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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

Study Description
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Brief Summary:
The study will investigate whether dietary modification could provide positive effects on brain functions in elderly people with mild cognitive impairment.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: caloric restriction Behavioral: omega-3 supplementation Behavioral: resveratrol supplementation Behavioral: Placebo Behavioral: 2nd step: intervention + physical / cognitive training Behavioral: 2nd step: intervention + control Phase 2 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, 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : August 2010
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Caloric restriction Behavioral: caloric restriction
6 months of caloric restriction (15 %)
Experimental: omega-3 supplementation Behavioral: omega-3 supplementation
6 months of omega-3 supplementation
Experimental: resveratrol supplementation Behavioral: resveratrol supplementation
6 months of resveratrol supplementation
Placebo Comparator: placebo Behavioral: Placebo
6 months of placebo intake
Experimental: 2nd step: intervention + physical /cognitive training
most effective dietary intervention plus physical and cognitive training
 Behavioral: 2nd step: intervention + physical / cognitive training
most effective dietary intervention plus physical and cognitive training
Placebo Comparator: 2nd step: most effective dietary intervention plus control
most effective dietary intervention plus control
 Behavioral: 2nd step: intervention + control
most effective dietary intervention plus control


Outcome Measures
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Primary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale - cognitive subscale [ Time Frame: Prior to intervention and after 6 months of intervention ]

Secondary Outcome Measures :
  1. Functional/Structural brain changes [ Time Frame: Prior to intervention and after 6 months of intervention ]
  2. Plasma biomarkers [ Time Frame: Prior to intervention and after 6 months of 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:   No
Criteria

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
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): NCT01219244


Locations
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Germany
Department of Neurology, Charité Universitätsmedizin Berlin
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Investigators
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Study Chair: Agnes Floeel, Prof. Charité University Berlin
More Information
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Publications of Results:

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Responsible Party: Agnes Flöel, Prof. Dr. med. Agnes Flöel, Neurologie, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01219244    
Other Study ID Numbers: nutrition_memory_01
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Keywords provided by Agnes Flöel, Charite University, Berlin, Germany:
memory
diet
elderly
 cognition
prevention
lifestyle
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Resveratrol
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Platelet Aggregation Inhibitors