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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01219244
First received: October 12, 2010
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention 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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale - cognitive subscale [ Time Frame: Prior to intervention and after 6 months of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional/Structural brain changes [ Time Frame: Prior to intervention and after 6 months of intervention ] [ Designated as safety issue: No ]
  • Plasma biomarkers [ Time Frame: Prior to intervention and after 6 months of intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: August 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219244

Contacts
Contact: Theresa Köbe, Graduate theresa.koebe@charite.de
Contact: Veronica Witte, PhD veronica.witte@charite.de

Locations
Germany
Department of Neurology, Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany
Contact: Theresa Koebe, graduate       theresa.koebe@charite.de   
Contact: Veronica Witte, PhD       veronica.witte@charite.de   
Principal Investigator: Agnes Floeel, Prof.         
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Investigators
Study Chair: Agnes Floeel, Prof. Charité University Berlin
  More Information

No publications provided

Responsible Party: Agnes Flöel, Prof. Dr. med. Agnes Flöel, Neurologie, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01219244     History of Changes
Other Study ID Numbers: nutrition_memory_01
Study First Received: October 12, 2010
Last Updated: June 2, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
memory
diet
elderly
cognition
prevention
lifestyle

Additional relevant MeSH terms:
Mild Cognitive Impairment
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 01, 2014