NCT06538324

Response to an Intervention With Omega-3 (RIO - Study)

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Universidad San Sebastián · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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: 1. Serum triglyceride levels in fasting and postprandial states 2. Expression of target genes Peroxisome proliferator-activated receptor alpha (PPARα) and Sterol regulatory element binding protein-1 (SREBP1c) in peripheral blood mononuclear cells (PBMCs) at fasting (0h) and postprandial (4h) states 3. Levels of low-grade inflammation biomarkers Tumor Necrosis Factor-Alpha (TNFα) and Interleukin 6 ( IL-6) at fasting (0h) and postprandial (4h) states 4. Very low-density lipoprotein (VLDL) atherogenic properties in the fasting state Additionally, the investigators will collect data on chrononutrition, physical activity, and energy drink intake to understand their impact on lipid metabolism. Anthropometric measurements and bioimpedance analysis will be performed at each visit. 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.

Conditions

• Overweight
• Hypertriglyceridemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega-3	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	Dietary Supplement: HOSO In the HOSO period, the participants will receive a capsule with the similar weight of HOSO per day during 6 weeks.

Timeline

• Start date: 2024-07-30
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2024-08-05
• Last updated: 2025-09-25

Locations

1 site across 1 country: Chile