The design of a crossover trial to study the effects of omega-3 fatty acids on Personal Post- Prandial TG response in healthy overweight subjects (Omega-3PT trial)
Cardiovascular diseases (CVDs) are the most common cause of death worldwide.Randomized controlled trials (RCT) have shown that marine omega-3 fatty acids reduce the risk of CVD, although inconsistent findings exist.The beneficial effects are predominantly mediated through the lowering of fasting triglycerides (TG) levels. Non-fasting TG levels are a significant risk factor for CVD, and omega-3 intake has been shown to affect postprandial TG levels. However, little is known about the inter-individual variation in the postprandial TG response after omega-3 fatty acids supplementation and the mechanisms. Thus, this trial aims to elucidate how omega-3 fatty acids supplementation affects postprandial lipid and inflammatory responses after a high-fat meal in healthy overweight subjects. We will perform a novel clinical trial in two phases: In which the first phase will be a classical RCT followed by a meal response. The participants will either take a control oil or 2g/d of marine omega-3 fatty acids from fish oil for six weeks with a 12-week wash-out period before changing the intervention. Before and after each treatment period, the fasted participants will be served a high-fat mixed meal containing 60 g of butter. Lipids, glucose, insulin and inflammatory markers, and PBMC gene expression, will be measured during the postprandial period, which last for 8 h. After the classical RCT, all participants will be supplemented with 2 g/d of marine omega-3 fatty acids for six weeks after a 12-week wash-out period followed by the meal response. This repeated exposure period offers the opportunity to define omega-3 responders and non-responders to understand individual variation in post-prandial TG levels better. We aim to recruit 52 healthy overweight male and female participants with fasting TG in the normal range (1-1.7 mmol/L). To better understand individual fasting and postprandial TG response, body composition, genetics, habitual dietary intake, chrono-nutrition, continuous glucose measurements, and physical activity will be determined before each visit. In addition, for future analyses, fecal samples will be collected for microbiota analyses and plasma for untargeted metabolomics analyses. This study seeks to generate new knowledge in precision nutrition to understand better why some people respond better to omega-3 fatty acids than others.
Keywords:
Personalized-nutrition/postprandial-response/triglycerides/lipid-metabolism.
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