TDAD: Therapeutic Diets in Alzheimer's Disease
Study Details
Study Description
Brief Summary
By doing this study, researchers hope to learn how the ketogenic and Therapeutic Lifestyles Changes diets affect cognition in patients with Alzheimer's disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: Ketogenic Diet
Three-month 1:1 ketogenic diet intervention (approximately 70% fat, <10% carbohydrate, and 20% protein).
|
| Active Comparator: 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. |
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11) [Baseline, 12 Weeks]
Cognitive performance will be assessed by a psychometrician using the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11). The ADAS-Cog is an Alzheimer's disease specific, multi-domain cognitive assessment scored from 0-70 points with higher scores indicating poorer cognitive performance.
- Change in cognitive performance on the Mini-Mental State Exam (MMSE) [Baseline, 12 Weeks]
Global cognitive performance will be assessed by a psychometrician using the Mini-Mental State Exam (MMSE). The MMSE is a brief cognitive questionnaire with a maximum score of 30 points where higher scores indicate better cognitive performance.
- Change in cognitive performance on the Logical Memory Test (LMT) [Baseline, 12 Weeks]
The Logical Memory, subtest of the WMS-R is a standardized assessment of narrative episodic memory. A short story is orally presented, and the examinee is asked to recall the story immediately.
- Change in cognitive performance by Stroop test [Baseline, 12 Weeks]
Reaction time and accuracy will be assessed by a psychometrician using the Stroop test.
- Change in Clinical Dementia Rating (CDR) [Baseline, 12 Weeks]
The Clinical Dementia Rating is a 5-point scale (CDR 0, 0.5, 1, 2, and 3) used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias. CDR 0 indicates no dementia and higher values indicate more severe dementia. The scores of all six domains are averaged to form a global CDR score. Change in score from baseline to 3 months will be assessed.
Secondary Outcome Measures
- Change in cerebral concentration of N-Acetylaspartate (NAA) [Baseline, 12 Weeks]
Concentration of cerebral N-Acetylaspartate is measured using magnetic resonance spectroscopy in a 3T clinical scanner.
- Change in blood platelet mitochondrial function [Baseline, 6 Weeks, 12 Weeks]
Cytochrome c oxidase activity of blood platelets will be determined as a pseudo first order-rate constant (sec-1/mg protein) by measuring the oxidation of reduced cytochrome c at 550 nm.
- Change in self-reported symptoms by study partner [Baseline, 6 Weeks, 12 Weeks]
Severity of symptoms will be measured via a self-reported symptoms questionnaire, answered by participant study partners.
Other Outcome Measures
- Change in blood ketone levels induced by ketogenic diet [Baseline, 6 Weeks, 12 Weeks]
We will measure serum beta-hydroxybutyrate levels.
- Proportion of days positive for urinary ketone production [Daily for 90 days (the length of the diet intervention)]
Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany).
- Dietary intake characterization prior to and after ketogenic diet initiation [Baseline, 6 Weeks, 12 Weeks]
Changes in food and nutrient intake will be assessed by monthly 3-day food records completed by participant study partners.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of AD by current McKhann et al. criteria
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CDR global score of 0.5 or 1
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Agreed cooperation from an appropriate study partner
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Speaks English as primary language
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Age 50 to 90
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No medication changes within the past 30 days
Exclusion Criteria:
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Resides in a nursing home or dementia special care unit, or cannot control diet
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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.)
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Participating in another clinical trial or using an investigational drug or therapy within 30 days of the Screening Visit
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A history of renal stones
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical and Translational Science Unit | Fairway | Kansas | United States | 66205 |
Sponsors and Collaborators
- University of Kansas Medical Center
- National Institute on Aging (NIA)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00143457