Effect of Omega-3 on Lipid Metabolism in Overweight Individuals
Response to an Intervention With Omega-3 Fatty Acids on Lipid and Inflammatory Profile in Overweight and Hypertriglyceridemic Individuals in Valdivia, Chile (RIO - Study)
This study is testing if taking omega-3 from algae oil can help overweight adults improve their fat levels and reduce inflammation in their bodies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universidad San Sebastián Academic / other |
| Locations | 1 site (Valdivia, Los Ríos) |
| Trial ID | NCT06538324 on ClinicalTrials.gov |
What this trial studies
The RIO-Study is a randomized, controlled, double-blind, crossover trial designed to evaluate the impact of omega-3 fatty acids on lipid metabolism and inflammation in overweight and hypertriglyceridemic adults in Chile. It will involve 60 participants aged 18-65, who will receive either omega-3 from algae oil or high oleic sunflower oil for 6 weeks, followed by a washout period and a switch in treatments. Key outcomes include changes in serum triglyceride levels, gene expression related to lipid metabolism, and inflammatory biomarkers, assessed through fasting and postprandial blood samples. The study also considers dietary habits and physical activity to provide a comprehensive understanding of omega-3's effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a BMI between 25-29.9 kg/m2 and fasting triglyceride levels between 100-199 mg/dL.
Not a fit: Patients with uncontrolled metabolic diseases, significant weight fluctuations, or those on certain lipid-altering medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of triglyceride levels and reduced cardiovascular disease risk in overweight individuals.
How similar studies have performed: Previous studies have shown promising results with omega-3 fatty acids in improving lipid profiles, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults between 18 and 65 years old, male and female. * Body mass index (BMI) between 25 - 29,9 kg/m2. * Fasting triglycerides between 100 - 199 mg/dL (\>1.7 - 2,25 mmol/L). Exclusion Criteria: * Unable to give informed consent. * If you consume Omega-3 (you must stop consumption at least 10 weeks prior). * Normal or Obesity Nutritional Status. Large weight variation (\>10%) in the last 3 months. * Triglycerides \> 200 mg/dL. * Blood pressure \> 140/90 mmHg. * Uncontrolled metabolic and chronic diseases (reference parameters for the disease in question will be considered). * Pregnant women or those who are breastfeeding. * Allergy or intolerance to gluten, milk protein and/or lactose, or any ingredient in the capsules (omega-3, oleic acid oil). * Use of medications that affect lipid metabolism: Fibrates. (Statins will be allowed only if the treatment has been ongoing for over 3 months). * Blood donation two months before or during the study period. * Excessive alcohol consumption (\>3 cans of beer per day) * Taking anticoagulants.
Where this trial is running
Valdivia, Los Ríos
- Universidad San Sebastián — Valdivia, Los Ríos, Chile (Recruiting)
Study contacts
- Study coordinator: Viviana P Sandoval, Phd
- Email: info@rio-study.com
- Phone: 56927028967
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.