None listed
Conditions
Brief summary
Postprandial (post-meal consumption) blood triglyceride level has emerged as a clinically relevant risk factor for the development of cardiovascular disease. It is normal for postprandial triglycerides to rise after a fat-rich meal, however, elevated and excessive postprandial plasma triglyceride levels are associated with several cardio-metabolic events such as the formation of atherosclerosis. Long chain omega 3 fatty acids (eicosapentanoic acid and docosahexaenoic acid) are established triglyceride lowering agents which are primarily obtained from marine sources or fish oil. Medium chain fatty acids (MCFA, 6-12 carbon atoms) derived from coconut oil have been shown to lower triglyceride levels and raise HDL-cholesterol compared to long-chain saturated fatty acids in preclinical studies. The purpose of this trial is to investigate the combination of a single dose of dietary MCFA (coconut oil) and LCn-3PUFA (fish oil) on the post-meal rise in blood triglyceride levels in healthy individuals.
Interventions
Participants will visit the Nutraceuticals clinical research facility after an overnight fast of at least 10 hours. Participants are provided with a 'Participant Information Statement', 'Consent Form' and 'Letter of Instructions to prepare for clinic appointments' (including other questionnaires) prior to their first clinic appointment. These documents outline how to fast. Participants are also sent a reminder email 1 week prior to each appointment as well as a text message the afternoon before
Participants will visit the Nutraceuticals clinical research facility after an overnight fast of at least 10 hours. Participants are provided with a 'Participant Information Statement', 'Consent Form' and 'Letter of Instructions to prepare for clinic appointments' (including other questionnaires) prior to their first clinic appointment. These documents outline how to fast. Participants are also sent a reminder email 1 week prior to each appointment as well as a text message the afternoon before each appointment to remind them to commence their fast and at what time in order to ensure adherence to the 10 hour fast period. Following arrival, study participants will be randomly allocated to a single dose of these treatment arms (50g isocaloric dispersible powders containing active and/or placebo ingredients) delivered via a standardised meal on four visit days (once/week). 1. Olive oil + Tallow (PL): containing no fish oil (0g EPA & DHA) or coconut oil (0g MCFA) 2. Fish oil + Coconut oil (FO-CO): 18.65g coconut oil (15g MCFA), 6g fish oil (3g EPA & DHA) 3. Fish oil + Tallow oil (FO): 6g fish oil (3g EPA & DHA), 0g coconut oil (0g MCFA) 4. Coconut oil + Olive oil (CO): 18.65g coconut oil (15g MCFA) Standardised meal includes: 160g tub of Greek Style Yoghurt, 1 slice of wholemeal bread (toasted), 14g berry jam, 1 medium cavendish banana and 200mL water. The isocaloric powders are mixed into the yoghurt for consumption. Participants receive treatments with a washout period of one week. The standardised meal enriched with the isocaloric powders will be provided to the participants by the study investigator and the participants are instructed to consume the meal within 10 minutes.
Sponsors
University of Newcastle
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 70 Years
Healthy volunteers
Yes
Inclusion criteria
• Healthy male or female • Aged between 18 and 70 years
Exclusion criteria
• BMI > 40 kg/m2 • Pregnant or breast feeding • Taking hypolipidaemic medications (e.g. Lipitor, Crestor, Zocor) • Taking regular dietary supplements known to influence blood lipid levels (e.g. fish oil, fibre, curcumin) • Dieting or have any eating disorders • Strong allergies/intolerances/sensitivities to any of the food products or ingredients used in the study • History of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerotic CVD; or pulmonary disease • A chronic inflammatory disease (e.g. cancer) • Diabetes Mellitus (Type 1 and Type 2) • Liver or kidney related diseases • Fasting triglyceride levels higher than 3.0 mmol/L • History of gastrointestinal disorder and gall bladder disease • Smoke • History of severe neurological diseases or seizures • Pace maker implants • Vegetarian or vegan • Exercise more than 30minutes/d on four or more days of the week
Outcome results
None listed