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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
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Agnes Floel, University Hospital Muenster

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

Condition or disease Intervention/treatment Phase
Healthy Behavioral: Caloric restriction Dietary Supplement: Omega-3 (fish oil capsules) Dietary Supplement: Placebo Dietary Supplement: Resveratrol Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Phase IV Interventional Study: Effects of Dietary Interventions on Brain Functions in Healthy Elderly People
Study Start Date : November 2009
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arms and Interventions
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Arm Intervention/treatment
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
Placebo Comparator: Placebo supplementation Dietary Supplement: Placebo
Daily corn oil capsules for 6 months
Experimental: Resveratrol supplementation Dietary Supplement: Resveratrol
daily resveratrol for 6 months


Outcome Measures
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Primary Outcome Measures :
  1. Auditory verbal Learning Task [ Time Frame: Baseline (timepoint 0), after 6 months (timepoint 6 months) ]

Secondary Outcome Measures :
  1. Functional/Structural brain changes [ Time Frame: Baseline (timepoint 0), after 6 months (timepoint 6 months) ]
  2. Plasma biomarkers [ Time Frame: Baseline (timepoint 0), after 6 months (timepoint 6 months)f intervention ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996229


Contacts
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Contact: Veronica Witte, Dr veronica.witte@charite.de
Contact: Agnes Flöel, Professor agnes.floeel@charite.de

Locations
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Germany
Department of Neurology, Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Veronica Witte, Dr       veronica.witte@charite.de   
Contact: Agnes Flöel, Professor       agnes.floeel@charite.de   
Sponsors and Collaborators
University Hospital Muenster
Charite University, Berlin, Germany
Investigators
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Study Chair: Agnes Flöel, Professor Charite University, Berlin, Germany
Principal Investigator: Veronica Witte, Dr Charite University, Berlin, Germany
More Information
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Responsible Party: Agnes Floel, Prof. Dr. med. Agnes Flöel, University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00996229    
Other Study ID Numbers: Ernaehrung-Neuromod 02
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013
Keywords provided by Agnes Floel, University Hospital Muenster:
Diet
elderly
cognition
 prevention
cognitive decline
Lifestyle
Additional relevant MeSH terms:
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Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents