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Effects of Dietary Interventions on the Brain in Mild Cognitive Impairment (MCI)

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: NCT01219244
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : July 28, 2017
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE October 12, 2010
First Posted Date  ICMJE October 13, 2010
Last Update Posted Date July 28, 2017
Study Start Date  ICMJE August 2010
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2010)		 Alzheimer's Disease Assessment Scale - cognitive subscale [ Time Frame: Prior to intervention and after 6 months of intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
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 Brain in Mild Cognitive Impairment (MCI)
Official Title  ICMJE Enhancing Memory Functions in Patients With Mild Cognitive Impairment by Dietary Interventions and in Combination With Exercise and Cognitive Training - Proof of Concept and Mechanisms
Brief Summary The study will investigate whether dietary modification could provide positive effects on brain functions in elderly people with mild cognitive impairment.
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, dietary modification (caloric restriction, omega-3 fatty acids and resveratrol) should improve cognitive functions such as learning and memory. To test this hypothesis, the researchers study general brain functions in elderly subjects (50-80 years old) with mild cognitive impairment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Mild Cognitive Impairment
Intervention  ICMJE
  • Behavioral: caloric restriction
    6 months of caloric restriction (15 %)
  • Behavioral: omega-3 supplementation
    6 months of omega-3 supplementation
  • Behavioral: resveratrol supplementation
    6 months of resveratrol supplementation
  • Behavioral: Placebo
    6 months of placebo intake
  • Behavioral: 2nd step: intervention + physical / cognitive training
    most effective dietary intervention plus physical and cognitive training
  • Behavioral: 2nd step: intervention + control
    most effective dietary intervention plus control
Study Arms  ICMJE
  • Experimental: Caloric restriction
    Intervention: Behavioral: caloric restriction
  • Experimental: omega-3 supplementation
    Intervention: Behavioral: omega-3 supplementation
  • Experimental: resveratrol supplementation
    Intervention: Behavioral: resveratrol supplementation
  • Placebo Comparator: placebo
    Intervention: Behavioral: Placebo
  • Experimental: 2nd step: intervention + physical /cognitive training
    most effective dietary intervention plus physical and cognitive training
    Intervention: Behavioral: 2nd step: intervention + physical / cognitive training
  • Placebo Comparator: 2nd step: most effective dietary intervention plus control
    most effective dietary intervention plus control
    Intervention: Behavioral: 2nd step: intervention + control
Publications *

*   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 Completed
Estimated Enrollment  ICMJE
 (submitted: October 12, 2010)		 330
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • subjects with mild cognitive impairment
  • 50-80 years old
  • moderate to heavy weight (BMI 25-35)

Exclusion Criteria:

  • dementia
  • diabetes
  • severe disease
  • younger than 50 years
  • BMI < 25
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT01219244
Other Study ID Numbers  ICMJE nutrition_memory_01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Agnes Flöel, Charite University, Berlin, Germany
Original Responsible Party Prof. Dr. med. Agnes Flöel, Neurologie, Charite Campus Mitte, Chariteplatz 1, 10117 Berlin
Current Study Sponsor  ICMJE Charite University, Berlin, Germany
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE German Federal Ministry of Education and Research
Investigators  ICMJE
Study Chair: Agnes Floeel, Prof. Charité University Berlin
PRS Account Charite University, Berlin, Germany
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP