Status:
COMPLETED
Response to an Intervention With Omega-3 (RIO - Study)
Lead Sponsor:
Universidad San Sebastián
Conditions:
Overweight
Hypertriglyceridemia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06538324
Start Date
July 30 2024
End Date
June 30 2025
Last Update
September 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Universidad San Sebastián
Valdivia, Los Ríos Region, Chile, 5090000