NCT02621554

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

November 6, 2015

Last Update Submit

February 6, 2017

Conditions

Healthy

Keywords

MemoryResveratrolelderlycognition

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Verbal Learning Task Scores at 6 months

    Baseline (timepoint 0), after 6 months (timepoint 6 months)

Secondary Outcomes (5)

  • Change from baseline Verbal Learning Task Scores at 12 months

    after 12 months (timepoint 12 months)

  • Mini Mental State Examination

    Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months)

  • Structural changes on the brain MRI images

    Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months)

  • Functional changes on the brain MRI images

    Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months)

  • Plasma biomarkers

    Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months)

Study Arms (2)

resveratrol supplementation

EXPERIMENTAL

Dietary Supplement: Resveratrol

Dietary Supplement: resveratrol supplementation

placebo supplementation

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Dietary Supplement: Placebo

Interventions

resveratrol supplementationDIETARY_SUPPLEMENT

6 months of resveratrol supplementation

resveratrol supplementation
PlaceboDIETARY_SUPPLEMENT

6 months of placebo intake

placebo supplementation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Leipzig, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29548848DERIVED

Study Officials

  • Arno Villringer, Prof.

    Max Planck Institute for Human Cognitive and Brain Sciences

    STUDY CHAIR

  • Arno Villringer

    Max Planck Institute for Human Cognitive and Brain Sciences

    STUDY DIRECTOR

  • Veronica Witte

    Max Planck Institute for Human Cognitive and Brain Sciences

    STUDY DIRECTOR

  • Veronica Witte

    Max Planck Institute for Human Cognitive and Brain Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2015

First Posted

December 3, 2015

Study Start

April 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 8, 2017

Record last verified: 2017-02

Locations

DE(1)