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

NCT06538324 | Completed

• 1 other identifier: CEC -USS N°42-24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 obese individuals with hypertriglyceridemia in Chile.

Conditions

Overweight; Hypertriglyceridemia

Keywords

Omega-3 fatty acids; Lipid profile; Inflammatory profile; Postprandial TG response

Outcome Measures

Primary Outcomes (1)

• Fasting TG (mg/dL)

  Baseline serum levels of circulating triglycerides

  up to 6 weeks

Secondary Outcomes (5)

• Postprandial TG (mg/dL)

  up to 6 weeks

• Change in mRNA expression levels of lipid metabolism genes in Peripheral Blood Mononuclear Cells (PBMCs)

  up to 6 weeks

• Change in concentrations (pg/mL) of pro-inflammatory cytokines TNF-α and IL-6

  up to 6 weeks

• Fasting serum Low-Density Lipoproteins, High-Density Lipoproteins, Very Low-Density Lipoproteins (mg/dL)

  up to 6 weeks

• Fasting plasma glucose concentration (mg/dL)

  up to 6 weeks

Study Arms (2)

Marine Omega-3 fatty acid supplement

EXPERIMENTAL

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.

Dietary Supplement: Omega-3

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

PLACEBO COMPARATOR

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.

Dietary Supplement: HOSO

Interventions

Omega-3 DIETARY_SUPPLEMENT

Dietary Supplement: Omega-3 In the marine Omega-3 fatty acid period, the participants will receive a capsule with 250 mg of EPA per day during 6 weeks.

Marine Omega-3 fatty acid supplement

HOSO DIETARY_SUPPLEMENT

Dietary Supplement: HOSO In the HOSO period, the participants will receive a capsule with the similar weight of HOSO per day during 6 weeks.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad San Sebastián: lead

Study Sites (1)

Universidad San Sebastián

Valdivia, Los Ríos Region, 5090000, Chile

Location

Related Links

• RIO-Study web site

MeSH Terms

Conditions

Overweight; Hypertriglyceridemia

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The principal investigator will have exclusive access to the randomization code, which specifies the order of administration (either starting with HOSO or omega-3). This code is generated by an external statistician. The PI will ensure that the identical boxes containing capsules (both HOSO and Omega-3) are marked only with an Identification (ID). The randomization code will remain unknown to the participant, care provider, and outcomes assessor until after the primary outcome data has been analyzed.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher at the University San Sebastian

Model Details: Randomized, controlled, double - blind, crossover study.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: August 5, 2024
• Study Start: July 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-06

Locations

CL (1)