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Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02921672
Recruitment Status : Completed
First Posted : October 3, 2016
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Cognitive Impairment Other: Mediterranean Diet Not Applicable

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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Study Type : Interventional  (Clinical Trial)
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 : March 2016
Actual Primary Completion Date : June 22, 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921672


Locations
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United States, Kansas
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
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Principal Investigator: Deborah K Sullivan, PhD, RD, LD University of Kansas Medical Center
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02921672    
Other Study ID Numbers: STUDY00003894
P30AG035982 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders