Feasibility and Efficacy of the Ketogenic Diet in Alzheimer's Disease

NCT03690193 | Completed DMC

• 1 other identifier: 13796
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the KDRAFT study is to assess the feasibility and preliminary cognitive efficacy of a ketogenic diet therapy in patients with Alzheimer's disease.

Conditions

Alzheimer Disease

Keywords

Ketogenic Diet; Alzheimer's disease

Outcome Measures

Primary Outcomes (2)

• Proportion of days positive for urinary ketone production

  Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany).

  Daily for 90 days (the length of the diet intervention)

• Change in blood ketone levels induced by ketogenic diet

  Serum beta-hydroxybutyrate levels will be measured at five monthly study visits; baseline prior to diet initiation, three monthly collections during the ketogenic diet intervention, and after the 1-month washout return to a regular diet.

  Change from baseline serum beta-hydroxybutyrate levels at month 1, 2, 3 (end of ketogenic diet), and 4 (after 1-month washout).

Secondary Outcomes (3)

• Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog)

  Change from baseline global cognitive scores at month 3 (end of ketogenic diet) and change from month 3 global cognitive scores at month 4 (end of 1-month washout).

• Change in cognitive performance on the Mini-Mental State Exam (MMSE)

  Change from baseline global cognitive scores at month 3 (end of ketogenic diet) and change from month 3 global cognitive scores at month 4 (end of 1-month washout).

• Dietary intake characterization prior to and after ketogenic diet initiation

  Dietary intake will be collected at Baseline, Month 1, Month 2, Month 3

Study Arms (1)

Ketogenic Diet Arm

EXPERIMENTAL

All participants will be assigned to the 3-month ketogenic diet intervention. Study partners will be instructed to assist participants in adherence to a 1:1 ketogenic diet (approximately 70% fat, \<10% carbohydrate, and 20% protein). Participants will be provided medium chain triglyceride oil 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

Interventions

Ketogenic Diet BEHAVIORAL

All participants will be assigned to the 3-month 1:1 ketogenic diet intervention (approximately 70% fat, \<10% carbohydrate, and 20% protein).

Ketogenic Diet Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Alzheimer's disease (CDR 0.5, 1, \& 2)
• Active study partner
• BMI \> 21
• English speaking

You may not qualify if:

• BMI \< 21
• Consume greater than 14 drinks of alcohol per week
• Insulin Dependent Diabetes Mellitus
• Diagnosis of active cancer
• Myocardial infarction or symptoms of coronary artery disease (e.g. angina) in last year

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Related Publications (1)

• Taylor MK, Swerdlow RH, Burns JM, Sullivan DK. An Experimental Ketogenic Diet for Alzheimer Disease Was Nutritionally Dense and Rich in Vegetables and Avocado. Curr Dev Nutr. 2019 Feb 20;3(4):nzz003. doi: 10.1093/cdn/nzz003. eCollection 2019 Apr.

  PMID: 30931426 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Debra K Sullivan, PhD, RD, Chair and Endowed Professor of Clinical Nutrition

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: October 1, 2018
• Study Start: December 3, 2013
• Primary Completion: January 6, 2017
• Study Completion: January 6, 2017
• Last Updated: October 1, 2018

Record last verified: 2018-09