Cardiovascular DiseaseFISHDISHNCT01916434
Farmed Fish Human Intervention Study
A study testing High PUFA Salmon Fillets, Sustainable PUFA salmon and No salmon in people with Cardiovascular Disease, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- High PUFA Salmon Fillets, Sustainable PUFA salmon and No salmon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2013to Mar 2016
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion criteria: Healthy men and women aged 35-75 years BMI ranging from 18-35 kg/m2 Blood pressure below 160/90 mmHg; Total cholesterol < 8.00 mmol/L Total/HDL cholesterol < 6 mmol/L Fasting plasma glucose , 7 mmol/L Having a 10-20% risk for developing cardiovascular disease within the next 10 years based on the ASSIGN calculation (http://cvrisk.mvm.ed.ac.uk/index.htm) including the following factors: age, gender, number of cigarettes smoked per day, Scottish Index of Multiple Deprivation (SIMD)/postcode, systolic blood pressure, levels of total and HDL cholesterol and family history of cardiovascular disease, or having at least one additional risk factor such as being over 50 years old, BMI above 25 kg/m2, elevated triglyceride levels (> 1.7 mmol/L) or elevated glucose levels (> 5.6 mmol/L); platelet count > 1709/L haematocrit above 40 % for males and above 35 % for females haemoglobin above 130 g/L for males and above 115 g/L for females
Exclusion criteria Regularly taking aspirin or aspirin-containing drugs, or other anti-inflammatory drugs; Taking drugs or herbal medicines known to alter the haemostatic system in general; Taking any medicine known to affect lipid metabolism; Taking certain dietary supplements/multivitamin tablets; Diagnosis of diabetes, hypertension, renal, hepatic, haematological disease or coronary heart disease; Unsuitable veins for blood sampling; Inability to understand the participant information sheet; inability to speak, read and understand the English language.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rowett Institute of Nutrition and Health, Human Nutrition Unit
Aberdeen, AB21 9SB
About this study
Official title: FIsh for a Sustainable Healthy Diet In Scottish Households Study
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.
Read the detailed description
Aquaculture has the potential to take the pressure off wild fish stocks whilst meeting the dietary needs of the population for omega 3 fatty acids and other key nutrients such as vitamin D. The industry is working hard to improve sustainability - between 1995 and 2006 it has been estimated that the input to output ratios for salmon improved from 7.5 to 4.9 and trout from 6.0 to 3.4- but there is a need to do more. Reductions in fish stocks and catch quotas, in addition to sustainability considerations, mean that farmed fish may have to be raised on vegetable oils for example but this may reduce the omega 3 content and may affect the content of other nutrients. Fish are an important component of the diet and there is a need to understand the effect of pressures from sustainability on methods of production and the health giving properties of fish. We have now been commissioned by the Scottish Government's Rural and Environment Science and Analytical Services Division (RESAS) to do research on the health effects of Scottish farmed fish fed different feeding regimes in the Scottish population, and assess how differential effects in measured health outcomes could be related to fish composition.
Consumption of fish or omega-3- fatty acids from fish reduces coronary heart disease mortality, the leading cause of death in developed nations. The precise way in which fish provides benefit is not fully understood. This is important as fish and fish oils consist of a complex mixture of fatty acids and micronutrients that could individually, or collectively, be responsible for the beneficial effects. Aquaculture in Scotland is playing an increasingly important role in the provision of fish for human consumption, but issues with sustainability are requiring aquaculture to replace traditional fish oil and meal in formulated fish diets by oil from more sustainable sources, which may affect the levels of beneficial omega-3 fatty acids (EPA and DHA) and other components in fish. We will investigate the health effects of consuming two portions oily fish (Scottish farmed salmon) per week (current UK recommendation) using fish raised on different feeding regimes.
HYPOTHESIS
The health effects of consuming two portions oily fish (Scottish farmed salmon) per week (current UK recommendation) will be different for fish raised on different feeding regimes, primarily in terms of improving the omega-3 index.
OBJECTIVE
The main objective of this proposed study is to determine 1) whether the health benefits of consuming two portions of Scottish farmed salmon per week that have been fed a diet high in fish oil and fish meal significantly outweigh the health benefits of consuming two portions of Scottish farmed salmon per week that have been fed a diet with more sustainable levels of fish meal and fish oil, and 2) whether the difference in health benefits could justify the use of less sustainable dietary regimes for farmed fish.
- Conditions
- Cardiovascular Disease
- Being tested
- High PUFA Salmon Fillets, Sustainable PUFA salmon, No salmon
- 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
- Medical subject headings
- Cardiovascular Diseases, Thrombosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High PUFA Salmon FilletsOther
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.
Sustainable PUFA salmonOther
'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.
No salmonOther
The placebo group will continue to consume their habitual diet.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Sustainable PUFA salmon |
| No salmon | Placebo comparator | The placebo group will continue to consume their habitual diet Receives: Other: No salmon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and after 18 weeks salmon consumption
Secondary outcomes (1)
Change in cardiovascular risk markers
This study will include the measurement of standard risk markers of cardiovascular disease at the start, middle and end of the intervention period, including lipoprotein metabolism (total cholesterol, LDL cholesterol, HDL cholesterol) and metabolic markers (glucose, insulin, triglycerides and non-esterified fatty acids to calculate HOMA-IR and revised QUICKI). We will also measure 24-hrs ambulatory blood pressure.
Measured: At baseline, after 9 weeks and after 18 weeks salmon consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2016
- Study completionMar 2016
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 DiseaseStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baukje De Roos, Msc, PhD, Principal investigator, University of Aberdeen Rowett Institute of Nutrition and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916434
- Sponsor's protocol ID
- 2005
- Acronym
- FISHDISH
- Status last verified
- Mar 2016
- First submitted
- 2 Aug 2013
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33015732
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIsh for a Sustainable Healthy Diet In Scottish Households Study
- ClinicalTrials.gov ID
- NCT01916434
- Acronym / sponsor ID
- FISHDISH / 2005
- Conditions
- Cardiovascular Disease
- Keywords
- Farmed fish, Dietary intervention, Long-term intervention, Omega-3 index, Cardiovascular risk markers, Coagulation and endothelial activation, Bleeding time, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Aug 2013 (estimated)
- 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.
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.
Detailed description
Aquaculture has the potential to take the pressure off wild fish stocks whilst meeting the dietary needs of the population for omega 3 fatty acids and other key nutrients such as vitamin D. The industry is working hard to improve sustainability - between 1995 and 2006 it has been estimated that the input to output ratios for salmon improved from 7.5 to 4.9 and trout from 6.0 to 3.4- but there is a need to do more. Reductions in fish stocks and catch quotas, in addition to sustainability considerations, mean that farmed fish may have to be raised on vegetable oils for example but this may reduce the omega 3 content and may affect the content of other nutrients. Fish are an important component of the diet and there is a need to understand the effect of pressures from sustainability on methods of production and the health giving properties of fish. We have now been commissioned by the Scottish Government's Rural and Environment Science and Analytical Services Division (RESAS) to do research on the health effects of Scottish farmed fish fed different feeding regimes in the Scottish population, and assess how differential effects in measured health outcomes could be related to fish composition.
Consumption of fish or omega-3- fatty acids from fish reduces coronary heart disease mortality, the leading cause of death in developed nations. The precise way in which fish provides benefit is not fully understood. This is important as fish and fish oils consist of a complex mixture of fatty acids and micronutrients that could individually, or collectively, be responsible for the beneficial effects. Aquaculture in Scotland is playing an increasingly important role in the provision of fish for human consumption, but issues with sustainability are requiring aquaculture to replace traditional fish oil and meal in formulated fish diets by oil from more sustainable sources, which may affect the levels of beneficial omega-3 fatty acids (EPA and DHA) and other components in fish. We will investigate the health effects of consuming two portions oily fish (Scottish farmed salmon) per week (current UK recommendation) using fish raised on different feeding regimes.
HYPOTHESIS
The health effects of consuming two portions oily fish (Scottish farmed salmon) per week (current UK recommendation) will be different for fish raised on different feeding regimes, primarily in terms of improving the omega-3 index.
OBJECTIVE
The main objective of this proposed study is to determine 1) whether the health benefits of consuming two portions of Scottish farmed salmon per week that have been fed a diet high in fish oil and fish meal significantly outweigh the health benefits of consuming two portions of Scottish farmed salmon per week that have been fed a diet with more sustainable levels of fish meal and fish oil, and 2) whether the difference in health benefits could justify the use of less sustainable dietary regimes for farmed fish.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Pufa Salmon Fillets | Experimental | Other: High PUFA Salmon FilletsHigh 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. |
| Sustainable PUFA salmon | Experimental | Other: Sustainable PUFA salmon'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 |
| No salmon | Placebo comparator | Other: No salmonThe placebo group will continue to consume their habitual diet |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| High PUFA Salmon FilletsHigh 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'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 salmonThe placebo group will continue to consume their habitual diet. | Other | No salmon |
Primary outcome
Change in the omega-3 index
Time frame: At baseline and after 18 weeks salmon consumption
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.
1 secondary outcome
Change in cardiovascular risk markers
Time frame: At baseline, after 9 weeks and after 18 weeks salmon consumption
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 Mar 2016.
- Derived from this study: PubMed 33015732de 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.
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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.
Baukje De Roos, Msc, PhD principal investigator
University of Aberdeen Rowett Institute of Nutrition and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High PUFA Salmon Fillets, Sustainable PUFA salmon and No salmon in people with Cardiovascular Disease, run by University of Aberdeen 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?
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 Mar 2016. 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. 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?
Change in the omega-3 index (time frame: At baseline and after 18 weeks salmon consumption). 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 NCT01916434, 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 25 Mar 2016.