None listed
Conditions
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.
Interventions
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 a
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.
Sponsors
Macquarie University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed