Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001100189
Ethics application status
Approved
Date submitted
24/07/2019
Date registered
9/08/2019
Date last updated
9/08/2019
Date data sharing statement initially provided
9/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Coconut Oil in Alzheimer’s disease prevention 001 (COAD-P001)
Scientific title
Examine the effect of CocoMCT® on clinical factors related to health, cognition, quality of life and Alzheimer's disease (AD) in healthy volunteers – Tolerance study
Secondary ID [1] 296106 0
None
Universal Trial Number (UTN)
U1111-1220-6868
Trial acronym
COAD-P001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer’s disease 309681 0
Dementia 309683 0
Condition category
Condition code
Neurological 308490 308490 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitively healthy subjects, aged 50 to 80 years old, will consume increasing doses of medium chain triglycerides for 8 weeks. Doses will increase from 0 to 35mL in 5mL increments every week. Participants will consume the interventional product in liquid form using a measuring cup, each dose will be consumed 3 times daily for 1 week. Participants will attend our facilities once a week for the duration of the study. At every appointment, participants will have their anthropometric measurements and blood pressure taken, will donate venous and capillary blood samples and will complete questionnaires assessing their medical history, physical activity, dietary habits, cognition and quality of life. At each appointment participants will return their used and unused containiers and these will be used to monitor adherence to the intervention. Blood samples will be assessed for cardiovascular disease and Alzheimer's disease biomarkers. In addition, postprandial assessments will be done at each appointment. Participants will also consume the interventional product at each appointment and have their ketone and glucose levels assessed over 2 hours (fasting, 1 hour and 2 hours after food consumption). The response for each outcome at each time point will be compared to determine a safe and tolerable dose to be used in a long-therm study.
Intervention code [1] 312442 0
Prevention
Comparator / control treatment
This study is a dose comparison for the determination of the ideal dose of medium-chain triglycerides to be consumed in a long-term study. Doses will be compared with each other and with the baseline week, when no interventional product had been consumed. Doses to be compared are 5mL, 10mL, 15mL, 20mL, 25mL, 30mL and 35mL,
Control group
Dose comparison

Outcomes
Primary outcome [1] 307471 0
Side effects (number and severity)
Common side effects to MCT oils are loose bowel movements, increase in weight, stomach upset, bloating, diarrhoea-like symptoms, chest pains, nausea along with light headedness and dizziness. These side effects will be participant self-reported.
More serious side effects, which will be closely monitored, include increased liver enzymes, change in blood pressure, increased cholesterol levels, development of cardiovascular problems, allergic reactions. These side effects will be assessed at the participant weekly appointment and monitored using the blood tests and other assessment. Blood test assessments to determine safety include blood lipids (cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglycerides) and electrolytes and liver function tests (E'LFTs).
Timepoint [1] 307471 0
At baseline and after each dose (weekly for 8 weeks).
Primary outcome [2] 307495 0
Postprandial ketone levels.
For measuring this outcome participants will have their total blood ketone body levels measured fasting. They will then consume their morning dose of oil with their breakfast and 2 more blood samples will be collected (1 and 2 hours after breakfast). The postprandial levels determined for each dose will be compared.
Timepoint [2] 307495 0
At baseline and after each dose (weekly for 8 weeks).
Secondary outcome [1] 351998 0
Cognition
Cognition will be measured by a trained study staff personnel using a neuropsychological assessment battery developed by the study psychologist for this study.
Timepoint [1] 351998 0
At baseline and at the last appointment (in week 9, after 8 weeks of intervention).
Secondary outcome [2] 352069 0
Anthropometric measurements (weight, height, BMI, neck circumference, waist circumference and hip circumference). These are measured using a stadiometer, a scale and a measuring tape. This is a composite measure.
Timepoint [2] 352069 0
At baseline and after each dose (weekly for 8 weeks).
Secondary outcome [3] 352072 0
Plasma glucose
Measured by a pathology laboratory.
Timepoint [3] 352072 0
At baseline and after each dose (weekly for 8 weeks).
Secondary outcome [4] 370941 0
Alzheimer's disease biomarkers (plasma Aß, tau protein, brain derived necrosis factor). Biomarkers will be measured using Elisa kits. This is an exploratory outcome.
Timepoint [4] 370941 0
At baseline and after each dose (weekly for 8 weeks).
Secondary outcome [5] 373185 0
Compliance to the study protocol. This is a composite measure.
This will be measured using medical history along with changes to medications, physical activity and dietary habits.
Physical activity should not change during the study. No major changes should be done to dietary habits, only minor changes are expected to accommodate the increase in energy consumed.
Timepoint [5] 373185 0
At baseline and after each dose (weekly for 8 weeks).
Secondary outcome [6] 373187 0
Plasma insulin
Measured by a pathology laboratory.
Timepoint [6] 373187 0
At baseline and after each dose (weekly for 8 weeks).

Eligibility
Key inclusion criteria
- Males and females aged between 50-80 years.
- Participants must be able and willing to complete the study protocol.
- Participants must be able to provide written consent in English.
- Telephone-Montreal Cognitive Assessment (MOCA) with score equal or higher than 20.
- Participants must be cleared for the exclusion criteria.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. The investigator determines that the participant has not adequately understood the study procedures and may not have the ability to provide written informed consent at the time of the study entry
2. History of dementia including Alzheimer’s disease
3. Current or history of psychiatric or medical condition which in the opinion of the investigator may affect cognition
4. Significant gastrointestinal disorders including history of reflux, diarrhoea, constipation, irritable bowel syndrome, diverticular disease, chronic gastritis, severe gastroesophageal reflux which in the opinion of the investigator may aggravate the condition on study entry
5. Renal disease or insufficiency
6. Liver disease or insufficiency
7. Multiple sclerosis
8. Myocardial infarction within the last two years
9. History of high low density lipoprotein cholesterol levels (LDL-C higher than 5.0 mmol/L). History of cardiovascular disorders which in the opinion of the investigator may aggravate the condition on study entry
10. Uncontrolled hypertension
11. Diabetes Mellitus
12. Participants with known allergy to coconut or coconut oil
13. Participants consuming over the counter coconut oil as a health supplement at least 15 days prior to study entry
14. Participating in another clinical drug or device intervention trial within 30 days of their baseline visit.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
There will be no concealment. This is a sequential dose clinical intervention, all participants will consume all dose in a sequetial dose.
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
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis will be performed to determine the adequate dose of medium chain fatty acid oil to be consumed. The adequate dose will be determined by a function of tolerance and effect to biomarkers. The ideal dose will not affect adversely biomarkers for cardiovascular health and will cause the least side effects with the lowest severity or no side effects to at least 90% of the population studied.
IBM SPSS Statistics 19 software package will be used for the statistical analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/10/2018
Date of last participant enrolment
Anticipated
8/10/2019
Actual
Date of last data collection
Anticipated
10/12/2019
Actual
Sample size
Target
20
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13176 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 25730 0
2109 - Macquarie Park

Funding & Sponsors
Funding source category [1] 300692 0
University
Name [1] 300692 0
Macquarie University
Country [1] 300692 0
Australia
Funding source category [2] 300697 0
Commercial sector/Industry
Name [2] 300697 0
Chemrez Technologies Inc. (Philippines)
Country [2] 300697 0
Philippines
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University
1, 75 Talavera Road
NSW 2109, Sydney
Australia
Country
Australia
Secondary sponsor category [1] 300229 0
None
Name [1] 300229 0
Address [1] 300229 0
Country [1] 300229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301474 0
Macquarie University Human Research Ethics Comittee
Ethics committee address [1] 301474 0
Level 3, C5C Building
Macquarie University
NSW 2109, Australia
Ethics committee country [1] 301474 0
Australia
Date submitted for ethics approval [1] 301474 0
06/03/2018
Approval date [1] 301474 0
13/08/2018
Ethics approval number [1] 301474 0
5201833483834

Summary
Brief summary
A dietary intervention trial will be conducted in cognitively healthy subjects in sequential design. The trial will involve the consumption of increasing doses of a medium-chain triglyceride oil. Each dose will be consumed for 1 week and at the end of each dose period participants will donate blood samples, complete questionnaires and neuropsychological tests and have their anthropometric measurements and blood pressure taken. In addition, participants will complete a 3-day food records every week.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87138 0
Prof Ralph Martins
Address 87138 0
Macquarie University
1, 75 Talavera Road
Macquarie Park, NSW 2109
Australia
Country 87138 0
Australia
Phone 87138 0
+61 2 9850 4573
Fax 87138 0
Email 87138 0
[email protected]
Contact person for public queries
Name 87139 0
Dr Cintia Botelho Dias
Address 87139 0
Macquarie University
1, 75 Talavera Road
Macquarie Park, NSW 2109
Australia
Country 87139 0
Australia
Phone 87139 0
+61 02 98502782
Fax 87139 0
Email 87139 0
[email protected]
Contact person for scientific queries
Name 87140 0
Dr Cintia Botelho Dias
Address 87140 0
Macquarie University
1, 75 Talavera Road
Macquarie Park, NSW 2109
Australia
Country 87140 0
Australia
Phone 87140 0
+61 02 98502782
Fax 87140 0
Email 87140 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No Ethical aproval for IPD.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3415Ethical approval    376020-(Uploaded-24-07-2019-11-27-33)-Study-related document.pdf
3416Informed consent form    376020-(Uploaded-24-07-2019-11-29-28)-Study-related document.pdf



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.