Clinical trial NCT06538324: Response to an Intervention With Omega-3 (RIO - Study)
Official title: Response to an Intervention With Omega-3 Fatty Acids on Lipid and Inflammatory Profile in Overweight and Hypertriglyceridemic Individuals in Valdivia, Chile (RIO - Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight
Hypertriglyceridemia
Keywords: Omega-3 fatty acids
Lipid profile
Inflammatory profile
Postprandial TG response
Lead sponsor: Universidad San Sebastián
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, controlled, double - blind, crossover study.
Primary purpose: PREVENTION

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 in overweight and hypertriglyceridemic individuals in Chile.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Fasting TG (mg/dL)
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Postprandial TG (mg/dL)
timeFrame: up to 6 weeks
measure: Change in mRNA expression levels of lipid metabolism genes in Peripheral Blood Mononuclear Cells (PBMCs)
timeFrame: up to 6 weeks
measure: Change in concentrations (pg/mL) of pro-inflammatory cytokines TNF-α and IL-6
timeFrame: up to 6 weeks
measure: Fasting serum Low-Density Lipoproteins, High-Density Lipoproteins, Very Low-Density Lipoproteins (mg/dL)
timeFrame: up to 6 weeks
measure: Fasting plasma glucose concentration (mg/dL)
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Valdivia
country: Chile
facility: Universidad San Sebastián
state: Los Ríos
Study officials:
References: