Response to an Intervention With Omega-3 (RIO - Study) (NCT06538324) | Clinical Trial Compass
CompletedNot Applicable
Response to an Intervention With Omega-3 (RIO - Study)
Chile40 participantsStarted 2024-07-30
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults between 18 and 65 years old, male and female.
* Body mass index (BMI) between 25 - 34,9 kg/m2.
* Fasting triglycerides between 100-215 mg/dL (1.13-2.43 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 \> 215 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.