Impact of Resveratrol on Brain Function and Structure

NCT ID: NCT02621554

Last Updated: 2017-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-01-31

Brief Summary

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

Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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resveratrol supplementation

Dietary Supplement: Resveratrol

Group Type EXPERIMENTAL

resveratrol supplementation

Intervention Type DIETARY_SUPPLEMENT

6 months of resveratrol supplementation

placebo supplementation

Dietary Supplement: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

6 months of placebo intake

Interventions

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resveratrol supplementation

6 months of resveratrol supplementation

Intervention Type DIETARY_SUPPLEMENT

Placebo

6 months of placebo intake

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Leipzig

OTHER

Sponsor Role collaborator

Evolva SA

INDUSTRY

Sponsor Role collaborator

Max Planck Institute for Human Cognitive and Brain Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arno Villringer, Prof.

Role: STUDY_CHAIR

Max Planck Institute for Human Cognitive and Brain Sciences

Arno Villringer

Role: STUDY_DIRECTOR

Max Planck Institute for Human Cognitive and Brain Sciences

Veronica Witte

Role: STUDY_DIRECTOR

Max Planck Institute for Human Cognitive and Brain Sciences

Veronica Witte

Role: PRINCIPAL_INVESTIGATOR

Max Planck Institute for Human Cognitive and Brain Sciences

Locations

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

Leipzig, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 29548848 (View on PubMed)

Study Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Statistical Analysis Plan

05.01.2017 updated because of an amendment of ethnic proposal.

View Document

Other Identifiers

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resveratrol_mpi_01

Identifier Type: -

Identifier Source: org_study_id

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