Clinical trial NCT01219244: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Mild Cognitive Impairment
Keywords: memory
diet
elderly
cognition
prevention
lifestyle
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2010-10-13
Enrollment: 330
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale - cognitive subscale
timeFrame: Prior to intervention and after 6 months of intervention
Secondary outcomes:
measure: Functional/Structural brain changes
timeFrame: Prior to intervention and after 6 months of intervention
measure: Plasma biomarkers
timeFrame: Prior to intervention and after 6 months of intervention
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Neurology, Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charité University Berlin
name: Agnes Floeel, Prof.
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.