A Phase 2/3 interventional study of caloric restriction and omega-3 supplementation in Mild Cognitive Impairment, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-28.
Sponsored by Charite University, Berlin, Germany · Phase 2/3, Interventional, and Prevention
The study will investigate whether dietary modification could provide positive effects on brain functions in elderly people with mild cognitive impairment.
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.
3,842 studies on the registry are indexed under Cognitive Dysfunction; 1,099 are open to participants now.
This study's planned enrollment of 330 is above the median of 65 across 2,807 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: caloric restriction
Behavioral: omega-3 supplementation
Behavioral: resveratrol supplementation
Behavioral: Placebo
most effective dietary intervention plus physical and cognitive training
Behavioral: 2nd step: intervention + physical / cognitive training
most effective dietary intervention plus control
Behavioral: 2nd step: intervention + control
6 months of caloric restriction (15 %)
6 months of omega-3 supplementation
6 months of resveratrol supplementation
6 months of placebo intake
most effective dietary intervention plus physical and cognitive training
most effective dietary intervention plus control
Alzheimer's Disease Assessment Scale - cognitive subscale
Time frame: Prior to intervention and after 6 months of intervention
Functional/Structural brain changes
Time frame: Prior to intervention and after 6 months of intervention
Plasma biomarkers
Time frame: Prior to intervention and after 6 months of intervention
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany