- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00463255
Diet and the Aging Brain
Phase IV Interventional Study: Effect of Diet on Brain Function in Elderly Healthy People
Study Overview
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 potentially devastating effects.
Refering to animal data and empirical studies, 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, we study general brain functions in healthy elderly subjects (50-80 years old) during a short term diet.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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NRW
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Muenster, NRW, Germany, 48149
- University Hospital Muenster, Department of Neurology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy subjects
- 50-80 years old
- moderate to heavy weight
- must be able to change diet at home
Exclusion Criteria:
- diabetes
- younger than 50 years
- BMI < 23
- already participating in other studys
- MMSE > 26
- eating disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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implicit visual-motor learning of a finger sequence of the hand.
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Secondary Outcome Measures
Outcome Measure |
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implicit learning of an artificial language
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several plasma levels related to cognitive functions
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Stefan Knecht, MD, Prof., University Hospital Muenster
- Study Chair: Bernd E Ringelstein, MD, Prof, University Hopsital Muenster
- Principal Investigator: Agnes Floeel, MD, University Hospital Muenster
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Ernaehrung-Neuromod 01
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