Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline

Not Applicable

Completed

• Conditions: Alzheimer's Disease; Cognitive Impairment
• Interventions: Other: Mediterranean Diet

• Registration Number: NCT02921672
• Lead Sponsor: University of Kansas Medical Center

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-10-03
• Primary Completion: 2018-06-22
• Study Completion: 2018-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-05
• Last Update Posted: 2019-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild Cognitive Impairment	Mediterranean Diet	Persons diagnosed mild cognitive impairment (MCI). A registered dietician will meet with each person to discuss the Mediterranean Diet.
Cognitively Normal	Mediterranean Diet	Persons who are considered to have normal cognitive function. A registered dietician will meet with each person to discuss the Mediterranean Diet.
Mild to Moderate Alzheimer's Disease	Mediterranean Diet	Persons diagnosed with mild to moderate Alzheimer's disease (AD). A registered dietician will meet with each person to discuss the Mediterranean Diet.

Primary Outcome Measures

Name	Time	Method
Number of participants completing the study	Week 6	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.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States