Cardiovascular PreventionYOU-FishNCT06729229
The YOU-Fish Study: Fish and Omega 3 Supplementation in Young Adults
A study testing Dietary Supplement/Vitamins in people with Cardiovascular Prevention, run by University of Ulster at 1 site in United Kingdom.
Trial summary
Cardiovascular disease (CVD) is one of the major causes of mortality, however, it is estimated that approximately 75% of all cases are preventable. Previous evidence has shown higher blood concentrations of n-3 polyunsaturated fatty acids (PUFAs) are associated with a lower risk of cardiovascular disease owing to… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Prevention
- What is being tested?
- Dietary Supplement/Vitamins
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Nov 2024to 31 Jul 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Omega 3 index <6% Healthy males or females.
- Aged 18-30 years old.
- Low consumers of fish (<2 portions/month).
- Willing to 2 portions (280 grams) of fish per week.
- Not consuming fish oil supplements.
- Not consuming protein supplements.
- Within a BMI of 18-30kg/m2
- Not allergic to seafood
Who cannot join
- Omega 3 index >6%
- Regularly consume fish.
- Are allergic to seafood.
- Are taking fish oil supplements (for example fish oil, cod oil, krill oil, GLA or evening primrose) or are taking protein supplements (for example whey protein).
- Are pregnant/lactating.
- Have existing health conditions such as Diabetes Mellitus and known hypertension.
- Dietary restrictions resulting in the exclusion of fish such as vegan.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NICHE, School of Biomedical Sciences, Biomedical Sciences Research Institute, Coleraine Campus, University of Ulster
Coleraine, Co Londonderry, BT52 1SA
About this study
Official title: The YOU-Fish Study: Exploring the Effects of Fish Consumption and Omega 3 Supplementation on the Vascular Health of Young Adults
Cardiovascular disease (CVD) is one of the major causes of mortality, however, it is estimated that approximately 75% of all cases are preventable. Previous evidence has shown higher blood concentrations of n-3 polyunsaturated fatty acids (PUFAs) are associated with a lower risk of cardiovascular disease owing to their ability to lower inflammation. The omega-3 index (O3I) is a commonly used marker of n-3 PUFA status, which refers to the percentage of n-3 long chain PUFAs (with respect to total fatty acids) in red blood cell membranes, with an O3I of >8% associated with the lowest risk of CVD. Concerningly it's estimated that most of the population have an O3I ranging from 4-5%. Fish is a rich source of polyunsaturated fatty acids (PUFA) and has been shown to be one of the main predictors of a higher O3I. Current guidelines recommend the consumption of 2 portions of fish per week; however, current UK and Irish intakes are well below the current recommendations, particularly amongst young people. Additionally, professional bodies have noted that a daily omega-3 supplement, providing approximately 500mg EPA + DHA per day, is beneficial in increasing omeag-3 intakes amongst those who may exclude dietary sources such as fish. The regular consumption of fish or omega 3 supplement use could help to increase the O3I, however, it remains unknown as to whether the guidance surrounding these methods are effective in reaching the recommended target of 8%. Early interventions such as increasing the O3I (throughfish and/or supplements) into a lower risk category may be an effective intervention in the prevention of CVD. This human intervention study will investigate the effects of omega 3 supplements and fish on the O3I and vascular health of young adults. It is hypothesised that increasing fish consumption or taking omega 3 supplements will increase the O3I and improve the vascular health of young adults.
Read the detailed description
Apparently healthy males and females aged between 18-30 years old and who are low consumers of fish and not regularly consuming fish oil, or protein supplements will be recruited. A blood spot will be taken as part of the screening process to ensure the participants have a low baseline O3I (less than 6%) and to confirm they are low fish consumers and are not taking any supplements containing n-3 PUFA. A 2x2 factorial design will explore the effects of consuming fish and omega-3 supplements on the O3I and health of young adults. Participants will be randomly allocated, by an independent researcher, to one of 4 intervention groups: (I) a fish meal and omega-3 supplement group, (ii) a fish meal and placebo supplement group, (iii) a control meal (no fish) and omega-3 supplement, or (iv) a control meal (no fish) group and placebo supplement. Participants in the dietary fish group will be asked to attend the HISU twice per week where they will receive two lunch dishes per week containing a total of 280g fish per week (based on SACN dietary advice, SACN, 2004) for 8 weeks (140g oily fish and 140g lean fish) whilst the participants in the control group will receive a control meal. Examples of fish lunches may include salmon with a side of salad or a fish pie. Participants allocated to receive a control meal will be asked to attend the HISU at Ulster University where they will be provided with a fish free lunch such as cottage pie or chicken with a side of salad. The PUFA composition of the fish will be determined.
Participants in the omega-3 supplement or the placebo control group will be asked to consume a daily 1g omega-3 supplement (400mg EPA + 200mg DHA) or a daily 1g control capsule for 8 weeks, respectively. The control capsules will contain corn oil to deliver a fatty acid composition similar to that of the UK diet. Participants will be blinded as to whether they have been allocated supplements or placebo control which will be flavoured with peppermint and asked to take the supplement during a high fat meal (e.g. dinner) to enhance bioavailability and reduce intervariability amongst participants.
Participants will be asked to attend a baseline and post intervention appointment at the HISU at Ulster University. Body height (stadiometer), weight and composition (TANITA scales) will be determined. A fasting blood sample and faecal sample will be obtained and stored until batch analysis. The study will investigate the impact of fish and omega-3 supplements on the omega-3 index (OmegaQuant), full lipid profile (Daytona clinical analyser), full blood profile and immune markers related to cardiovascular disease such as c-reactive protein (CRP) and tumour necrosis factor alpha (TNF-α), interferon gamma (IFN-γ) and interleukins (IL-1β, IL-2, IL-4, IL-6, IL-10) using validated immunoassays, and gut microbiota.
Participants will be invited to partake in a short focus group (lasting approximately 1 hour) and complete a short questionnaire at baseline and 8 weeks post intervention to ascertain consumer attitudes (knowledge, awareness, behaviours, and barriers) towardsfish consumption and supplement use and how these have changed as a result of completing the intervention study.
All statistical analyses will be completed per protocol and using intention-to-treat (ITT) analyses. The primary analysis will compare (1) all those randomised to the fish intervention versus all those not allocated to the fish intervention and (2) all those randomised to the omega-3 supplement versus all those not allocated to the omega-3 supplement. Analysis of covariance controlling for age, BMI, and baseline O3I will be used to determine the effect of the interventions.
In a fixed effects ANOVA (comparison of means), sample sizes of 5 in each of the 4 groups (20 in total) achieves 91% power to detect a difference of 2.0% in O3I change using the Tukey-Kramer (Pairwise) multiple comparison test at a 0.05 significance level. A higher number of participants tend to drop out post randomisation before starting the intervention and this tends to exceed the expected 10% drop out rates and result in an attrition rate closer to 20%. Given the lower sample size needed and the risk of potential dropouts, in order to ensure the required 5 participants complete each of the 4 treatment groups, 10 participants will be recruited per group leading to a total sample size of 40.
- Conditions
- Cardiovascular Prevention
- Being tested
- Placebo, Dietary Supplement/Vitamins
- Keywords
- Polyunsaturated fatty acids, Omega 3 index, fish, fish consumption, cardiovascular disease.
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Experimental - 2 portions of fish (280g) per week and placebo supplement (corn oil)
Dietary Supplement/VitaminsDietary supplement
Experimental - Control lunch (no fish) and omega 3 supplement
PlaceboDietary supplement
Placebo comparator - Control lunch (no fish) and placebo supplement
Dietary Supplement/VitaminsDietary supplement
Experimental - 2 portions of fish (280g) per week and omega 3 supplement
| Study group | Role | What they receive |
|---|---|---|
| Fish and Placebo | Experimental | Participants will receive 2 portions of fish (280g) Receives: Dietary Supplement: Placebo |
| No fish SUPPLEMENT | Experimental | Daily 1g omega-3 supplement Receives: Dietary Supplement: Dietary Supplement/Vitamins |
| No fish PLACEBO | Experimental | Placebo Receives: Dietary Supplement: Placebo |
| 2 fish portion | Experimental | Omega 3 supplement Receives: Dietary Supplement: Dietary Supplement/Vitamins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Omega 3 index measured as percentage
Assessed via Gas-Chromatography mass spectrometry
Measured: Change at 8 weeks from baseline
Secondary outcomes (1)
Polyunsaturated fatty acid status
mg/ml
Measured: Time frame: change at 8 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start11 Nov 2024
- Primary completion30 Jun 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular PreventionStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emeir McSorley, PhD, Principal investigator, Ulster University, Cromore Road, Coleraine, Co. Londonderry, BT521SA.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729229
- Sponsor's protocol ID
- REC/24/0005
- Acronym
- YOU-Fish
- Status last verified
- Jun 2026
- First submitted
- 15 Nov 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McMullan JE, Kumar RA, Yeates AJ, Allsopp PJ, Mulhern MS, van Wijngaarden E, Strain JJ, McSorley EM. Influence of Fish Consumption and omega-3 Supplementation on the omega-3 Index of Young Adults: A 2 x 2 Factorial Randomized Controlled Trial (YouFish Study). J Nutr. 2025 Dec;155(12):4345-4355. doi: 10.1016/j.tjnut.2025.10.010. Epub 2025 Oct 11.
PubMed 41082976
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The YOU-Fish Study: Exploring the Effects of Fish Consumption and Omega 3 Supplementation on the Vascular Health of Young Adults
- ClinicalTrials.gov ID
- NCT06729229
- Acronym / sponsor ID
- YOU-Fish / REC/24/0005
- Conditions
- Cardiovascular Prevention
- Keywords
- Polyunsaturated fatty acids, Omega 3 index, fish, fish consumption, cardiovascular disease.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 11 Dec 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.
Cardiovascular disease (CVD) is one of the major causes of mortality, however, it is estimated that approximately 75% of all cases are preventable. Previous evidence has shown higher blood concentrations of n-3 polyunsaturated fatty acids (PUFAs) are associated with a lower risk of cardiovascular disease owing to their ability to lower inflammation. The omega-3 index (O3I) is a commonly used marker of n-3 PUFA status, which refers to the percentage of n-3 long chain PUFAs (with respect to total fatty acids) in red blood cell membranes, with an O3I of >8% associated with the lowest risk of CVD. Concerningly it's estimated that most of the population have an O3I ranging from 4-5%. Fish is a rich source of polyunsaturated fatty acids (PUFA) and has been shown to be one of the main predictors of a higher O3I. Current guidelines recommend the consumption of 2 portions of fish per week; however, current UK and Irish intakes are well below the current recommendations, particularly amongst young people. Additionally, professional bodies have noted that a daily omega-3 supplement, providing approximately 500mg EPA + DHA per day, is beneficial in increasing omeag-3 intakes amongst those who may exclude dietary sources such as fish. The regular consumption of fish or omega 3 supplement use could help to increase the O3I, however, it remains unknown as to whether the guidance surrounding these methods are effective in reaching the recommended target of 8%. Early interventions such as increasing the O3I (throughfish and/or supplements) into a lower risk category may be an effective intervention in the prevention of CVD. This human intervention study will investigate the effects of omega 3 supplements and fish on the O3I and vascular health of young adults. It is hypothesised that increasing fish consumption or taking omega 3 supplements will increase the O3I and improve the vascular health of young adults.
Detailed description
Apparently healthy males and females aged between 18-30 years old and who are low consumers of fish and not regularly consuming fish oil, or protein supplements will be recruited. A blood spot will be taken as part of the screening process to ensure the participants have a low baseline O3I (less than 6%) and to confirm they are low fish consumers and are not taking any supplements containing n-3 PUFA. A 2x2 factorial design will explore the effects of consuming fish and omega-3 supplements on the O3I and health of young adults. Participants will be randomly allocated, by an independent researcher, to one of 4 intervention groups: (I) a fish meal and omega-3 supplement group, (ii) a fish meal and placebo supplement group, (iii) a control meal (no fish) and omega-3 supplement, or (iv) a control meal (no fish) group and placebo supplement. Participants in the dietary fish group will be asked to attend the HISU twice per week where they will receive two lunch dishes per week containing a total of 280g fish per week (based on SACN dietary advice, SACN, 2004) for 8 weeks (140g oily fish and 140g lean fish) whilst the participants in the control group will receive a control meal. Examples of fish lunches may include salmon with a side of salad or a fish pie. Participants allocated to receive a control meal will be asked to attend the HISU at Ulster University where they will be provided with a fish free lunch such as cottage pie or chicken with a side of salad. The PUFA composition of the fish will be determined.
Participants in the omega-3 supplement or the placebo control group will be asked to consume a daily 1g omega-3 supplement (400mg EPA + 200mg DHA) or a daily 1g control capsule for 8 weeks, respectively. The control capsules will contain corn oil to deliver a fatty acid composition similar to that of the UK diet. Participants will be blinded as to whether they have been allocated supplements or placebo control which will be flavoured with peppermint and asked to take the supplement during a high fat meal (e.g. dinner) to enhance bioavailability and reduce intervariability amongst participants.
Participants will be asked to attend a baseline and post intervention appointment at the HISU at Ulster University. Body height (stadiometer), weight and composition (TANITA scales) will be determined. A fasting blood sample and faecal sample will be obtained and stored until batch analysis. The study will investigate the impact of fish and omega-3 supplements on the omega-3 index (OmegaQuant), full lipid profile (Daytona clinical analyser), full blood profile and immune markers related to cardiovascular disease such as c-reactive protein (CRP) and tumour necrosis factor alpha (TNF-α), interferon gamma (IFN-γ) and interleukins (IL-1β, IL-2, IL-4, IL-6, IL-10) using validated immunoassays, and gut microbiota.
Participants will be invited to partake in a short focus group (lasting approximately 1 hour) and complete a short questionnaire at baseline and 8 weeks post intervention to ascertain consumer attitudes (knowledge, awareness, behaviours, and barriers) towardsfish consumption and supplement use and how these have changed as a result of completing the intervention study.
All statistical analyses will be completed per protocol and using intention-to-treat (ITT) analyses. The primary analysis will compare (1) all those randomised to the fish intervention versus all those not allocated to the fish intervention and (2) all those randomised to the omega-3 supplement versus all those not allocated to the omega-3 supplement. Analysis of covariance controlling for age, BMI, and baseline O3I will be used to determine the effect of the interventions.
In a fixed effects ANOVA (comparison of means), sample sizes of 5 in each of the 4 groups (20 in total) achieves 91% power to detect a difference of 2.0% in O3I change using the Tukey-Kramer (Pairwise) multiple comparison test at a 0.05 significance level. A higher number of participants tend to drop out post randomisation before starting the intervention and this tends to exceed the expected 10% drop out rates and result in an attrition rate closer to 20%. Given the lower sample size needed and the risk of potential dropouts, in order to ensure the required 5 participants complete each of the 4 treatment groups, 10 participants will be recruited per group leading to a total sample size of 40.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fish and Placebo | Experimental | Dietary Supplement: PlaceboParticipants will receive 2 portions of fish (280g) |
| No fish SUPPLEMENT | Experimental | Dietary Supplement: Dietary Supplement/VitaminsDaily 1g omega-3 supplement |
| No fish PLACEBO | Experimental | Dietary Supplement: PlaceboPlacebo |
| 2 fish portion | Experimental | Dietary Supplement: Dietary Supplement/VitaminsOmega 3 supplement |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Omega 3 index <6% Healthy males or females.
- Aged 18-30 years old.
- Low consumers of fish (<2 portions/month).
- Willing to 2 portions (280 grams) of fish per week.
- Not consuming fish oil supplements.
Key exclusion criteria (7 listed)
- Omega 3 index >6%
- Regularly consume fish.
- Are allergic to seafood.
- Are taking fish oil supplements (for example fish oil, cod oil, krill oil, GLA or evening primrose) or are taking protein supplements (for example whey protein).
- Are pregnant/lactating.
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 |
|---|---|---|
| PlaceboExperimental - 2 portions of fish (280g) per week and placebo supplement (corn oil) | Dietary supplement | Fish and Placebo |
| Dietary Supplement/VitaminsExperimental - Control lunch (no fish) and omega 3 supplement | Dietary supplement | 2 fish portion |
| PlaceboPlacebo comparator - Control lunch (no fish) and placebo supplement | Dietary supplement | No fish PLACEBO |
| Dietary Supplement/VitaminsExperimental - 2 portions of fish (280g) per week and omega 3 supplement | Dietary supplement | No fish SUPPLEMENT |
Primary outcome
Omega 3 index measured as percentage
Time frame: Change at 8 weeks from baseline
Assessed via Gas-Chromatography mass spectrometry
1 secondary outcome
Polyunsaturated fatty acid status
Time frame: Time frame: change at 8 weeks from baseline
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 1 Jul 2026.
- Derived from this study: PubMed 41082976McMullan JE, Kumar RA, Yeates AJ, Allsopp PJ, Mulhern MS, van Wijngaarden E, Strain JJ, McSorley EM. Influence of Fish Consumption and omega-3 Supplementation on the omega-3 Index of Young Adults: A 2 x 2 Factorial Randomized Controlled Trial (YouFish Study). J Nutr. 2025 Dec;155(12):4345-4355. doi: 10.1016/j.tjnut.2025.10.010. Epub 2025 Oct 11.
- Individual participant dataSharing planned: No
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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.
Emeir McSorley, PhD principal investigator
Ulster University, Cromore Road, Coleraine, Co. Londonderry, BT521SA.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement/Vitamins in people with Cardiovascular Prevention, run by University of Ulster at 1 site in United Kingdom.
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 8 inclusion and 7 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 1 Jul 2026. 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 United Kingdom. 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. 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?
Omega 3 index measured as percentage (time frame: Change at 8 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06729229, which also lists 1 linked publication.
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 1 Jul 2026.