Effects of Dietary Interventions on the Brain in Mild Cognitive Impairment (MCI)
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
1 other identifier
interventional
330
1 country
1
Brief Summary
The study will investigate whether dietary modification could provide positive effects on brain functions in elderly people with mild cognitive impairment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 12, 2010
CompletedFirst Posted
Study publicly available on registry
October 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 28, 2017
July 1, 2017
5.9 years
October 12, 2010
July 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alzheimer's Disease Assessment Scale - cognitive subscale
Prior to intervention and after 6 months of intervention
Secondary Outcomes (2)
Functional/Structural brain changes
Prior to intervention and after 6 months of intervention
Plasma biomarkers
Prior to intervention and after 6 months of intervention
Study Arms (6)
Caloric restriction
EXPERIMENTALomega-3 supplementation
EXPERIMENTALresveratrol supplementation
EXPERIMENTALplacebo
PLACEBO COMPARATOR2nd step: intervention + physical /cognitive training
EXPERIMENTALmost effective dietary intervention plus physical and cognitive training
2nd step: most effective dietary intervention plus control
PLACEBO COMPARATORmost effective dietary intervention plus control
Interventions
6 months of resveratrol supplementation
most effective dietary intervention plus physical and cognitive training
most effective dietary intervention plus control
Eligibility Criteria
You may qualify if:
- subjects with mild cognitive impairment
- years old
- moderate to heavy weight (BMI 25-35)
You may not qualify if:
- dementia
- diabetes
- severe disease
- younger than 50 years
- BMI \< 25
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Neurology, Charité Universitätsmedizin Berlin
Berlin, Germany
Related Publications (5)
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.
PMID: 26433119RESULTKobe 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.
PMID: 28326010RESULTWitte 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.
PMID: 27511061RESULTWirth 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.
PMID: 27037094RESULTKobe 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.
PMID: 26912492RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Agnes Floeel, Prof.
Charité University Berlin
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med. Agnes Flöel, Neurologie
Study Record Dates
First Submitted
October 12, 2010
First Posted
October 13, 2010
Study Start
August 1, 2010
Primary Completion
July 1, 2016
Study Completion
December 1, 2016
Last Updated
July 28, 2017
Record last verified: 2017-07