Farmed Fish Human Intervention Study

NCT01916434 | Completed

• 1 other identifier: 2005
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Consumption of fish can help to prevent cardiovascular disease. The precise way in which fish is beneficial is not fully understood. This is important to find out as fish consists of a complex mixture of fatty acids and micronutrients such as vitamin D and selenium that could individually, or collectively, be responsible for the beneficial effects. Fish farming in Scotland is playing an increasingly important role in the provision of fish for human consumption. But issues with sustainability of raw materials are requiring fish farming to reformulate fish diets, which may affect the levels of beneficial omega-3 fatty acids and other components in fish. In this study we will be comparing the long-term health effects of eating two portions a week of Scottish salmon raised on a traditional fish diet versus eating two portions a week of Scottish salmon raised on a more sustainable fish diet. In addition, we will be looking at differences in health outcomes when eating two portions a week of either Scottish salmon, compared with eating no fish at all.

Conditions

Cardiovascular Disease

Keywords

Farmed fish; Dietary intervention; Long-term intervention; Omega-3 index; Cardiovascular risk markers; Coagulation and endothelial activation; Bleeding time; Inflammation; Oxidative stress; Gut health; Micronutrient availability

Outcome Measures

Primary Outcomes (1)

• Change in the omega-3 index

  The Omega-3 index will be measured by GC-MS. An optimal target level of the Omega-3 Index is 8%, and an undesirable level is less than 4%, with 4-8% being an intermediate-risk zone.

  At baseline and after 18 weeks salmon consumption

Secondary Outcomes (1)

• Change in cardiovascular risk markers

  At baseline, after 9 weeks and after 18 weeks salmon consumption

Other Outcomes (7)

• Bleeding time as measured by the platelet function analyzer (PFA-100)

  At baseline and after 18 weeks salmon consumption

• Markers of coagulation and endothelial activation.

  At baseline and after 18 weeks salmon consumption

• Markers of inflammation.

  At baseline and after 18 weeks salmon consumption

Study Arms (3)

High Pufa Salmon Fillets

EXPERIMENTAL

High EPA/DHA levels in feed and in salmon fillets (\~15% of total feed fatty acids, equal to wild salmon), 2 salmon fillets per week for 18 weeks, on top of habitual fish consumption.

Other: High PUFA Salmon Fillets

Sustainable PUFA salmon

EXPERIMENTAL

'Sustainable' levels of EPA/DHA in feed and in salmon fillets (\~6-8% of total feed fatty acids), 2 salmon fillets per week for 18 weeks, on top of habitual fish consumption

Other: Sustainable PUFA salmon

No salmon

PLACEBO COMPARATOR

The placebo group will continue to consume their habitual diet

Other: No salmon

Interventions

High PUFA Salmon Fillets OTHER

High EPA/DHA levels in feed and in salmon fillets (\~15% of total feed fatty acids, equal to wild salmon), 2 salmon fillets per week for 18 weeks, on top of habitual fish consumption.

High Pufa Salmon Fillets

Sustainable PUFA salmon OTHER

'Sustainable' levels of EPA/DHA in feed and in salmon fillets (\~6-8% of total feed fatty acids), 2 salmon fillets per week for 18 weeks, on top of habitual fish consumption.

Sustainable PUFA salmon

No salmon OTHER

The placebo group will continue to consume their habitual diet.

No salmon

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Rowett Institute of Nutrition and Health, Human Nutrition Unit

Aberdeen, AB21 9SB, United Kingdom

Location

Related Publications (1)

• de Roos B, Wood S, Bremner D, Bashir S, Betancor MB, Fraser WD, Duthie SJ, Horgan GW, Sneddon AA. The nutritional and cardiovascular health benefits of rapeseed oil-fed farmed salmon in humans are not decreased compared with those of traditionally farmed salmon: a randomized controlled trial. Eur J Nutr. 2021 Jun;60(4):2063-2075. doi: 10.1007/s00394-020-02396-w. Epub 2020 Oct 5.

  PMID: 33015732 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Thrombosis; Inflammation

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Baukje De Roos, Msc, PhD

  University of Aberdeen Rowett Institute of Nutrition and Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 5, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 25, 2016

Record last verified: 2016-03

Locations

GB (1)