None listed
Conditions
Brief summary
The aim of this study is to investigate the effects of single dose Prickly Pear (Opuntia ficus indica) fruit juice consumption, standardised for Total betalain Content (TBC), on CVD risk factors in postprandial blood lipids and physiological responses in healthy males. This double-blind placebo-controlled trial will model the potential blood lipid lowering effect of Prickly Pear fruit juice in combination with a ‘meal-model’ (high-fat muffin) on CVD risk factors in healthy humans.
Interventions
The aim of this study is to investigate the effects of single-dose Prickly Pear (Opuntia ficus indica; Australian grown) fruit juice consumption, standardised for Total betalain Content (TBC), on CVD risk factors in postprandial blood lipids and physiological responses in healthy males. This double-blind placebo-controlled trial, with wash-out period of a week, will model the potential blood lipid lowering effect of Prickly Pear fruit juice in combination with a ‘meal-model’ (high-fat muffin; Ki
The aim of this study is to investigate the effects of single-dose Prickly Pear (Opuntia ficus indica; Australian grown) fruit juice consumption, standardised for Total betalain Content (TBC), on CVD risk factors in postprandial blood lipids and physiological responses in healthy males. This double-blind placebo-controlled trial, with wash-out period of a week, will model the potential blood lipid lowering effect of Prickly Pear fruit juice in combination with a ‘meal-model’ (high-fat muffin; Kings College UK; consumed 10 min prior) on CVD risk factors in healthy humans. Dose: 250ml of Juice (45mg/TBC), with High-Fat muffin meal (691 KCAL;6.44 PRO; 50.4 FAT; 56.1 CHO; As per Kings College, UK) Duration: Single consumption, 2 clinics (randomised other: placebo) Form: Blinded juice, Liquid Delivery: Face to face, provided by Chief investigator, blinded to both CI and participant Location: Certified Blood Collection Room, University of Canberra, Australia
Sponsors
Faculty of Health
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Participants will be included if they are: male; aged between 18-65; a BMI of 18.5-25; no history of cardiovascular disease or known risk factors of CVD (i.e. high cholesterol, high blood pressure, diabetes, obesity, physical inactivity and history of smoking), hepatic, gastrointestinal or renal diseases; not allergic or intolerant to dairy, egg, wheat (gluten), maize (corn); and do not adhere to vegetarian (no egg and/or dairy) or vegan diets.
Exclusion criteria
Recruited participants are to be excluded under the following circumstances, to ensure the participants safety. Exclusion Criteria Participants will be excluded from the study if they are; not with in a BMI of 18.5-25; have a history of cardiovascular disease; have self-reported/known risk factors of CVD (i.e. high cholesterol, high blood pressure, diabetes, obesity, physical inactivity and history of smoking), hepatic, gastrointestinal or renal diseases; use medications or supplements including antibiotics; lipid-lowering therapies such as; statins, fibrates (including clofibrate and ciprofibrate) and lipid-lowering therapies (ezetimibe, colesevelam, torcetrapib, avasimibe, implitapide, niacin aspirin and clopidogrel therapy, Angiotensin-Converting Enzyme (ACE/ABC) therapy) within the 6 weeks prior to clinic 1. Additionally, participants will be excluded in cases where participants are suffering with substance abuse or use tobacco products.
Outcome results
None listed