Exploratory study of a ketogenic dietary supplement in dementia

ISRCTN	ISRCTN39052741
DOI	https://doi.org/10.1186/ISRCTN39052741
Protocol serial number	v1.1
Sponsor	University of Oxford (UK)
Funder	University of Oxford

Submission date: 10/10/2013
Registration date: 05/11/2013
Last edited: 30/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The aims of this study are to examine the safety and tolerability of a ketone monoester in dementia, and to gather initial data on its effect on cognitive (thought) and motor (movement) function. The ketone monoester is rapidly broken down into a form which neurones (nerve cells) can use instead of glucose.

Who can participate?
Patients with moderate or severe dementia are eligible if they have a caregiver who can give good information about their behaviour and functioning.

What does the study involve?
All 24 patients will take the ketone monoester three times daily for a week. The first and last dose will be taken in the clinic and after cognitive and motor testing.

What are the possible benefits and risks of participating?
There are unlikely to be direct benefits from participation in a short one-week study.
Young healthy volunteers who took the product at substantially higher doses and in different formulations than in this study experienced some side effects like nausea, bloating and dizziness.

Where is the study run from?
The study is running in Oxford and Northamptonshire (UK).

When is the study starting and how long is it expected to run for?
It is anticipated that the study will start in October 2013 and is expected to run until March 2014.

Who is funding the study?
University of Oxford, UK.

Who is the main contact?
Dr Rupert McShane
rupert.mcshane@oxfordhealth.nhs.uk

Contact information

Dr Rupert McShane
Scientific

Warneford Hospital
Oxford
OX3 7JX
United Kingdom

Email	rupert.mcshane@oxfordhealth.nhs.uk

Study information

Primary study design	Interventional
Study design	Two centres phase 1 before-and-after case series
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title	Exploratory study of a ketogenic dietary supplement in dementia: a phase 1 pharmacokinetic and safety study
Study acronym	KETOCOG-01
Study objectives	That a ketone monoester drink will be tolerated; converted to safe levels of ketones; and not cause adverse events when taken three times daily for a week.
Ethics approval(s)	South West Wales Research Ethics Committee, 20/09/2013, ref: 13/WA/0267
Health condition(s) or problem(s) studied	Dementia
Intervention	All participants will receive oral 25g D-β-hydroxybutyrate-R 1,3 butanediol three times daily for a week. There are no control groups.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Ketone monoesters
Primary outcome measure(s)	1. Ketone levels 2. Adverse events 3. Tolerability 4. Change in Severe Impairment Battery (SIB) at 8 days 5. Clinician Interview Based Impression of Change (CIBIC+) Measured at baseline and one week only
Key secondary outcome measure(s)	1. Change in Alzheimers Disease Cooperative Study - Activities of Daily Living scale at 8 days 2. Change in Neuropsychiatric Inventory carer distress version (NPI) at 8 days 3. Change in Quality of Life measures at 8 days 4. Acute changes in cognitive tests: digit span, Executive Clock Drawing Task (CLOX), semantic fluency 5. Acute changes in fine and gross motor function: Peg Board, Get Up and Go Measured at baseline and one week only
Completion date	31/03/2014

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	24
Key inclusion criteria	1. Male or female, age over 70 years old 2. Has moderate or severe dementia 3. Able to walk 10 yards securely
Key exclusion criteria	1. Established stroke with residual weakness 2. English not first language 3. Unstable medical condition 4. Type 1 Diabetes mellitus
Date of first enrolment	21/10/2013
Date of final enrolment	31/03/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Warneford Hospital

Oxford
OX3 7JX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

30/09/2016: No publications found, verifying study status with principal investigator