Study Protocol and Baseline Cardiometabolic Characterization of the RIO-Study (Response to an Intervention with Omega-3): A Randomized, Double-Blind, Placebo-Controlled Crossover Trial on Lipid and Inflammatory Profiles in Overweight and Obese Adults with Hypertriglyceridemia in Valdivia, Chile
Abstract
Background: Cardiovascular diseases (CVDs) are the leading cause of morbidity and mortality worldwide, with metabolic syndrome and its risk factors contributing substantially to cases in Latin America. In southern Chile, obesity, dyslipidemia, and sedentary behavior are highly prevalent, yet comprehensive baseline data on these factors are scarce. Establishing regional cardiometabolic profiles is crucial to inform prevention strategies.
Objective: To describe the RIO-Study protocol and characterize the baseline cardiometabolic profile of adults from Valdivia, southern Chile.
Methods: The RIO-Study is a randomized, double-blind, placebo-controlled, crossover clinical trial evaluating the effects of nutritional doses of seaweed-derived omega-3 fatty acids on lipid metabolism, inflammation, and molecular lipid regulators in adults with overweight/obesity. The protocol includes a standardized high-fat breakfast challenge and repeated postprandial blood sampling to assess dynamic lipid responses. Screening procedures comprised blood pressure measurement, fasting blood sampling, body composition by bioelectrical impedance, and health and lifestyle questionnaires.
Results: Among screened participants, 91% presented overweight/obesity and 55% presented central adiposity, exceeding regional cardiometabolic risk thresholds (waist circumference ≥ 90 cm in men, ≥80 cm in women). Men exhibited higher waist circumference (100 ± 10.8 vs. 91.6 ± 11.9 cm), waist-to-hip ratio (0.99 ± 0.08 vs.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 90 participants or records.
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