Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline

February 5, 2019 updated by: University of Kansas Medical Center
By doing this study, researchers hope to learn if older adults with and without cognitive impairment can adhere to a Mediterranean diet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants completing the study
Time Frame: 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.
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Deborah K Sullivan, PhD, RD, LD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

June 22, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 5, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003894
  • P30AG035982 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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