Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000700437p
Ethics application status
Submitted, not yet approved
Date submitted
17/06/2025
Date registered
1/07/2025
Date last updated
1/07/2025
Date data sharing statement initially provided
1/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Medium chain triglyceride (MCT) supplementation in rural aged care residents: Phase 2a clinical trial
Scientific title
Medium chain triglyceride (MCT) supplementation in rural aged care residents to assess optimal dose and symptom management: Phase 2a clinical trial
Secondary ID [1] 313484 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive impairment 335895 0
Alzheimer's disease 335896 0
Condition category
Condition code
Neurological 332490 332490 0 0
Alzheimer's disease
Neurological 332491 332491 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The step-wedge trial will cover 3 phases over a 22-week period. The following phases include; 1) Routine Care, 2) Dose Optimisation, and 3) Stable Dose. This will be completed across 8 clusters, recruiting 5-6 participants per cluster.

PHASE 1: Routine care
During the routine care phase, the consented participants will be provided their usual care and will not be exposed to MCT supplementation. During this time all baseline measures will be collected the week prior to starting phase 2 (dose optimisation). The participant behaviour and stool chart history will be collected daily over the course of the routine care phase. Phase 1 duration will last between 1-8 weeks.

PHASE 2: Dose optimisation
Based on previous literature this phase will help optimise the MCT dose for every participant relative to their weight. All participants will complete a 10-week dose optimisation phase. The MCT supplement will be Bulletproof 360, Inc. Brain Octane C8 MCT Oil. It will be administered to participants twice a day, 50% with breakfast and 50% with dinner. The MCT is of a liquid oil consistency and will be administered separately, but at the same time as meals to minimise potential adverse events. The ml/kg value based on the standard molecular density of caprylic acid. – density 0.91 g/mL at 25 °C, which is the basis for all dosing calculations. This product has been approved for use in Canada and is registered in the Canadian Licenced Natural Health products Database; Natural Product Number: 80057199. This product has been used in a Canadian based randomised, double-blind, placebo-controlled crossover study for participants with probable Alzheimer’s Disease (1).

Briefly, the dose will begin as a 0.05g/kg dose and will increase each week by 0.05g/kg as tolerated by the participant. Provided no symptoms have been reported dosage increases will be reviewed weekly and will be ordered through each participants online medication chart on LeeCare. Dosage alterations will be actioned based on each participants tolerance of the MCT supplement, as reported daily by clinical staff within the LeeCare reporting system, considering their tolerance of the MCT and daily stool chart documentation. Previously reported symptoms indicative of MCT supplementation intolerance include gastrointestinal irritation, loose stools, nausea, cramping and abdominal discomfort. These symptoms have previously been reported with large sudden increases in dosing. The gradual increase in dose can help minimise symptoms and any potential unknown adverse events. The additional symptoms of ketosis can include constipation, headache, halitosis, muscle cramps, diarrhea, and general weakness and rash. These occur greatest between days 1–4 of a fast or ketogenic diet (2). Only mild ketosis is reported with MCT supplementation, it is expected that symptoms of ketosis will also be mild. In MCT the aforementioned MCT trials, symptoms being reported are the adverse events associated with the supplement and not ketosis. Previous trials in older adults applied a dose range of 20-56 g per day (3). Therefore, no dose will exceed 56 g per day for participants with high body weight.

Monitoring of adherence to the intervention will occur through access to the LeeCare digital health monitoring system.

Reference
1. Juby, A. G., Blackburn, T. E., & Mager, D. R. (2022). Use of medium chain triglyceride (MCT) oil in subjects with Alzheimer’s disease: A randomized, double-blind, placebo-controlled, crossover study, with an open-label extension. Alzheimer’s & Dementia: Translational Research & Clinical Interventions, 8(1), e12259-n/a. https://doi.org/10.1002/trc2.12259
2. Harvey, C. J. D. C., Schofield, G. M., & Williden, M. (2018). The use of nutritional supplements to induce ketosis and reduce symptoms associated with keto-induction: a narrative review. PeerJ, 6, e4488.
3. Juby, A. G., Brocks, D. R., Jay, D. A., Davis, C. M. J., & Mager, D. R. (2021). Assessing the impact of factors that influence the ketogenic response to varying doses of medium chain triglyceride (MCT) oil. The Journal of Prevention of Alzheimer's Disease, 8, 19-28.

PHASE 3: Stable dose
Participants will continue to receive their individualised tolerable stable dose of MCT until the completion of the trial at 22 weeks. Participants will continue to be monitored of weight, capillary ketones, blood pressure, heart rate, stool, and behaviour charts. Participants will be reviewed on a case-to-case basis by the clinical staff if they start to develop symptoms over the course of Phase 2. This could include, for mild symptoms, reducing the MCT dose to the previous titration each day until symptoms reduce or removing the MCT supplement from the diet if more severe symptoms are experienced. All symptoms over the cause of the trial will be documented and reported as the primary outcome.
Duration of phase 3 will vary from 4-11 weeks depending on which cluster participants are enrolled into.
Intervention code [1] 330058 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340017 0
Bowel Movements
Timepoint [1] 340017 0
Daily reporting for duration of trial during phases 1-3.
Primary outcome [2] 341926 0
Behaviour
Timepoint [2] 341926 0
Daily reporting for duration of trial during phases 1-3.
Primary outcome [3] 341927 0
Other Symptoms
Timepoint [3] 341927 0
Daily reporting during phases 2 and 3.
Secondary outcome [1] 442340 0
Cognition
Timepoint [1] 442340 0
Baseline, end of phase 2 and trial end
Secondary outcome [2] 442344 0
Medication usage
Timepoint [2] 442344 0
Baseline and trial completion
Secondary outcome [3] 442345 0
weight
Timepoint [3] 442345 0
Baseline, weekly during phase 2 (10 weeks), monthly during phase 3 until the end of the trial at 22 weeks.
Secondary outcome [4] 442347 0
Liver Function Tests
Timepoint [4] 442347 0
baseline, end of phase 2 and trial end.
Secondary outcome [5] 442348 0
Capillary ketones
Timepoint [5] 442348 0
Baseline, weekly during phase 2 (10 weeks), monthly during phase 3 until the end of the trial at 22 weeks.
Secondary outcome [6] 442349 0
Heart rate measurement
Timepoint [6] 442349 0
Baseline, weekly during phase 2 (10 weeks), monthly during phase 3 until the end of the trial at 22 weeks.
Secondary outcome [7] 449025 0
Blood pressure measurement
Timepoint [7] 449025 0
Baseline, weekly during phase 2 (10 weeks), monthly during phase 3 until the end of the trial at 22 weeks.
Secondary outcome [8] 449026 0
Lipid profile
Timepoint [8] 449026 0
baseline, end of phase 2 and trial end.
Secondary outcome [9] 449029 0
Cognition
Timepoint [9] 449029 0
Baseline, end of phase 2 and trial end
Secondary outcome [10] 449032 0
Appetite
Timepoint [10] 449032 0
Baseline, end of phase 2 and trial end
Secondary outcome [11] 449035 0
Physical Activity
Timepoint [11] 449035 0
Baseline, end of phase 2 and trial end

Eligibility
Key inclusion criteria
Permanently residing in at the Renmark Nursing Home based at the Renmark and Paringa District Hospital, RMCLHN
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Where life expectancy can be measured as less than 6 month, and the goals of care are comfort and the relief of symptoms
• Receiving Short term respite care
• Diagnosed with inflammatory bowel disease with regular bouts of diarrhoea that is not well controlled
• Diagnosed with a fatty acid oxidisation disorder
• Diagnosed with a pyruvate carboxylase deficiency
• Allergy or previous adverse reaction to coconut, as the product is pure coconut extract.
• Diagnosis of type 1 diabetes
• Diagnosis of Hepatic Cirrhosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The total length of the stepped wedge trial is 22 weeks. All participants will undergo the 10 week does optimisation in phase 2. Phase 1 and 3 will have varying lengths depending on which cluster the participants are enrolled into. This will minimise the potential burden during the dose optimisation phase onto the Nursing home staff who are providing care for the participants on a daily basis.
All participants will complete 22 weeks in the trial.
Phase 1 will vary from 1 to 8 weeks.
Phase 2 will be 10 weeks.
Phase 3 will vary from 4 to 11 weeks.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/07/2025
Actual
Date of last participant enrolment
Anticipated
28/07/2025
Actual
Date of last data collection
Anticipated
29/12/2025
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 43463 0
5341 - Renmark
Recruitment postcode(s) [2] 44237 0
5343 - Berri

Funding & Sponsors
Funding source category [1] 317924 0
Government body
Name [1] 317924 0
Riverland Mallee Coorong Local Health Network
Country [1] 317924 0
Australia
Primary sponsor type
Government body
Name
Riverland Mallee Coorong Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 320271 0
None
Name [1] 320271 0
Address [1] 320271 0
Country [1] 320271 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316609 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 316609 0
Ethics committee country [1] 316609 0
Australia
Date submitted for ethics approval [1] 316609 0
29/11/2024
Approval date [1] 316609 0
Ethics approval number [1] 316609 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138406 0
Prof Paul Worley
Address 138406 0
Riverland Mallee Coorong Local Health Network, PO Box 346, Murray Bridge SA 5253
Country 138406 0
Australia
Phone 138406 0
+61 08 8580 2402
Fax 138406 0
Email 138406 0
[email protected]
Contact person for public queries
Name 138407 0
Emily Mathews
Address 138407 0
Riverland Mallee Coorong Local Health Network, Maddern Street, Berri 5343
Country 138407 0
Australia
Phone 138407 0
+61 481 453 947
Fax 138407 0
Email 138407 0
[email protected]
Contact person for scientific queries
Name 138408 0
Amy Mendham
Address 138408 0
Riverland Mallee Coorong Local Health Network, Maddern Street, Berri 5343
Country 138408 0
Australia
Phone 138408 0
+61 448 626 034
Fax 138408 0
Email 138408 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.