Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline

University of Kansas

Status: Completed

Conditions: Alzheimer's Disease; Cognitive Impairment

Treatments: Other: Mediterranean Diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02921672

STUDY00003894

P30AG035982 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

By doing this study, researchers hope to learn if older adults with and without cognitive impairment can adhere to a Mediterranean diet.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Cognitively Normal

Active Comparator group

Description:

Persons who are considered to have normal cognitive function. A registered dietician will meet with each person to discuss the Mediterranean Diet.

Treatment:

Other: Mediterranean Diet

Mild Cognitive Impairment

Active Comparator group

Description:

Persons diagnosed mild cognitive impairment (MCI). A registered dietician will meet with each person to discuss the Mediterranean Diet.

Treatment:

Other: Mediterranean Diet

Mild to Moderate Alzheimer's Disease

Experimental group

Description:

Persons diagnosed with mild to moderate Alzheimer's disease (AD). A registered dietician will meet with each person to discuss the Mediterranean Diet.

Treatment:

Other: Mediterranean Diet