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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: caloric restriction
* Behavioral: omega-3 supplementation
* Behavioral: resveratrol supplementation
* Behavioral: Placebo
* Behavioral: 2nd step: intervention + physical / cognitive training
* Behavioral: 2nd step: intervention + control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caloric restriction<br> | Behavioral: caloric restriction<br>* 6 months of caloric restriction (15 %)<br>|
| Experimental: omega-3 supplementation<br> | Behavioral: omega-3 supplementation<br>* 6 months of omega-3 supplementation<br>|
| Experimental: resveratrol supplementation<br> | Behavioral: resveratrol supplementation<br>* 6 months of resveratrol supplementation<br>|
| Placebo Comparator: placebo<br> | Behavioral: Placebo<br>* 6 months of placebo intake<br>|
| Experimental: 2nd step: intervention + physical /cognitive training<br>most effective dietary intervention plus physical and cognitive training | Behavioral: 2nd step: intervention + physical / cognitive training<br>* most effective dietary intervention plus physical and cognitive training<br>|
| Placebo Comparator: 2nd step: most effective dietary intervention plus control<br>most effective dietary intervention plus control | Behavioral: 2nd step: intervention + control<br>* most effective dietary intervention plus control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Assessment Scale - cognitive subscale |  | Prior to intervention and after 6 months of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional/Structural brain changes |  | Prior to intervention and after 6 months of intervention | 
| Plasma biomarkers |  | Prior to intervention and after 6 months of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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memory, diet, elderly, cognition, prevention, lifestyle