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 range18 Years – 65 Years
SexALL
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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.