronica Witte, Max Planck Institute for Human Cognitive and Brain Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

November 6, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • resveratrol_mpi_01

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Statistical Analysis Plan
  2. Statistical Analysis Plan
    Information comments: 05.01.2017 updated because of an amendment of ethnic proposal.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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