Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2019-10-15
2025-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ketogenic Diet
Study partners will be instructed to assist participants in adherence to a 1:1 ketogenic diet (approximately 70% fat, \<10% carbohydrate, and 20% protein as energy). The diet will encourage ≥4 servings of non-starchy vegetables and 1/2 cup of berries daily. Participants will be provided an emulsified medium chain triglyceride supplement with a target intake of 1-2 tablespoons per day and micronutrient supplements consisting of multivitamin, vitamin D, calcium, and phosphorus. After the 3-month ketogenic diet, participants will complete a 1-month washout period in which they halt adherence to the ketogenic diet and resume their normal diet.
Ketogenic Diet
Three-month 1:1 ketogenic diet intervention (approximately 70% fat, \<10% carbohydrate, and 20% protein).
Therapeutic Lifestyles Changes Diet
Study partners will be instructed to assist participants in adherence to the Therapeutic Lifestyles Changes diet. The diet consists of 20-35% fat, 50-60% carbohydrate, and \~15% protein as energy. Fat intake will comprise \<7% saturated fat, ≤20% monounsaturated fat, and ≤10% polyunsaturated fat as total energy. Cholesterol consumption will be ≤200mg per day. Participants are encouraged to eat ≥2 servings of fruit and ≥5 servings of vegetables per day.
Therapeutic Lifestyles Changes Diet
Three-month diet intervention that is low in fat and cholesterol, high in fruits, vegetables, and whole grains, and moderate in protein.
Interventions
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Ketogenic Diet
Three-month 1:1 ketogenic diet intervention (approximately 70% fat, \<10% carbohydrate, and 20% protein).
Therapeutic Lifestyles Changes Diet
Three-month diet intervention that is low in fat and cholesterol, high in fruits, vegetables, and whole grains, and moderate in protein.
Eligibility Criteria
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Inclusion Criteria
* CDR global score of 0.5 or 1
* Agreed cooperation from an appropriate study partner
* Speaks English as primary language
* Age 50 to 90
* No medication changes within the past 30 days
Exclusion Criteria
* A potentially confounding serious medical risk including insulin-requiring diabetes, cancer requiring chemotherapy or radiation within the past 5 years, or a recent cardiac event (i.e. heart attack, angioplasty, etc.)
* Participating in another clinical trial or using an investigational drug or therapy within 30 days of the Screening Visit
* A history of renal stones
50 Years
90 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
University of Kansas Medical Center
OTHER
Responsible Party
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Russell Swerdlow
Professor
Locations
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Clinical and Translational Science Unit
Fairway, Kansas, United States
Countries
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Other Identifiers
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STUDY00143457
Identifier Type: -
Identifier Source: org_study_id