OverweightRIONCT06538324
Response to an Intervention With Omega-3 (RIO - Study)
A study testing Omega-3 and HOSO in people with Overweight and Hypertriglyceridemia, run by Universidad San Sebastián at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Hypertriglyceridemia
- What is being tested?
- Omega-3 and HOSO
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- 30 Jul 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Response to an Intervention With Omega-3 Fatty Acids on Lipid and Inflammatory Profiles in Overweight and Obese Individuals With Hypertriglyceridemia in Valdivia, Chile (RIO - Study)
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.
Read the 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 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:
- Serum triglyceride levels in fasting and postprandial states
- 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
- Levels of low-grade inflammation biomarkers Tumor Necrosis Factor-Alpha (TNFα) and Interleukin 6 ( IL-6) at fasting (0h) and postprandial (4h) states
- 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.
- Conditions
- Overweight, Hypertriglyceridemia
- Being tested
- Omega-3, HOSO
- Keywords
- Omega-3 fatty acids, Lipid profile, Inflammatory profile, Postprandial TG response
- Medical subject headings
- Overweight, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary 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.
HOSODietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: HOSO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting TG (mg/dL)
Baseline serum levels of circulating triglycerides
Measured: up to 6 weeks
Secondary outcomes (5)
Postprandial TG (mg/dL)
Triglyceride concentration (mg/dL) measured by enzymatic colorimetric assay at baseline (fasting) and at 2, 4, and 6 hours after consumption of a standardized 50 g fat meal.
Measured: up to 6 weeks
Change in mRNA expression levels of lipid metabolism genes in Peripheral Blood Mononuclear Cells (PBMCs)
Fold change in mRNA expression of genes of lipid metabolism in PBMCs at 0h and 4h, measured by RT-qPCR
Measured: up to 6 weeks
Change in concentrations (pg/mL) of pro-inflammatory cytokines TNF-α and IL-6
Serum concentrations (pg/mL) of tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) measured by enzyme-linked immunosorbent assay (ELISA) at fasting (0h) and 4 hours postprandial following a standardized test meal
Measured: up to 6 weeks
Fasting serum Low-Density Lipoproteins, High-Density Lipoproteins, Very Low-Density Lipoproteins (mg/dL)
Fasting levels before and after intake of omega-3 or HOSO
Measured: up to 6 weeks
Fasting plasma glucose concentration (mg/dL)
Fasting levels before and after intake of omega-3 or HOSO
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start30 Jul 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, controlled, double - blind, crossover study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Sebastián
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viviana Sandoval, Universidad San Sebastián
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538324
- Sponsor's protocol ID
- CEC -USS N°42-24
- Acronym
- RIO
- Status last verified
- Jun 2025
- First submitted
- 10 Jul 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to an Intervention With Omega-3 Fatty Acids on Lipid and Inflammatory Profiles in Overweight and Obese Individuals With Hypertriglyceridemia in Valdivia, Chile (RIO - Study)
- ClinicalTrials.gov ID
- NCT06538324
- Acronym / sponsor ID
- RIO / CEC -USS N°42-24
- Conditions
- Overweight, Hypertriglyceridemia
- Keywords
- Omega-3 fatty acids, Lipid profile, Inflammatory profile, Postprandial TG response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad San SebastiánUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
- Serum triglyceride levels in fasting and postprandial states
- 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
- Levels of low-grade inflammation biomarkers Tumor Necrosis Factor-Alpha (TNFα) and Interleukin 6 ( IL-6) at fasting (0h) and postprandial (4h) states
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, double - blind, crossover study.
| Arm | Type | Receives |
|---|---|---|
| Marine Omega-3 fatty acid supplement | Experimental | Dietary Supplement: Omega-3Participants 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. |
| High-oleic sunflower oil (HOSO) containing no EPA or other omega-3 fatty acid | Placebo comparator | Dietary Supplement: HOSOParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3Dietary 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. | Dietary supplement | Marine Omega-3 fatty acid supplement |
| HOSODietary Supplement: HOSO In the HOSO period, the participants will receive a capsule with the similar weight of HOSO per day during 6 weeks. | Dietary supplement | High-oleic sunflower oil (HOSO) containing no EPA or other omega-3 fatty acid |
Primary outcome
Fasting TG (mg/dL)
Time frame: up to 6 weeks
Baseline serum levels of circulating triglycerides
5 secondary outcomes
Postprandial TG (mg/dL)
Time frame: up to 6 weeks
Change in mRNA expression levels of lipid metabolism genes in Peripheral Blood Mononuclear Cells (PBMCs)
Time frame: up to 6 weeks
Change in concentrations (pg/mL) of pro-inflammatory cytokines TNF-α and IL-6
Time frame: up to 6 weeks
Fasting serum Low-Density Lipoproteins, High-Density Lipoproteins, Very Low-Density Lipoproteins (mg/dL)
Time frame: up to 6 weeks
Fasting plasma glucose concentration (mg/dL)
Time frame: up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 and HOSO in people with Overweight and Hypertriglyceridemia, run by Universidad San Sebastián at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting TG (mg/dL) (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.