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

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
caloric restriction
omega-3 supplementation
resveratrol supplementation
Placebo
2nd step: intervention + physical / cognitive training
2nd step: intervention + control
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring memory, diet, elderly, cognition, prevention, lifestyle

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurology, Charité Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Caloric restriction

omega-3 supplementation

resveratrol supplementation

placebo

2nd step: intervention + physical /cognitive training

2nd step: most effective dietary intervention plus control

Arm Description

most effective dietary intervention plus physical and cognitive training

most effective dietary intervention plus control

Outcomes

Primary Outcome Measures

Alzheimer's Disease Assessment Scale - cognitive subscale

Secondary Outcome Measures

Functional/Structural brain changes
Plasma biomarkers

Full Information

First Posted
October 12, 2010
Last Updated
July 26, 2017
Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01219244
Brief Title
Effects of Dietary Interventions on the Brain in Mild Cognitive Impairment (MCI)
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 Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
memory, diet, elderly, cognition, prevention, lifestyle

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Caloric restriction
Arm Type
Experimental
Arm Title
omega-3 supplementation
Arm Type
Experimental
Arm Title
resveratrol supplementation
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
2nd step: intervention + physical /cognitive training
Arm Type
Experimental
Arm Description
most effective dietary intervention plus physical and cognitive training
Arm Title
2nd step: most effective dietary intervention plus control
Arm Type
Placebo Comparator
Arm Description
most effective dietary intervention plus control
Intervention Type
Behavioral
Intervention Name(s)
caloric restriction
Intervention Description
6 months of caloric restriction (15 %)
Intervention Type
Behavioral
Intervention Name(s)
omega-3 supplementation
Intervention Description
6 months of omega-3 supplementation
Intervention Type
Behavioral
Intervention Name(s)
resveratrol supplementation
Intervention Description
6 months of resveratrol supplementation
Intervention Type
Behavioral
Intervention Name(s)
Placebo
Intervention Description
6 months of placebo intake
Intervention Type
Behavioral
Intervention Name(s)
2nd step: intervention + physical / cognitive training
Intervention Description
most effective dietary intervention plus physical and cognitive training
Intervention Type
Behavioral
Intervention Name(s)
2nd step: intervention + control
Intervention Description
most effective dietary intervention plus control
Primary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale - cognitive subscale
Time Frame
Prior to intervention and after 6 months of intervention
Secondary Outcome Measure Information:
Title
Functional/Structural brain changes
Time Frame
Prior to intervention and after 6 months of intervention
Title
Plasma biomarkers
Time Frame
Prior to intervention and after 6 months of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Floeel, Prof.
Organizational Affiliation
Charité University Berlin
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Neurology, Charité Universitätsmedizin Berlin
City
Berlin
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26433119
Citation
Kobe T, Witte AV, Schnelle A, Lesemann A, Fabian S, Tesky VA, Pantel J, Floel A. Combined omega-3 fatty acids, aerobic exercise and cognitive stimulation prevents decline in gray matter volume of the frontal, parietal and cingulate cortex in patients with mild cognitive impairment. Neuroimage. 2016 May 1;131:226-38. doi: 10.1016/j.neuroimage.2015.09.050. Epub 2015 Oct 1.
Results Reference
result
PubMed Identifier
28326010
Citation
Kobe T, Witte AV, Schnelle A, Tesky VA, Pantel J, Schuchardt JP, Hahn A, Bohlken J, Grittner U, Floel A. Impact of Resveratrol on Glucose Control, Hippocampal Structure and Connectivity, and Memory Performance in Patients with Mild Cognitive Impairment. Front Neurosci. 2017 Mar 7;11:105. doi: 10.3389/fnins.2017.00105. eCollection 2017.
Results Reference
result
PubMed Identifier
27511061
Citation
Witte AV, Kobe T, Graunke A, Schuchardt JP, Hahn A, Tesky VA, Pantel J, Floel A. Impact of leptin on memory function and hippocampal structure in mild cognitive impairment. Hum Brain Mapp. 2016 Dec;37(12):4539-4549. doi: 10.1002/hbm.23327. Epub 2016 Aug 11.
Results Reference
result
PubMed Identifier
27037094
Citation
Wirth M, Pichet Binette A, Brunecker P, Kobe T, Witte AV, Floel A. Divergent regional patterns of cerebral hypoperfusion and gray matter atrophy in mild cognitive impairment patients. J Cereb Blood Flow Metab. 2017 Mar;37(3):814-824. doi: 10.1177/0271678X16641128. Epub 2016 Jul 20.
Results Reference
result
PubMed Identifier
26912492
Citation
Kobe T, Witte AV, Schnelle A, Grittner U, Tesky VA, Pantel J, Schuchardt JP, Hahn A, Bohlken J, Rujescu D, Floel A. Vitamin B-12 concentration, memory performance, and hippocampal structure in patients with mild cognitive impairment. Am J Clin Nutr. 2016 Apr;103(4):1045-54. doi: 10.3945/ajcn.115.116970. Epub 2016 Feb 24.
Results Reference
result

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

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