CClinicalTrials.gg
CompletedNCT02921672Updated Feb 6, 2019

Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline

An interventional study of Mediterranean Diet in Alzheimer's Disease and Cognitive Impairment, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-06.

Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
65 Years and older
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Alzheimer's Disease
  • Cognitive Impairment
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In context

Alzheimer Disease

3,681 studies on the registry are indexed under Alzheimer Disease; 875 are open to participants now.

This study's enrollment of 30 is below the median of 70 across 2,809 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

University of Kansas Medical Center is the lead sponsor of 484 studies on the registry; 113 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Serious medical risk
  • Adherence to specialized diet regimes
  • Already consume a Mediterranean diet pattern
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • OtherMediterranean Diet

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

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What researchers measure

Primary outcomes

  1. Number of participants completing the study

    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.

    Time frame: Week 6

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Study locations

1 site
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02921672
Lead sponsor
University of Kansas Medical Center
Collaborators
National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Oct 3, 2016
Start date
Mar 2016
Primary completion
Jun 22, 2018
Completion
Dec 2018
Last update
Feb 6, 2019

Study contacts

Deborah K Sullivan, PhD, RD, LD
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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