Therapeutic Diets in Alzheimer's Disease (TDAD)

University of Kansas

Status: Completed

Conditions: Alzheimer Disease

Treatments: Behavioral: Ketogenic Diet; Behavioral: Therapeutic Lifestyles Changes Diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03860792

STUDY00143457

Details and patient eligibility

About

By doing this study, researchers hope to learn how the ketogenic and Therapeutic Lifestyles Changes diets affect cognition in patients with Alzheimer's disease.

Enrollment: 84 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of AD by current McKhann et al. 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

• Resides in a nursing home or dementia special care unit, or cannot control diet
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Ketogenic Diet

Experimental group

Description:

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.

Treatment:

Behavioral: Ketogenic Diet

Therapeutic Lifestyles Changes Diet

Active Comparator group

Description:

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.

Treatment:

Behavioral: Therapeutic Lifestyles Changes Diet