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

Universidad San Sebastián

Status: Enrolling

Conditions: Overweight; Hypertriglyceridemia

Treatments: Dietary Supplement: Omega-3; Dietary Supplement: HOSO

Study type: Interventional

Funder types: Other

Identifiers

NCT06538324

CEC -USS N°42-24

Details and patient eligibility

About

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 hypertriglyceridemic individuals in Chile.

Full description

The study will include 60 participants (each participant will serve as their own control) aged 18-65, with 25-34.9 kg/m2 BMI and fasting triglycerides (TG) of 100-199 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Marine Omega-3 fatty acid supplement

Experimental group

Description:

Participants will be randomized to either star to receive a capsule/day with omega-3 fatty acid from 1g Nannochloropsis sp. microalga (250 mg of EPA) for 6 weeks. Followed by a wash-out period of 10 weeks.

Treatment:

Dietary Supplement: Omega-3

High-oleic sunflower oil (HOSO) containing no EPA or other omega-3 fatty acid

Placebo Comparator group

Description:

Participants will be randomized to either star to receive a placebo capsule/day with the same weight of high oleic sunflower oil -HOSO (with no EPA or other omega-3 fatty acid content), for 6 weeks. Followed by a wash-out period of 10 weeks.

Treatment:

Dietary Supplement: HOSO