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

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219244
• Other study ID #: nutrition_memory_01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 12, 2010
• Last updated: July 26, 2017
• Start date: August 2010
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Germany	Department of Neurology, Charité Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Köbe T, Witte AV, Schnelle A, Grittner U, Tesky VA, Pantel J, Schuchardt JP, Hahn A, Bohlken J, Rujescu D, Flöel A. Vitamin B-12 concentration, memory performance, and hippocampal structure in patients with mild cognitive impairment. Am J Clin Nutr. 2016 — View Citation

Köbe T, Witte AV, Schnelle A, Lesemann A, Fabian S, Tesky VA, Pantel J, Flöel 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 — View Citation

Köbe T, Witte AV, Schnelle A, Tesky VA, Pantel J, Schuchardt JP, Hahn A, Bohlken J, Grittner U, Flöel A. Impact of Resveratrol on Glucose Control, Hippocampal Structure and Connectivity, and Memory Performance in Patients with Mild Cognitive Impairment. F — View Citation

Wirth M, Pichet Binette A, Brunecker P, Köbe T, Witte AV, Flöel 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: 10.1177/0271678X — View Citation

Witte AV, Köbe T, Graunke A, Schuchardt JP, Hahn A, Tesky VA, Pantel J, Flöel 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 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Assessment Scale - cognitive subscale		Prior to intervention and after 6 months of intervention
Secondary	Functional/Structural brain changes		Prior to intervention and after 6 months of intervention
Secondary	Plasma biomarkers		Prior to intervention and after 6 months of intervention