- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00996229
Effects of Dietary Interventions on the Aging Brain
Phase IV Interventional Study: Effects of Dietary Interventions on Brain Functions in Healthy Elderly People
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 10117
- Recruiting
- Department of Neurology, Charité Universitätsmedizin Berlin
-
Contact:
- Veronica Witte, Dr
- Email: veronica.witte@charite.de
-
Contact:
- Agnes Flöel, Professor
- Email: agnes.floeel@charite.de
-
-
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 (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
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
|
Daily corn oil capsules for 6 months
|
Experimental: Caloric restriction + placebo supplementation
|
20-30% CR for 6 months
Daily corn oil capsules for 6 months
|
Experimental: Omega-3 supplementation
|
2g/day DHA/EPA capsules for 6 months
|
Experimental: Resveratrol supplementation
|
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
Sponsor
Collaborators
Investigators
- Study Chair: Agnes Flöel, Professor, Charite University, Berlin, Germany
- Principal Investigator: Veronica Witte, Dr, Charite University, Berlin, Germany
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
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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