Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline

NCT ID: NCT02921672

Last Updated: 2019-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Alzheimer's Disease Cognitive Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cognitively Normal

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

Group Type ACTIVE_COMPARATOR

Mediterranean Diet

Intervention Type OTHER

Diet consisting of fruits, vegetables, grains, dairy, olive oils, seafood, and nuts. It is low in red meat and solid fats.

Mild Cognitive Impairment

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

Group Type ACTIVE_COMPARATOR

Mediterranean Diet

Intervention Type OTHER

Diet consisting of fruits, vegetables, grains, dairy, olive oils, seafood, and nuts. It is low in red meat and solid fats.

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.

Group Type EXPERIMENTAL

Mediterranean Diet

Intervention Type OTHER

Diet consisting of fruits, vegetables, grains, dairy, olive oils, seafood, and nuts. It is low in red meat and solid fats.

Interventions

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Mediterranean Diet

Diet consisting of fruits, vegetables, grains, dairy, olive oils, seafood, and nuts. It is low in red meat and solid fats.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deborah K Sullivan, PhD, RD, LD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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P30AG035982

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00003894

Identifier Type: -

Identifier Source: org_study_id

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