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OpenTrials
Completed

NCT Number: NCT02921672

Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mediterranean Diet

Other

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 3, 2016
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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