Effects of Dietary Interventions on the Aging Brain

Study Overview
=================
Brief Summary
-----------------
The researchers will investigate whether caloric restriction or dietary supplementation could provide positive effects on general brain functions in healthy elderly people.

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, a healthy diet rich in unsaturated fatty acids and low in calories should improve cognitive functions such as learning and memory. To test this hypothesis, the researchers study general brain functions in healthy elderly subjects (50-80 years old) during a short term diet.

Official Title
-----------------
Phase IV Interventional Study: Effects of Dietary Interventions on Brain Functions in Healthy Elderly People

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Behavioral: Caloric restriction
* Dietary Supplement: Omega-3 (fish oil capsules)
* Dietary Supplement: Placebo
* Dietary Supplement: Resveratrol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects 50-80 years old moderate to heavy weight (BMI 25-30) must be able to change diet/take supplements at home Exclusion Criteria: diabetes younger than 50 years BMI < 25 psychiatric medication severe disease MMSE < 26 eating disorders

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caloric restriction + placebo supplementation<br> | Behavioral: Caloric restriction<br>* 20-30% CR for 6 months<br>Dietary Supplement: Placebo<br>* Daily corn oil capsules for 6 months<br>|
| Experimental: Omega-3 supplementation<br> | Dietary Supplement: Omega-3 (fish oil capsules)<br>* 2g/day DHA/EPA capsules for 6 months<br>|
| Placebo Comparator: Placebo supplementation<br> | Dietary Supplement: Placebo<br>* Daily corn oil capsules for 6 months<br>|
| Experimental: Resveratrol supplementation<br> | Dietary Supplement: Resveratrol<br>* daily resveratrol for 6 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Auditory verbal Learning Task |  | Baseline (timepoint 0), after 6 months (timepoint 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional/Structural brain changes |  | Baseline (timepoint 0), after 6 months (timepoint 6 months) | 
| Plasma biomarkers |  | Baseline (timepoint 0), after 6 months (timepoint 6 months)f intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diet, elderly, cognition, prevention, cognitive decline, Lifestyle