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Effects of Dietary Interventions on the Aging Brain

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Agnes Floel, University Hospital Muenster.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00996229
First Posted: October 16, 2009
Last Update Posted: April 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Agnes Floel, University Hospital Muenster
  Purpose
The researchers will investigate whether caloric restriction or dietary supplementation could provide positive effects on general brain functions in healthy elderly people.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Agnes Floel, University Hospital Muenster:

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

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

Estimated Enrollment: 300
Study Start Date: November 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
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
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
Contact: Veronica Witte, Dr veronica.witte@charite.de
Contact: Agnes Flöel, Professor agnes.floeel@charite.de

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

Responsible Party: Agnes Floel, Prof. Dr. med. Agnes Flöel, University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00996229     History of Changes
Other Study ID Numbers: Ernaehrung-Neuromod 02
First Submitted: October 14, 2009
First Posted: October 16, 2009
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:
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