Effects of Dietary Interventions on the Brain in Mild Cognitive Impairment (MCI)
NCT ID: NCT01219244
Last Updated: 2017-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
330 participants
INTERVENTIONAL
2010-08-31
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Caloric restriction
caloric restriction
6 months of caloric restriction (15 %)
omega-3 supplementation
omega-3 supplementation
6 months of omega-3 supplementation
resveratrol supplementation
resveratrol supplementation
6 months of resveratrol supplementation
placebo
Placebo
6 months of placebo intake
2nd step: intervention + physical /cognitive training
most effective dietary intervention plus physical and cognitive training
2nd step: intervention + physical / cognitive training
most effective dietary intervention plus physical and cognitive training
2nd step: most effective dietary intervention plus control
most effective dietary intervention plus control
2nd step: intervention + control
most effective dietary intervention plus control
Interventions
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caloric restriction
6 months of caloric restriction (15 %)
omega-3 supplementation
6 months of omega-3 supplementation
resveratrol supplementation
6 months of resveratrol supplementation
Placebo
6 months of placebo intake
2nd step: intervention + physical / cognitive training
most effective dietary intervention plus physical and cognitive training
2nd step: intervention + control
most effective dietary intervention plus control
Eligibility Criteria
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Inclusion Criteria
* 50-80 years old
* moderate to heavy weight (BMI 25-35)
Exclusion Criteria
* diabetes
* severe disease
* younger than 50 years
* BMI \< 25
50 Years
80 Years
ALL
No
Sponsors
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German Federal Ministry of Education and Research
OTHER_GOV
Charite University, Berlin, Germany
OTHER
Responsible Party
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Agnes Flöel
Prof. Dr. med. Agnes Flöel, Neurologie
Principal Investigators
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Agnes Floeel, Prof.
Role: STUDY_CHAIR
Charité University Berlin
Locations
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Department of Neurology, Charité Universitätsmedizin Berlin
Berlin, , Germany
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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nutrition_memory_01
Identifier Type: -
Identifier Source: org_study_id
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