Skip to main content
OpenTrials
Completed

NCT Number: NCT03765580

The Influence of Fish Consumption on Polyunsaturated Fatty Acid (PUFA) Status

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Human Intervention Studies Unit, Ulster University

Coleraine, Co.Londonderry, BT52 1SA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Fish

Dietary Supplement

Lunch containing fish

Control

Other

Lunch containing no fish

Primary outcomes

  1. Polyunsaturated fatty acid (PUFA) status

    Time frame: Change at 8 weeks from baseline

    Serum Polyunsaturated fatty acid (PUFA) status

Secondary outcomes

  1. Hair mercury

    Time frame: Change at 8 & 16 weeks from baseline

    Hair mercury status

  2. Lipid profile

    Time frame: Change at 8 weeks from baseline

    Serum lipid profile

  3. Iodine

    Time frame: Change at 8 weeks from baseline

    Urine iodine

  4. Inflammatory status

    Time frame: Change at 8 weeks from baseline

    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)

  5. Oxidative stress

    Time frame: Change at 8 weeks from baseline

    Change in glutathione peroxidase and 8-isoprostanes

  6. Microbiota

    Time frame: Change at 8 weeks from baseline

    Faecal microbiota profile

  7. Thyroid hormones

    Time frame: Change at 8 weeks from baseline

    Serum T3, T4 and thyroid-stimulating hormone (TSH). Dried blood spot for thyroglobulin, T4 and TSH

  8. Stable isotopes

    Time frame: Change at 8 & 16 weeks from baseline

    Hair methyl-mercury and sulphur-34

  9. Methyl-mercury (MeHg)

    Time frame: Change at 8 weeks from baseline

    Whole blood and urine MeHg

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • Lund University
  • Ministry of Health, Republic of Seychelles
  • University of Rochester

Registry information

Official study title

The Influence of Fish Consumption on Polyunsaturated Fatty Acid (PUFA) Status (iFish Study)

Acronym: iFish

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2018
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.