HealthyOmega 3-PTNCT05621083
Omega-3 Fatty Acids on Fasting and Postprandial Triglycerides (TG) Response - a Pilot Study
A study testing Omega- 3 and HOSO in people with Healthy, run by University of Oslo at 1 site in Norway.
Trial summary
The aim of this project is to elucidate how repeated exposure with omega-3 fatty acid supplementation for 6 weeks affect mean and individual fasting lipids and inflammatory responses and postprandial TG after a high fat meal with butter (50 g fat) in healthy subjects. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Omega- 3 and HOSO
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteNorway
- Study dates
- 11 Apr 2023to 31 Jan 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 18.5-30 kg/m2
- Fasting TG level at ≥0.9 mmol/L
- Max eating one portion of fatty fish per week.
- All subjects must be willing to take two capsules with either fish oil or HOSO.
- They all need to accept to avoid taking omega-3 supplementation.
- If they use omega-3 supplements, they should wait 12 weeks before starting the study.
Who cannot join
- Unable to give informed consent
- BMI <18.5 and >30 kg/m2
- Weight change of ± 5 % of body weight in the last three months
- TG <0.9 mmol/L and > 1.7 mmol/L
- C reactive protein (CRP) >10 mg/L
- Total cholesterol >6.9 mmol/L for subjects 30-49 years and >7.8 mmol/L for subjects ≥50 years old
Show all 17Show fewer
- Blood pressure >160/100 mm Hg
- Comorbidities including diabetes type I and II (blood glucose ≥7 mmol/L fasting), Cardiovascular diseases(CVD)/Coronary heart disease (CHD), haemophilia, anaemia (hemoglobin <120 gram/L), gastro intestinal disease, hyperthyroidism (TSH >4 Milliunits per litre (mU/L)) or inflammatory diseases such as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), polymyalgia and other connective tissue diseases.
- Pregnant or lactating
- Having CVD/CHD or cancer past 1 year
- Allergic or intolerant to gluten, milk protein and/or lactose
- Use of medications affecting lipids and lipid metabolism, blood clotting or inflammation.
- Unwilling to separate any use of omega-3 fatty acid supplements and other supplements during the study, and fish intake more than one portion per week, 12 weeks prior to and during the study period
- Hormone treatment (stabile dose of contraception or thyroxin for the last three months excepted)
- Use of medications affecting lipids and lipid metabolism, blood clotting or inflammation. Stable dose (more than 3 months) of statin, estrogen or blood pressure medications during the trial is allowed.
- Blood donation two months prior to or during the study period
- Tobacco smoking and snuff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Omega-3 Fatty Acids on Fasting and Postprandial TG Response in Healthy Subjects (Omega-3PT) - a Pilot Study
The aim of this project is to elucidate how repeated exposure with omega-3 fatty acid supplementation for 6 weeks affect mean and individual fasting lipids and inflammatory responses and postprandial TG after a high fat meal with butter (50 g fat) in healthy subjects.
Read the detailed description
The investigators aim to perform a randomized controlled crossover trial where each participant will act as his or her own control. Participants will be randomized to either start to receive fish oil (the omega-3 fatty acid supplement, dose of 2.3 g Eicosapentaenoic acid fatty acids (EPA) + Docosahexaenoic acid fatty acids (DHA) /day) for 6 weeks or a high-oleic sunflower oil (HOSO) containing no omega-3 fatty acids, as control followed by a wash-out period of minimum 12 weeks, before the treatment is changed for 6 weeks. Before and after each intervention period we will take fasting blood samples and collect spot morning urine. At home, the participant will perform a voluntary postprandial meal test with 61 g butter (containing 50 g fat), use DBS to collect fasting (0 h) 2, 4, 6, and 8 h blood samples after intake of the meal to measure TG which has been validated previously.
The investigators will use first part of the trial to define fasting and postprandial TG responders and non-responders. The investigators will also monitor at home the postprandial TG response to HOSO to see the participants' postprandial response to a control oil without omega-3 fatty acids. After a 12 week wash-out period, we will then repeat the fish oil intervention period once more for all in order to see if those we defined as responders continue to be defined in the same category in the repeated fish oil intervention (adaptive design). The investigators will collect exposure data, including dietary intake, physical activity, and clinical data such as BMI, body composition (such as fat mass, visceral fat, fat free mass), blood pressure, lipids and glucose and specific single nucleotide polymorphism (SNPs) to understand the impact of these factors on the individual postprandial TG response. In addition, the investigators will collect feces samples before taken before each meal test day for gut microbiota analysis.
- Conditions
- Healthy
- Being tested
- Omega- 3, HOSO
- Keywords
- Healthy Volunteers, Postprandial TG response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega- 3Dietary supplement
In the fish oil supplement period, the participants will receive concentrated fish oil which is equal to in total 2.3 g EPA+DHA per day during 6 weeks.
HOSODietary supplement
In the HOSO period, the participants will receive similar amount of HOSO per day during 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Fish oil (the omega-3 fatty acid supplement) | Experimental | Participants will be randomized to either start to receive fish oil (the omega-3 fatty acid supplement) for 6 weeks. Followed by a wash-out period of a minimum of 12 weeks before the treatment is changed.
Once the classical Randomized Controlled Trial (RCT) has finished, all the participants will repeat the fish oil intervention period (adaptive design) to determine if those the investigators defined as responders continue to be defined in the same category. Receives: Dietary Supplement: Omega- 3 |
| High-oleic sunflower oil (HOSO) containing no omega-3 fatty acids | Placebo comparator | Participants will be randomized to either start to receive high-oleic sunflower oil (HOSO) for 6 weeks. Followed by a wash-out period of minimum 12 weeks, before the treatment is changed. Receives: Dietary Supplement: HOSO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting TG
Baseline levels of circulating triglycerides
Measured: up to 6 weeks
Secondary outcomes (9)
Postprandial TG
At home, the participant will perform a voluntary postprandial meal test with 61 g butter (containing 50 g fat), use DBS to collect fasting(0 h) 2, 4, 6, and 8 h blood samples after intake of the meal
Measured: up to 6 weeks
Fasting cholesterol, free fatty acids (FFA), LDL cholesterol, high-density lipoprotein (HDL) cholesterol, Apo A1, Apo B, Apo B-48 and Apo C-III, and lipoprotein subclasses, glucose and insulin
measure fasting levels -compare fasting levels before and after intake of omega-3 or HOSO
Measured: up to 6 weeks
Fasting plasma cytokines, acute phase proteins and soluble adhesion molecules
measure fasting levels of all inflammatory markers before and after intake of omega-3 or HOSO
Measured: up to 6 weeks
Fasting whole genome Peripheral Blood Mononuclear Cells (PBMC) transcriptome (mRNA and miRNA)
fasting levels before and after intake of omega-3 or HOSO
Measured: up to 6 weeks
Fasting epigenome in PBMCs
fasting levels before and after intake of omega-3 or HOSO
Measured: up to 6 weeks
Fasting targeted and non-targeted metabolic profiling in plasma
fasting levels before and after intake of omega-3 or HOSO
Measured: up to 6 weeks
Targeted and untargeted metabolomics of spot urine to measure dietary intake biomarkers
Measure food intake metabolites in spot urine
Measured: up to 6 weeks
SNPs in whole blood
measure specific SNPs related to omega-3 intake and TG response
Measured: Measured once at baseline
Composition of the gut microbiome (both metabolites and bacteria composition)
measure metabolites in blood and feces and bacteria composition in feces
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 posted17 Nov 2022
- Study start11 Apr 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Start with control oil (HOSO) or start with fish oil, and then change after 12 weeks of wash out.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Throne-Holst Foundation for Nutrition Research, Horizon 2020 - European Commission, GC Rieber VivoMega AS
- Responsible party
- Principal investigator, Stine Marie Ulven, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621083
- Sponsor's protocol ID
- REK sør-øst B 482316
- Acronym
- Omega 3-PT
- Status last verified
- Mar 2025
- First submitted
- 2 Nov 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Omega-3 Fatty Acids on Fasting and Postprandial TG Response in Healthy Subjects (Omega-3PT) - a Pilot Study
- ClinicalTrials.gov ID
- NCT05621083
- Acronym / sponsor ID
- Omega 3-PT / REK sør-øst B 482316
- Conditions
- Healthy
- Keywords
- Healthy Volunteers, Postprandial TG response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Throne-Holst Foundation for Nutrition Research, Horizon 2020 - European Commission, GC Rieber VivoMega AS
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 17 Nov 2022 (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 aim of this project is to elucidate how repeated exposure with omega-3 fatty acid supplementation for 6 weeks affect mean and individual fasting lipids and inflammatory responses and postprandial TG after a high fat meal with butter (50 g fat) in healthy subjects.
Detailed description
The investigators aim to perform a randomized controlled crossover trial where each participant will act as his or her own control. Participants will be randomized to either start to receive fish oil (the omega-3 fatty acid supplement, dose of 2.3 g Eicosapentaenoic acid fatty acids (EPA) + Docosahexaenoic acid fatty acids (DHA) /day) for 6 weeks or a high-oleic sunflower oil (HOSO) containing no omega-3 fatty acids, as control followed by a wash-out period of minimum 12 weeks, before the treatment is changed for 6 weeks. Before and after each intervention period we will take fasting blood samples and collect spot morning urine. At home, the participant will perform a voluntary postprandial meal test with 61 g butter (containing 50 g fat), use DBS to collect fasting (0 h) 2, 4, 6, and 8 h blood samples after intake of the meal to measure TG which has been validated previously.
The investigators will use first part of the trial to define fasting and postprandial TG responders and non-responders. The investigators will also monitor at home the postprandial TG response to HOSO to see the participants' postprandial response to a control oil without omega-3 fatty acids. After a 12 week wash-out period, we will then repeat the fish oil intervention period once more for all in order to see if those we defined as responders continue to be defined in the same category in the repeated fish oil intervention (adaptive design). The investigators will collect exposure data, including dietary intake, physical activity, and clinical data such as BMI, body composition (such as fat mass, visceral fat, fat free mass), blood pressure, lipids and glucose and specific single nucleotide polymorphism (SNPs) to understand the impact of these factors on the individual postprandial TG response. In addition, the investigators will collect feces samples before taken before each meal test day for gut microbiota analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Start with control oil (HOSO) or start with fish oil, and then change after 12 weeks of wash out.
| Arm | Type | Receives |
|---|---|---|
| Fish oil (the omega-3 fatty acid supplement) | Experimental | Dietary Supplement: Omega- 3Participants will be randomized to either start to receive fish oil (the omega-3 fatty acid supplement) for 6 weeks. Followed by a wash-out period of a minimum of 12 weeks before the treatment is changed. Once the classical Randomized Controlled Trial (RCT) has finished, all the participants will repeat the fish oil intervention period (adaptive design) to determine if those the investigators defined as responders continue to be defined in the same category. |
| High-oleic sunflower oil (HOSO) containing no omega-3 fatty acids | Placebo comparator | Dietary Supplement: HOSOParticipants will be randomized to either start to receive high-oleic sunflower oil (HOSO) for 6 weeks. Followed by a wash-out period of minimum 12 weeks, before the treatment is changed. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body mass index (BMI) between 18.5-30 kg/m2
- Fasting TG level at ≥0.9 mmol/L
- Max eating one portion of fatty fish per week.
- All subjects must be willing to take two capsules with either fish oil or HOSO.
- They all need to accept to avoid taking omega-3 supplementation.
Key exclusion criteria (17 listed)
- Unable to give informed consent
- BMI <18.5 and >30 kg/m2
- Weight change of ± 5 % of body weight in the last three months
- TG <0.9 mmol/L and > 1.7 mmol/L
- C reactive protein (CRP) >10 mg/L
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- 3In the fish oil supplement period, the participants will receive concentrated fish oil which is equal to in total 2.3 g EPA+DHA per day during 6 weeks. | Dietary supplement | Fish oil (the omega-3 fatty acid supplement) |
| HOSOIn the HOSO period, the participants will receive similar amount of HOSO per day during 6 weeks. | Dietary supplement | High-oleic sunflower oil (HOSO) containing no omega-3 fatty acids |
Primary outcome
Fasting TG
Time frame: up to 6 weeks
Baseline levels of circulating triglycerides
9 secondary outcomes
Postprandial TG
Time frame: up to 6 weeks
Fasting cholesterol, free fatty acids (FFA), LDL cholesterol, high-density lipoprotein (HDL) cholesterol, Apo A1, Apo B, Apo B-48 and Apo C-III, and lipoprotein subclasses, glucose and insulin
Time frame: up to 6 weeks
Fasting plasma cytokines, acute phase proteins and soluble adhesion molecules
Time frame: up to 6 weeks
Fasting whole genome Peripheral Blood Mononuclear Cells (PBMC) transcriptome (mRNA and miRNA)
Time frame: up to 6 weeks
Fasting epigenome in PBMCs
Time frame: up to 6 weeks
Fasting targeted and non-targeted metabolic profiling in plasma
Time frame: up to 6 weeks
Targeted and untargeted metabolomics of spot urine to measure dietary intake biomarkers
Time frame: up to 6 weeks
SNPs in whole blood
Time frame: Measured once at baseline
Composition of the gut microbiome (both metabolites and bacteria composition)
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 28 Mar 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 Healthy, run by University of Oslo at 1 site in Norway.
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 6 inclusion and 17 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 28 Mar 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 Norway. 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 (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 28 Mar 2025.