Effects of Dietary Interventions on the Brain in Mild Cognitive Impairment (MCI)

July 26, 2017 updated by: Agnes Flöel, Charite University, Berlin, Germany

Enhancing Memory Functions in Patients With Mild Cognitive Impairment by Dietary Interventions and in Combination With Exercise and Cognitive Training - Proof of Concept and Mechanisms

The study will investigate whether dietary modification could provide positive effects on brain functions in elderly people with mild cognitive impairment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The age-related degradation of cognitive functions even to the point of neurodegenerative disorders such as Alzheimer's disease are a growing public-health concern with devastating effects.

Referring to animal data, empirical studies, and pilot human trials, dietary modification (caloric restriction, omega-3 fatty acids and resveratrol) should improve cognitive functions such as learning and memory. To test this hypothesis, the researchers study general brain functions in elderly subjects (50-80 years old) with mild cognitive impairment.

Study Type

Interventional

Enrollment (Anticipated)

330

Phase

  • Phase 2
  • Phase 3

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
      • Berlin, Germany
        • Department of Neurology, Charité Universitätsmedizin Berlin

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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subjects with mild cognitive impairment
  • 50-80 years old
  • moderate to heavy weight (BMI 25-35)

Exclusion Criteria:

  • dementia
  • diabetes
  • severe disease
  • younger than 50 years
  • BMI < 25

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Behavioral: Placebo
6 months of placebo intake
Experimental: Caloric restriction
Behavioral: caloric restriction
6 months of caloric restriction (15 %)
Experimental: omega-3 supplementation
Behavioral: omega-3 supplementation
6 months of omega-3 supplementation
Experimental: resveratrol supplementation
Behavioral: resveratrol supplementation
6 months of resveratrol supplementation
Experimental: 2nd step: intervention + physical /cognitive training
most effective dietary intervention plus physical and cognitive training
Behavioral: 2nd step: intervention + physical / cognitive training
most effective dietary intervention plus physical and cognitive training
Placebo Comparator: 2nd step: most effective dietary intervention plus control
most effective dietary intervention plus control
Behavioral: 2nd step: intervention + control
most effective dietary intervention plus control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Alzheimer's Disease Assessment Scale - cognitive subscale
Time Frame: Prior to intervention and after 6 months of intervention
Prior to intervention and after 6 months of intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional/Structural brain changes
Time Frame: Prior to intervention and after 6 months of intervention
Prior to intervention and after 6 months of intervention
Plasma biomarkers
Time Frame: Prior to intervention and after 6 months of intervention
Prior to intervention and after 6 months of intervention

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Study Chair: Agnes Floeel, Prof., Charite University Berlin

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

August 1, 2010

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 12, 2010

First Submitted That Met QC Criteria

October 12, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Actual)

July 28, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nutrition_memory_01

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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