Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02921672

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease Cognitive Impairment	Other: Mediterranean Diet	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline

Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Jun 22, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

University of Kansas Medical Center
National Institute on Aging (NIA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT02921672

Other Study ID Numbers:

STUDY00003894
P30AG035982

First Posted:

Oct 3, 2016

Last Update Posted:

Feb 6, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Alzheimer Disease

Cognitive Dysfunction

Study Results

No Results Posted as of Feb 6, 2019