Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline

Study Overview
=================
Brief Summary
-----------------
By doing this study, researchers hope to learn if older adults with and without cognitive impairment can adhere to a Mediterranean diet.

Detailed Description
-----------------
Participants will be given instruction on following the study designed Mediterranean diet. Participation in the study will last about 9 weeks. Each person will be asked to follow the study diet for 6 weeks. During the study, participants will be asked to track the food they eat and will be monitored by a registered dietitian. Potential participants need to be located within the KC metro area.

Official Title
-----------------
Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline

Conditions
-----------------
Alzheimer's Disease, Cognitive Impairment

Intervention / Treatment
-----------------
* Other: Mediterranean Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cognitively normal older adults over the age of 65 or individuals with a diagnosis of MCI or AD (any age) Have a study partner, if diagnosed with MCI or AD Body mass index (BMI) range between 20 - 35 kg/m2 Speak English as a primary language Exclusion Criteria: Serious medical risk Adherence to specialized diet regimes Already consume a Mediterranean diet pattern

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitively Normal<br>Persons who are considered to have normal cognitive function. A registered dietician will meet with each person to discuss the Mediterranean Diet. | Other: Mediterranean Diet<br>* Diet consisting of fruits, vegetables, grains, dairy, olive oils, seafood, and nuts. It is low in red meat and solid fats.<br>|
| Active Comparator: Mild Cognitive Impairment<br>Persons diagnosed mild cognitive impairment (MCI). A registered dietician will meet with each person to discuss the Mediterranean Diet. | Other: Mediterranean Diet<br>* Diet consisting of fruits, vegetables, grains, dairy, olive oils, seafood, and nuts. It is low in red meat and solid fats.<br>|
| Experimental: Mild to Moderate Alzheimer's Disease<br>Persons diagnosed with mild to moderate Alzheimer's disease (AD). A registered dietician will meet with each person to discuss the Mediterranean Diet. | Other: Mediterranean Diet<br>* Diet consisting of fruits, vegetables, grains, dairy, olive oils, seafood, and nuts. It is low in red meat and solid fats.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants completing the study | Determine feasibility of this patient population's ability to maintain the diet. Outcome will be measured by the number of participants who complete the entire study. | Week 6 |