Start: March 7, 2019
End: March 2023
What Is This Study About?
This study investigates how the Mediterranean diet and low-fat eating patterns affect cognitive function and other measures, such as brain volume and blood pressure, in cognitively normal older adults. Participants will be randomly assigned to either a Mediterranean or low-fat diet for one year. The Mediterranean diet consists of fruits, vegetables, grains, dairy, olive oil, seafood, and nuts. Additionally, participants will be randomized to take either 2 grams of an omega-3 fatty acid supplement or placebo. During the study, participants will track the food they eat, be monitored by a registered dietitian, and engage in monthly food demonstrations and cooking classes. They will also pick up a bag of groceries weekly for six months from a local grocery store. After one year, people may continue in the study for up to two years for additional measurements.
Do I Qualify To Participate in This Study?
- Cognitively normal (Mini-Mental State Examination score greater than 25; AD8 score of 2 or less; no prior diagnosis of mild cognitive impairment, Alzheimer's disease or dementia; and not medically treated for cognitive impairment or dementia)
- Speak English as a primary language
- Live in the Kansas City metropolitan area
- Body mass index of 20 to 40
Must NOT have:
- Serious medical risk, such as type 1 diabetes, cancer, or recent cardiac event, including heart attack or angioplasty
- Nut or fish allergy (does not include shellfish)
- Specialized diet, such as vegan
- Severe major depression or major psychiatric disorder that could interfere with study participation
- Alcohol abuse (more than 3 drinks per day or total of 18 per week) or drug abuse
- Do not have access to or independence over grocery shopping and meal preparation (for example, people living in a retirement community with reliance on dining facilities for meals)
- Already consume a Mediterranean or low-fat diet
- Prohibited medications: warfarin
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: University of Kansas Medical Center
National Institute on Aging (NIA)
Source: ClinicalTrials.gov ID: NCT03841539