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Therapeutic Diets in Alzheimer's Disease (TDAD)

Primary Purpose

Alzheimer Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketogenic Diet
Therapeutic Lifestyles Changes Diet
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinical and Translational Science UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketogenic Diet

Therapeutic Lifestyles Changes Diet

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11)
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)
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)
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
Reaction time and accuracy will be assessed by a psychometrician using the Stroop test.
Change in Clinical Dementia Rating (CDR)
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)
Concentration of cerebral N-Acetylaspartate is measured using magnetic resonance spectroscopy in a 3T clinical scanner.
Change in blood platelet mitochondrial function
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
Severity of symptoms will be measured via a self-reported symptoms questionnaire, answered by participant study partners.

Full Information

First Posted
February 28, 2019
Last Updated
September 27, 2023
Sponsor
University of Kansas Medical Center
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03860792
Brief Title
Therapeutic Diets in Alzheimer's Disease
Acronym
TDAD
Official Title
Therapeutic Diets in Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 29, 2019 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
All outcomes assessors are masked from participant group assignment.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketogenic Diet
Arm Type
Experimental
Arm 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.
Arm Title
Therapeutic Lifestyles Changes Diet
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Ketogenic Diet
Intervention Description
Three-month 1:1 ketogenic diet intervention (approximately 70% fat, <10% carbohydrate, and 20% protein).
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Lifestyles Changes Diet
Intervention Description
Three-month diet intervention that is low in fat and cholesterol, high in fruits, vegetables, and whole grains, and moderate in protein.
Primary Outcome Measure Information:
Title
Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11)
Description
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.
Time Frame
Baseline, 12 Weeks
Title
Change in cognitive performance on the Mini-Mental State Exam (MMSE)
Description
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.
Time Frame
Baseline, 12 Weeks
Title
Change in cognitive performance on the Logical Memory Test (LMT)
Description
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.
Time Frame
Baseline, 12 Weeks
Title
Change in cognitive performance by Stroop test
Description
Reaction time and accuracy will be assessed by a psychometrician using the Stroop test.
Time Frame
Baseline, 12 Weeks
Title
Change in Clinical Dementia Rating (CDR)
Description
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.
Time Frame
Baseline, 12 Weeks
Secondary Outcome Measure Information:
Title
Change in cerebral concentration of N-Acetylaspartate (NAA)
Description
Concentration of cerebral N-Acetylaspartate is measured using magnetic resonance spectroscopy in a 3T clinical scanner.
Time Frame
Baseline, 12 Weeks
Title
Change in blood platelet mitochondrial function
Description
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.
Time Frame
Baseline, 6 Weeks, 12 Weeks
Title
Change in self-reported symptoms by study partner
Description
Severity of symptoms will be measured via a self-reported symptoms questionnaire, answered by participant study partners.
Time Frame
Baseline, 6 Weeks, 12 Weeks
Other Pre-specified Outcome Measures:
Title
Change in blood ketone levels induced by ketogenic diet
Description
We will measure serum beta-hydroxybutyrate levels.
Time Frame
Baseline, 6 Weeks, 12 Weeks
Title
Proportion of days positive for urinary ketone production
Description
Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany).
Time Frame
Daily for 90 days (the length of the diet intervention)
Title
Dietary intake characterization prior to and after ketogenic diet initiation
Description
Changes in food and nutrient intake will be assessed by monthly 3-day food records completed by participant study partners.
Time Frame
Baseline, 6 Weeks, 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Keller, MS
Phone
913-588-5355
Email
kkali17@kumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Taylor, PHD
Phone
913-588-5363
Email
mtaylor3@kumc.edu
Facility Information:
Facility Name
Clinical and Translational Science Unit
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Therapeutic Diets in Alzheimer's Disease

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