None listed
Conditions
Brief summary
Purpose of study Extra virgin olive oil, a key ingredient of the cardioprotective Mediterranean diet, is considered a healthy source of dietary fat due to its high content of monounsaturated fatty acids and antioxidant polyphenols. However, while consistent, promising evidence exists, the unique contribution of polyphenols to the cardioprotective effect of olive oil is not fully established. This study will examine the effect of high-polyphenol extra virgin olive oil versus low-polyphenol olive oil on markers of cardiovascular disease risk that are related to cholesterol metabolism and total antioxidant capacity as well as measures of cognitive function. Hypothesis: Compared with a low polyphenol olive oil, a high polyphenol olive oil intervention will result in improved measures of HDL cholesterol efflux and total antioxidant capacity in a healthy adult population. Objectives 1. Efficacy. Efficacy outcomes include HDL cholesterol efflux, total antioxidant capacity, cholesterol levels (total, HDL, LDL, triglycerides), cognitive performance, and blood pressure. 2. Safety. Safety outcomes include adverse and serious adverse events directly attributable to the intervention period. 3. Adherence. Adherence outcomes will include biomarkers related to monounsaturated fat intake, bottle count, self-report checklist, and patient interview.
Interventions
An extra virgin olive oil with a confirmed polyphenol count >300mg per kg. Participants will receive a 3-week supply of the high-polyphenol olive oil (1.3litres) and will be required to consume 60ml (3 tablespoons) per day for a three-week intervention phase. There will be a washout period of two weeks at the commencement of the study and between treatment arms.
Adherence will be measured by serum markers of fatty acid intake, diet diaries, and weighing the returned olive oil bottles at each 3
An extra virgin olive oil with a confirmed polyphenol count >300mg per kg. Participants will receive a 3-week supply of the high-polyphenol olive oil (1.3litres) and will be required to consume 60ml (3 tablespoons) per day for a three-week intervention phase. There will be a washout period of two weeks at the commencement of the study and between treatment arms. Adherence will be measured by serum markers of fatty acid intake, diet diaries, and weighing the returned olive oil bottles at each 3-week followup meeting.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Aged 18-75 years
Exclusion criteria
The exclusion criteria of "Post and peri-menopausal" women has been removed. More specifically the updated list of the key exclusion criteria is as follows: Non-English-speaking persons • Pregnant or lactating women • History of adverse reactions to olive oil ( • Currently prescribed warfarin, anti-coagulant therapy, statin medications, all oral hypoglycaemic agents, insulin, cyclosporine, tacrolimus, immunosuppressant agents, antihypertensive agents, and nonsteroidal anti-inflammatory drugs (hypothesised interactions), hormone replacement therapy • A habitual diet with greater than or equal to 1 tablespoon of olive oil per day; • Current smoker; • Use of antioxidant supplements or medications with antioxidant properties, • Diagnosed with any of the following conditions: hyperlipidaemia; diabetes mellitus; hypertension; inflammatory conditions (e.g. rheumatoid arthritis), intestinal disease (e.g. inflammatory bowel disease); irritable bowel syndrome, food intolerances, blood coagulation disorders, or any other physiological condition or disease that could impair adherence. -Unstable body weight within =/>5kg weight fluctuations in the prior 3 months -Special diet for medical reasons (i.e gluten free for coeliac disease) Exclusion criteria for cognition component only. -Currently prescribed antidepressant medication
Outcome results
None listed