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Effects of Dietary Interventions on the Aging Brain

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.
 
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

Tracking Information
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
 (submitted: November 7, 2011)
Auditory verbal Learning Task [ Time Frame: Baseline (timepoint 0), after 6 months (timepoint 6 months) ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2009)
Auditory verbal Learning Task [ Time Frame: Prior to intervention and after 6 months of intervention ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2009)
  • Functional/Structural brain changes [ Time Frame: Prior to intervention and after 6 months of intervention ]
  • Plasma biomarkers [ Time Frame: Prior to intervention and after 6 months of intervention ]
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Behavioral: Caloric restriction
    20-30% CR for 6 months
  • Dietary Supplement: Omega-3 (fish oil capsules)
    2g/day DHA/EPA capsules for 6 months
  • Dietary Supplement: Placebo
    Daily corn oil capsules for 6 months
  • Dietary Supplement: Resveratrol
    daily resveratrol for 6 months
Study Arms  ICMJE
  • Experimental: Caloric restriction + placebo supplementation
    Interventions:
    • Behavioral: Caloric restriction
    • Dietary Supplement: Placebo
  • Experimental: Omega-3 supplementation
    Intervention: Dietary Supplement: Omega-3 (fish oil capsules)
  • Placebo Comparator: Placebo supplementation
    Intervention: Dietary Supplement: Placebo
  • Experimental: Resveratrol supplementation
    Intervention: Dietary Supplement: Resveratrol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 15, 2009)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Chair: Agnes Flöel, Professor Charite University, Berlin, Germany
Principal Investigator: Veronica Witte, Dr Charite University, Berlin, Germany
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