Therapeutic Diets in Alzheimer's Disease (TDAD)
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|ClinicalTrials.gov Identifier: NCT03860792|
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : November 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Behavioral: Ketogenic Diet Behavioral: Therapeutic Lifestyles Changes Diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||All outcomes assessors are masked from participant group assignment.|
|Official Title:||Therapeutic Diets in Alzheimer's Disease|
|Actual Study Start Date :||October 29, 2019|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||November 2023|
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.
- Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Baseline, 12 Weeks ]Reaction time and accuracy will be assessed by a psychometrician using the Stroop test.
- Change in Clinical Dementia Rating (CDR) [ Time Frame: 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.
- Change in cerebral concentration of N-Acetylaspartate (NAA) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, 6 Weeks, 12 Weeks ]Severity of symptoms will be measured via a self-reported symptoms questionnaire, answered by participant study partners.
- Change in blood ketone levels induced by ketogenic diet [ Time Frame: Baseline, 6 Weeks, 12 Weeks ]We will measure serum beta-hydroxybutyrate levels.
- Proportion of days positive for urinary ketone production [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860792
|Contact: Jessica Keller, MSemail@example.com|
|Contact: Matthew Taylor, PHDfirstname.lastname@example.org|
|United States, Kansas|
|Clinical and Translational Science Unit||Recruiting|
|Fairway, Kansas, United States, 66205|