Journal Article Clinical Trial Protocol Epublish
PubMed: 41228467 DOI: 10.3390/nu17213397
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.
Nutrients 17(21)
Authors: Josefina Enríquez, Consuelo Quezada, Jessica Molina, Matías Sáez, Iarela Mitre, Camila Moreira, Feren Sandoval, Rodrigo Maldonado, Montserrat Fitó, Sebastián Zagmutt, Catalina Ramírez-Contreras, Eneko Ganuza, Álvaro Hernáez, Sergio Martínez-Huenchullán, Viviana Sandoval
Affiliations
- Carrera de Nutrición y Dietética, Facultad de Ciencias de la Rehabilitación y Calidad de Vida, Universidad San Sebastián, Valdivia 5090000, Chile.
- Departamento de Ciencias Básicas, Facultad de Ciencias, Universidad San Sebastián, Valdivia 5090000, Chile.
- Hospital del Mar Research Institute (HMRIB), 08003 Barcelona, Spain.
- CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, 28029 Madrid, Spain.
- Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Sant Cugat del Vallès, Spain.
- Departamento de Nutrición y Salud Pública, Facultad de Ciencias de la Salud y los Alimentos, Universidad del Bío-Bío, Chillán 3780000, Chile.
- Qualitas Health Inc. iwi life, Houston, TX 77056, USA.
- Blanquerna School of Health Sciences, University Ramon Llull, 08025 Barcelona, Spain.
- CIBER de Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, 28029 Madrid, Spain.
- Carrera de Kinesiología, Facultad de Ciencias de la Rehabilitación y Calidad de Vida, Universidad San Sebastián, Valdivia 5090000, Chile.
- Centro de Biología Celular y Biomedicina (CEBICEM), Facultad de Ciencias, Universidad San Sebastián, Santiago 8580000, 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. 0.92 ± 0.07), systolic blood pressure (130 ± 12.0 vs. 122 ± 13.4 mmHg), triglycerides (168 ± 84.7 vs. 122 ± 64.9 mg/dL), VLDL-C (33.7 ± 17.2 vs. 24.4 ± 13.0 mg/dL), and sedentary time (8.1 ± 2.3 vs. 6.8 ± 2.3 h/day). Women had greater total body fat (39.7 ± 4.75% vs. 31.1 ± 5.30%), higher HDL-C (56.6 ± 13.3 vs. 46.9 ± 9.39 mg/dL), and more often had normal weight (13% vs. 0%).
CONCLUSIONS
The RIO-Study provides novel insights into cardiometabolic risk and will elucidate the effects of nutritional omega-3 supplementation in a high-risk Chilean population.
MeSH
Blood, Dyslipidemias, Blood Pressure, Hypertriglyceridemia, Food, Obesity, Overweight, Waist Circumference