Universidad San Sebastián
Valdivia, Los Ríos Region, 5090000, Chile
NCT Number: NCT06538324
The RIO-Study project is a randomized, controlled, double-blind, crossover trial aimed at determining the effectiveness of omega-3 fatty acids at nutritional doses on lipid metabolism and inflammation in overweight and obese individuals with hypertriglyceridemia in Chile.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Valdivia, Los Ríos Region, 5090000, Chile
The study will include 40 participants (each participant will serve as their own control) aged 18-65, with 25-34.9 kg/m2 BMI and fasting triglycerides (TG) of 100-215 mg/dL. The intervention consists of 250 mg EPA from algae oil versus high oleic sunflower oil (HOSO) for 6 weeks each, after a 10-week washout period, the treatments will be switched for another 6 weeks, considering four visits during the whole study. The main outcomes to be evaluated are serum triglyceride levels, expression of target genes in peripheral blood mononuclear cells (PBMCs), low-grade inflammation biomarkers, and very low-density lipoprotein (VLDL) atherogenic properties. The study also analyzes background diet, chrononutrition, and physical activity aspects. Results are expected to provide new insights into the effects of nutritional doses of omega-3 in the Chilean population, particularly on fasting and postprandial triglyceride metabolism and cardiovascular disease risk reduction.
Before and after each intervention period, fasting blood samples will be collected. On each visit day, participants will consume a standardized breakfast (three slices of white bread with butter and jam), and postprandial blood samples will be taken at 0, 2, 4, and 6 hours to measure triglycerides and other lipid parameters.
The study will assess:
The study will collaborate with international partners for specialized analyses, including gene expression studies and VLDL atherogenic properties assessment.
This comprehensive approach aims to provide new insights into the effects of nutritional doses of omega-3 fatty acids on lipid metabolism and inflammation in the Chilean population, with a particular focus on postprandial triglyceride metabolism and cardiovascular disease risk reduction.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dietary Supplement: Omega-3 In the marine Omega-3 fatty acid period, the participants will receive a capsule with 250 mg of EPA per day during 6 weeks.
Dietary Supplement: HOSO In the HOSO period, the participants will receive a capsule with the similar weight of HOSO per day during 6 weeks.
Time frame: up to 6 weeks
Baseline serum levels of circulating triglycerides
Time frame: up to 6 weeks
Triglyceride concentration (mg/dL) measured by enzymatic colorimetric assay at baseline (fasting) and at 2, 4, and 6 hours after consumption of a standardized 50 g fat meal.
Time frame: up to 6 weeks
Fold change in mRNA expression of genes of lipid metabolism in PBMCs at 0h and 4h, measured by RT-qPCR
Time frame: up to 6 weeks
Serum concentrations (pg/mL) of tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) measured by enzyme-linked immunosorbent assay (ELISA) at fasting (0h) and 4 hours postprandial following a standardized test meal
Time frame: up to 6 weeks
Fasting levels before and after intake of omega-3 or HOSO
Time frame: up to 6 weeks
Fasting levels before and after intake of omega-3 or HOSO
Universidad San Sebastián
Other
Response to an Intervention With Omega-3 Fatty Acids on Lipid and Inflammatory Profiles in Overweight and Obese Individuals With Hypertriglyceridemia in Valdivia, Chile (RIO - Study)
Acronym: RIO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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