Exploratory study of a ketogenic dietary supplement in dementia
| ISRCTN | ISRCTN39052741 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39052741 |
| Secondary identifying numbers | v1.1 |
- 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
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
Scientific
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
| rupert.mcshane@oxfordhealth.nhs.uk |
Study information
| Study design | Two centres phase 1 before-and-after case series |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ketone monoesters |
| Primary outcome measure | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 21/10/2013 |
| Completion date | 31/03/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
OX3 7JX
United Kingdom
Sponsor information
University/education
c/o Heather House
Clinical Trials and Research Governance Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
England
United Kingdom
| Website | http://www.ox.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
30/09/2016: No publications found, verifying study status with principal investigator
