Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline

Alzheimer's Disease Clinical Trial

Official title:

Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921672
• Other study ID #: STUDY00003894
• Secondary ID: P30AG035982
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: June 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognitive Dysfunction
• Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 6