Effects of Dietary Interventions on the Aging Brain

April 18, 2013 updated by: Agnes Floel, University Hospital Muenster

Phase IV Interventional Study: Effects of Dietary Interventions on Brain Functions in Healthy Elderly People

The researchers will investigate whether caloric restriction or dietary supplementation could provide positive effects on general brain functions in healthy elderly people.

Study Overview

Status

Unknown

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, a healthy diet rich in unsaturated fatty acids and low in calories should improve cognitive functions such as learning and memory. To test this hypothesis, the researchers study general brain functions in healthy elderly subjects (50-80 years old) during a short term diet.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • 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

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy subjects
  • 50-80 years old
  • moderate to heavy weight (BMI 25-30)
  • must be able to change diet/take supplements at home

Exclusion Criteria:

  • diabetes
  • younger than 50 years
  • BMI < 25
  • psychiatric medication
  • severe disease
  • MMSE < 26
  • eating disorders

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo supplementation
Dietary supplement: Placebo
Daily corn oil capsules for 6 months
Experimental: Caloric restriction + placebo supplementation
Behavioral: Caloric restriction
20-30% CR for 6 months
Dietary supplement: Placebo
Daily corn oil capsules for 6 months
Experimental: Omega-3 supplementation
Dietary supplement: Omega-3 (fish oil capsules)
2g/day DHA/EPA capsules for 6 months
Experimental: Resveratrol supplementation
Dietary supplement: Resveratrol
daily resveratrol for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Auditory verbal Learning Task
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
Functional/Structural brain changes
Time Frame: Baseline (timepoint 0), after 6 months (timepoint 6 months)
Baseline (timepoint 0), after 6 months (timepoint 6 months)
Plasma biomarkers
Time Frame: Baseline (timepoint 0), after 6 months (timepoint 6 months)f intervention
Baseline (timepoint 0), after 6 months (timepoint 6 months)f intervention

Collaborators and Investigators

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

Sponsor

University Hospital Muenster

Collaborators

Charite University, Berlin, Germany

Investigators

  • Study Chair: Agnes Flöel, Professor, Charite University, Berlin, Germany
  • Principal Investigator: Veronica Witte, Dr, Charite University, Berlin, Germany

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

November 1, 2009

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

October 14, 2009

First Submitted That Met QC Criteria

October 15, 2009

First Posted (Estimate)

October 16, 2009

Study Record Updates

Last Update Posted (Estimate)

April 19, 2013

Last Update Submitted That Met QC Criteria

April 18, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ernaehrung-Neuromod 02

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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