Effects of Dietary Interventions on the Aging Brain
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ClinicalTrials.gov Identifier: NCT00996229 |
Recruitment Status : Unknown
Verified April 2013 by Agnes Floel, University Hospital Muenster.
Recruitment status was: Recruiting
First Posted : October 16, 2009
Last Update Posted : April 19, 2013
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Sponsor:
University Hospital Muenster
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Agnes Floel, University Hospital Muenster
Tracking Information | |||||||
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First Submitted Date ICMJE | October 14, 2009 | ||||||
First Posted Date ICMJE | October 16, 2009 | ||||||
Last Update Posted Date | April 19, 2013 | ||||||
Study Start Date ICMJE | November 2009 | ||||||
Estimated Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Auditory verbal Learning Task [ Time Frame: Baseline (timepoint 0), after 6 months (timepoint 6 months) ] | ||||||
Original Primary Outcome Measures ICMJE |
Auditory verbal Learning Task [ Time Frame: Prior to intervention and after 6 months of intervention ] | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Effects of Dietary Interventions on the Aging Brain | ||||||
Official Title ICMJE | Phase IV Interventional Study: Effects of Dietary Interventions on Brain Functions in Healthy Elderly People | ||||||
Brief Summary | The researchers will investigate whether caloric restriction or dietary supplementation could provide positive effects on general brain functions in healthy elderly people. | ||||||
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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Healthy | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Unknown status | ||||||
Estimated Enrollment ICMJE |
300 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | February 2014 | ||||||
Estimated Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years to 80 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Germany | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00996229 | ||||||
Other Study ID Numbers ICMJE | Ernaehrung-Neuromod 02 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Agnes Floel, University Hospital Muenster | ||||||
Study Sponsor ICMJE | University Hospital Muenster | ||||||
Collaborators ICMJE | Charite University, Berlin, Germany | ||||||
Investigators ICMJE |
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PRS Account | University Hospital Muenster | ||||||
Verification Date | April 2013 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |