Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline

NCT02921672 | Completed

• 2 other identifiers: STUDY00003894P30AG035982
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease; Cognitive Impairment

Outcome Measures

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.

  Week 6

Study Arms (3)

Cognitively Normal

ACTIVE COMPARATOR

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

Mild Cognitive Impairment

ACTIVE COMPARATOR

Persons diagnosed mild cognitive impairment (MCI). A registered dietician will meet with each person to discuss the Mediterranean Diet.

Other: Mediterranean Diet

Mild to Moderate Alzheimer's Disease

EXPERIMENTAL

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

Mediterranean Diet OTHER

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

Cognitively Normal; Mild Cognitive Impairment; Mild to Moderate Alzheimer's Disease

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Deborah K Sullivan, PhD, RD, LD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 3, 2016
• Study Start: March 1, 2016
• Primary Completion: June 22, 2018
• Study Completion: December 1, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)