Polyunsaturated Fatty Acid (PUFA) StatusiFishNCT03765580
The Influence of Fish Consumption on Polyunsaturated Fatty Acid (PUFA) Status
A study testing Fish in people with Polyunsaturated Fatty Acid (PUFA) Status, run by University of Ulster at 1 site in United Kingdom.
Trial summary
Polyunsaturated fatty acids (PUFA) are important for health, for example for the immune system, heart health and the brain. PUFA are found in fish, nuts and oils; including these foods in the diet provides the body with PUFA. The body can also produce some PUFA in a series of steps. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polyunsaturated Fatty Acid (PUFA) Status
- What is being tested?
- Fish
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2016to 31 May 2017
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy females - premenopausal, child-bearing age, not planning to become pregnant
- Age 18-45years old
- Low consumers of fish (<2 portions/ week) or those willing to reduce their fish consumption one month prior to commencing the study to the equivalent of 2 portions per month or less
- Willing to eat 1 or 2 portions (140 grams or 280 grams) of either tuna or sardines per week for a period of 8 weeks
- Not consuming fish oil supplements
- Not consuming protein supplements
- Not allergic to seafood
Who cannot join
- Regularly eat fish or not willing to do washout period where they reduce fish consumption
- Are allergic to seafood
- Are taking fish oil supplements or are taking protein supplements
- Are pregnant or menopausal
- Have very short hair (a small section of hair, approximately 200 strands, will be taken at the nap of the neck for analysis purposes)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Intervention Studies Unit, Ulster University
Coleraine, Co.Londonderry, BT52 1SA
About this study
Official title: The Influence of Fish Consumption on Polyunsaturated Fatty Acid (PUFA) Status (iFish Study)
Polyunsaturated fatty acids (PUFA) are important for health, for example for the immune system, heart health and the brain. PUFA are found in fish, nuts and oils; including these foods in the diet provides the body with PUFA. The body can also produce some PUFA in a series of steps. It has been found that genetics influences the levels of PUFA produced in the body. This study will investigate whether fish consumption influences PUFA status in women of childbearing age when accounting for FADS genotype by conducting a controlled human intervention study. Participants will be asked to consume none, one or two portions of oily fish per week for 8 weeks and their response in PUFA status measured. This study will also use collected blood, hair, urine and faecal samples collected from the intervention study to explore other biomarkers of fish consumption. The aim of this study is to investigate whether fish consumption influences PUFA status in women of childbearing age when accounting for FADS genotype and to explore the potential of a novel biomarker, using hair MeHg:δ34S values, to accurately predict fish consumption. The study will initially involve providing a buccal swab sample which will investigate genes which are related to fatty acids. The participant will provide a buccal swab sample so that their genotype can be determined. The researcher who will contact the participant once genotype has been determined to arrange a baseline appointment. Participants will attend the Human Intervention Studies Unit at Ulster University, Coleraine once or twice weekly for a period of 8 weeks where they will receive lunch. This lunch will contain either tuna, sardines, or no fish depending on the intervention group you will be allocated to. Examples of lunch time meals they may receive include sandwiches, baked potato or salad which will include the type of fish they have been allocated to receive. Those allocated to the no fish group will receive a fish free alternative lunch. Participants will be asked to continue to follow their normal diet and lifestyle over the intervention period of 8 weeks. All participants will attend a baseline and post intervention appointment where they will have weight, height and body composition measured. Participants will also complete questionnaires to provide medical, lifestyle and dietary information. All participants will be asked to provide a sample of blood, urine, hair and faeces to assess biomarkers of fish consumption at baseline and post intervention appointments. Collected blood, urine, hair and faecal samples will be analysed for biomarkers of fish consumption. Participants will also be asked to return to the Human Intervention Studies Unit (HISU) 8 weeks after the intervention study has been completed (week 16) to provide a third hair sample and complete a Fish Feedback Questionnaire. In the 8 wks following conclusion of the study they will be free to return to their normal diet.
- Conditions
- Polyunsaturated Fatty Acid (PUFA) Status
- Being tested
- Fish, Control
- Keywords
- Polyunsaturated fatty acids (PUFA), fish, fish consumption, women, childbearing age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FishDietary supplement
Lunch containing fish
ControlOther
Lunch containing no fish
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | No fish Receives: Other: Control |
| 1 portion of fish per week | Experimental | 140g fish/week Receives: Dietary Supplement: Fish |
| 2 portions of fish per week | Experimental | 280g fish/week Receives: Dietary Supplement: Fish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyunsaturated fatty acid (PUFA) status
Serum Polyunsaturated fatty acid (PUFA) status
Measured: Change at 8 weeks from baseline
Secondary outcomes (9)
Hair mercury
Hair mercury status
Measured: Change at 8 & 16 weeks from baseline
Lipid profile
Serum lipid profile
Measured: Change at 8 weeks from baseline
Iodine
Urine iodine
Measured: Change at 8 weeks from baseline
Inflammatory status
Cytokine concentration (Interleukin (IL)-5, IL-1β, IL-2, IL-4, IL-6, IL-10, MCP-1, TARC, sFlt-1, VEgF-D, CRP, TNF-α, IFN-γ)
Measured: Change at 8 weeks from baseline
Oxidative stress
Change in glutathione peroxidase and 8-isoprostanes
Measured: Change at 8 weeks from baseline
Microbiota
Faecal microbiota profile
Measured: Change at 8 weeks from baseline
Thyroid hormones
Serum T3, T4 and thyroid-stimulating hormone (TSH). Dried blood spot for thyroglobulin, T4 and TSH
Measured: Change at 8 weeks from baseline
Stable isotopes
Hair methyl-mercury and sulphur-34
Measured: Change at 8 & 16 weeks from baseline
Methyl-mercury (MeHg)
Whole blood and urine MeHg
Measured: 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 posted5 Dec 2018
- Study start1 Sep 2016
- Primary completion31 May 2017
- Study completion31 May 2017
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 Polyunsaturated Fatty Acid (PUFA) StatusStudies 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
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester, Lund University, Ministry of Health, Republic of Seychelles
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765580
- Sponsor's protocol ID
- REC/16/0077
- Acronym
- iFish
- Status last verified
- Dec 2018
- First submitted
- 4 Dec 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Conway MC, McSorley EM, Mulhern MS, Spence T, Wijngaarden EV, Watson GE, Wahlberg K, Pineda D, Broberg K, Hyland BW, Cobice DF, Strain JJ, Yeates AJ. The influence of fish consumption on serum n-3 polyunsaturated fatty acid (PUFA) concentrations in women of childbearing age: a randomised controlled trial (the iFish Study). Eur J Nutr. 2021 Apr;60(3):1415-1427. doi: 10.1007/s00394-020-02326-w. Epub 2020 Jul 28.
PubMed 32725293
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Fish Consumption on Polyunsaturated Fatty Acid (PUFA) Status (iFish Study)
- ClinicalTrials.gov ID
- NCT03765580
- Acronym / sponsor ID
- iFish / REC/16/0077
- Conditions
- Polyunsaturated Fatty Acid (PUFA) Status
- Keywords
- Polyunsaturated fatty acids (PUFA), fish, fish consumption, women, childbearing age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- University of Rochester, Lund University, Ministry of Health, Republic of Seychelles
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 5 Dec 2018 (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.
Polyunsaturated fatty acids (PUFA) are important for health, for example for the immune system, heart health and the brain. PUFA are found in fish, nuts and oils; including these foods in the diet provides the body with PUFA. The body can also produce some PUFA in a series of steps. It has been found that genetics influences the levels of PUFA produced in the body. This study will investigate whether fish consumption influences PUFA status in women of childbearing age when accounting for FADS genotype by conducting a controlled human intervention study. Participants will be asked to consume none, one or two portions of oily fish per week for 8 weeks and their response in PUFA status measured. This study will also use collected blood, hair, urine and faecal samples collected from the intervention study to explore other biomarkers of fish consumption. The aim of this study is to investigate whether fish consumption influences PUFA status in women of childbearing age when accounting for FADS genotype and to explore the potential of a novel biomarker, using hair MeHg:δ34S values, to accurately predict fish consumption. The study will initially involve providing a buccal swab sample which will investigate genes which are related to fatty acids. The participant will provide a buccal swab sample so that their genotype can be determined. The researcher who will contact the participant once genotype has been determined to arrange a baseline appointment. Participants will attend the Human Intervention Studies Unit at Ulster University, Coleraine once or twice weekly for a period of 8 weeks where they will receive lunch. This lunch will contain either tuna, sardines, or no fish depending on the intervention group you will be allocated to. Examples of lunch time meals they may receive include sandwiches, baked potato or salad which will include the type of fish they have been allocated to receive. Those allocated to the no fish group will receive a fish free alternative lunch. Participants will be asked to continue to follow their normal diet and lifestyle over the intervention period of 8 weeks. All participants will attend a baseline and post intervention appointment where they will have weight, height and body composition measured. Participants will also complete questionnaires to provide medical, lifestyle and dietary information. All participants will be asked to provide a sample of blood, urine, hair and faeces to assess biomarkers of fish consumption at baseline and post intervention appointments. Collected blood, urine, hair and faecal samples will be analysed for biomarkers of fish consumption. Participants will also be asked to return to the Human Intervention Studies Unit (HISU) 8 weeks after the intervention study has been completed (week 16) to provide a third hair sample and complete a Fish Feedback Questionnaire. In the 8 wks following conclusion of the study they will be free to return to their normal diet.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: ControlNo fish |
| 1 portion of fish per week | Experimental | Dietary Supplement: Fish140g fish/week |
| 2 portions of fish per week | Experimental | Dietary Supplement: Fish280g fish/week |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy females - premenopausal, child-bearing age, not planning to become pregnant
- Age 18-45years old
- Low consumers of fish (<2 portions/ week) or those willing to reduce their fish consumption one month prior to commencing the study to the equivalent of 2 portions per month or less
- Willing to eat 1 or 2 portions (140 grams or 280 grams) of either tuna or sardines per week for a period of 8 weeks
- Not consuming fish oil supplements
Key exclusion criteria (5 listed)
- Regularly eat fish or not willing to do washout period where they reduce fish consumption
- Are allergic to seafood
- Are taking fish oil supplements or are taking protein supplements
- Are pregnant or menopausal
- Have very short hair (a small section of hair, approximately 200 strands, will be taken at the nap of the neck for analysis purposes)
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 |
|---|---|---|
| FishLunch containing fish | Dietary supplement | 1 portion of fish per week, 2 portions of fish per week |
| ControlLunch containing no fish | Other | Control group |
Primary outcome
Polyunsaturated fatty acid (PUFA) status
Time frame: Change at 8 weeks from baseline
Serum Polyunsaturated fatty acid (PUFA) status
9 secondary outcomes
Hair mercury
Time frame: Change at 8 & 16 weeks from baseline
Lipid profile
Time frame: Change at 8 weeks from baseline
Iodine
Time frame: Change at 8 weeks from baseline
Inflammatory status
Time frame: Change at 8 weeks from baseline
Oxidative stress
Time frame: Change at 8 weeks from baseline
Microbiota
Time frame: Change at 8 weeks from baseline
Thyroid hormones
Time frame: Change at 8 weeks from baseline
Stable isotopes
Time frame: Change at 8 & 16 weeks from baseline
Methyl-mercury (MeHg)
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 5 Dec 2018.
- Derived from this study: PubMed 32725293Conway MC, McSorley EM, Mulhern MS, Spence T, Wijngaarden EV, Watson GE, Wahlberg K, Pineda D, Broberg K, Hyland BW, Cobice DF, Strain JJ, Yeates AJ. The influence of fish consumption on serum n-3 polyunsaturated fatty acid (PUFA) concentrations in women of childbearing age: a randomised controlled trial (the iFish Study). Eur J Nutr. 2021 Apr;60(3):1415-1427. doi: 10.1007/s00394-020-02326-w. Epub 2020 Jul 28.
- Individual participant dataSharing planned: Undecided
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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 Fish in people with Polyunsaturated Fatty Acid (PUFA) Status, 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 7 inclusion and 5 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 5 Dec 2018. 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?
Polyunsaturated fatty acid (PUFA) status (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 NCT03765580, 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 5 Dec 2018.