The YOU-Fish Study: Fish and Omega 3 Supplementation in Young Adults

NCT06729229 | Not Yet Recruiting

• 1 other identifier: REC/24/0005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cardiovascular Prevention

Keywords

Polyunsaturated fatty acids; Omega 3 index; fish, fish consumption; cardiovascular disease.

Outcome Measures

Primary Outcomes (1)

• Omega 3 index measured as percentage

  Assessed via Gas-Chromatography mass spectrometry

  Change at 8 weeks from baseline

Secondary Outcomes (1)

• Polyunsaturated fatty acid status

  Time frame: change at 8 weeks from baseline

Other Outcomes (3)

• Inflammatory status

  Change at 8 weeks from baseline

• Lipid Profile

  Change at 8 weeks from baseline

• Microbiota

  Change at 8 wees from baseline

Study Arms (4)

Fish and Placebo

EXPERIMENTAL

Participants will receive 2 portions of fish (280g)

Dietary Supplement: Placebo

No fish SUPPLEMENT

EXPERIMENTAL

Daily 1g omega-3 supplement

Dietary Supplement: Dietary Supplement/Vitamins

No fish PLACEBO

EXPERIMENTAL

Placebo

Dietary Supplement: Placebo

2 fish portion

EXPERIMENTAL

Omega 3 supplement

Dietary Supplement: Dietary Supplement/Vitamins

Interventions

Placebo DIETARY_SUPPLEMENT

Experimental - 2 portions of fish (280g) per week and placebo supplement (corn oil)

Fish and Placebo

Dietary Supplement/Vitamins DIETARY_SUPPLEMENT

Experimental - Control lunch (no fish) and omega 3 supplement

2 fish portion

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Biological males and females will be recruited
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ulster: lead

Study Sites (1)

NICHE, School of Biomedical Sciences, Biomedical Sciences Research, Coleraine Campus, University of Ulster

Coleraine, Co Londonderry, BT52 1SA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 41082976 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Dietary Supplements; Vitamins

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients

Study Officials

• Emeir McSorley, PhD

  Ulster University, Cromore Road, Coleraine, Co. Londonderry, BT521SA.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emeir McSorley, PhD

CONTACT

+442870123543; Em.mcsorley@ulster.ac.uk

Alison J Yeates, PhD

CONTACT

442870123147; A.yeates@ulster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: December 11, 2024
• Study Start: December 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)