Back to resultsFeasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline
Primary Purpose
Alzheimer's Disease, Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mediterranean Diet
Sponsored by
About this trial
This is an interventional prevention trial for Alzheimer's Disease
Eligibility 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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Cognitively Normal
Mild Cognitive Impairment
Mild to Moderate Alzheimer's Disease
Arm Description
Persons who are considered to have normal cognitive function. A registered dietician will meet with each person to discuss the Mediterranean Diet.
Persons diagnosed mild cognitive impairment (MCI). A registered dietician will meet with each person to discuss the Mediterranean Diet.
Persons diagnosed with mild to moderate Alzheimer's disease (AD). A registered dietician will meet with each person to discuss the Mediterranean Diet.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02921672
First Posted
September 29, 2016
Last Updated
February 5, 2019
Sponsor
University of Kansas Medical Center
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT02921672
Brief Title
Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline
Official Title
Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 22, 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Cognitive Impairment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitively Normal
Arm Type
Active Comparator
Arm Description
Persons who are considered to have normal cognitive function. A registered dietician will meet with each person to discuss the Mediterranean Diet.
Arm Title
Mild Cognitive Impairment
Arm Type
Active Comparator
Arm Description
Persons diagnosed mild cognitive impairment (MCI). A registered dietician will meet with each person to discuss the Mediterranean Diet.
Arm Title
Mild to Moderate Alzheimer's Disease
Arm Type
Experimental
Arm Description
Persons diagnosed with mild to moderate Alzheimer's disease (AD). A registered dietician will meet with each person to discuss the Mediterranean Diet.
Intervention Type
Other
Intervention Name(s)
Mediterranean Diet
Intervention Description
Diet consisting of fruits, vegetables, grains, dairy, olive oils, seafood, and nuts. It is low in red meat and solid fats.
Primary Outcome Measure Information:
Title
Number of participants completing the study
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah K Sullivan, PhD, RD, LD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline
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