Diabetes Mellitus, Type 2FISHMEALNCT02840630
Effect of FISH Intake on MEtabolic Health in a Diabetic South Asian popuLation (FISH MEAL)
A study testing Tinned mackerel fish in people with Diabetes Mellitus, Type 2, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
The investigators will recruit non-diabetic volunteers (n=30) and diabetic volunteers controlled by diet and lifestyle (n=300). The non-diabetic volunteers will be in the non-diabetic group while the diabetic volunteers will be randomised to a diabetic control intervention group or a diabetic fish intervention group. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Tinned mackerel fish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2016to 8 Jan 2019
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Of South Asian origin (defined by country of birth, last name and self-report ethnicity)
- Men and women between the age of 25 and 65;
- Body mass index (BMI) of ≥23 kg/m2 according to WHO classification for Asian population;
- Ability to speak, read and understand the English language.
- Of South Asian origin (defined by country of birth, last name and self-report ethnicity)
- Men and women between the age of 25 and 65;
Show all 9Show fewer
- Body mass index (BMI) of ≥23 kg/m2 according to WHO classification for Asian population;
- Diagnosed with diabetes only controlled by diet and lifestyle;
- Ability to speak, read and understand the English language.
Who cannot join
- Use of tobacco;
- Use of insulin or oral hypoglycaemic agents;
- Use of medications that are known to affect lipid metabolism,
- Haemophiliacs,
- Use of medications that are known to generally alter the haemostatic system;
- Diagnosis of diabetes;
Show all 18Show fewer
- Diagnosis of hypertension, renal, hepatic, haematological disease or coronary heart disease;
- Have previously donated blood for transfusion purposes within the last month;
- Inability to understand participant information sheet.
- Diabetic control intervention and diabetic fish intervention group:
- Use of tobacco;
- Use of insulin or oral hypoglycemic agents;
- Use of medications that are known to affect lipid metabolism;
- Haemophiliacs;
- Use of medications that are known to generally alter the hemostatic system;
- Diagnosis of hypertension, renal, hepatic, haematological disease or coronary heart disease;
- Have previously donated blood for transfusion purposes within the last month;
- Inability to understand participant information sheet.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Aberdeen Rowett Institute of Nutrition and Health
Aberdeen, AB21 9SB
About this study
The investigators will recruit non-diabetic volunteers (n=30) and diabetic volunteers controlled by diet and lifestyle (n=300). The non-diabetic volunteers will be in the non-diabetic group while the diabetic volunteers will be randomised to a diabetic control intervention group or a diabetic fish intervention group. Baseline data will be collected from all three groups but only diabetic control intervention group and diabetic fish intervention group will go through the 16-week study. This will allow the investigators to compare the metabolic health across South Asian population in people with and without diabetes.
The recommended intake of EPA and DHA daily is ~450 mg per day for cardiovascular health, or approximately 3 g per week. Over the course of 16 weeks, subjects in the diabetic control intervention group will continue with their habitual diet, while subjects in the diabetic fish intervention group will receive two 125 g portion of tinned mackerel (containing 7.8 g n-3 LCPUFA26) every week, to replace a portion of red meat or poultry. Previous n-3 LCPUFA intervention study among South Asian people in the United Kingdom was able to reverse lipid abnormalities with supplementation of 2.5 g of EPA and DHA per day for 12 weeks. However, the same study also shows that their daily consumption of EPA and DHA is only 68±99 and 112±171 mg respectively. Therefore, only 1.1 g n-3 LCPUFA per day is given in this study to increase compliance.
Read more
Recipe recommendations using mackerel will be provided. Non-diabetic volunteers will be recruited only to obtain baseline data in order to compare their metabolic profile with that of the diabetic volunteers. This will allow us to investigate the link between omega 3 status and glycaemic control in a South Asian population.
Fish is chosen as an intervention as opposed to EPA and DHA supplements in order to capture the benefits of eating fish as an important source of not only n-3 LCPUFA, but also other key nutrients such as vitamin D, selenium and iodine.
Read the detailed description
During the study period, participants will be asked to maintain their routine dietary and social habits to avoid changes in body weight. In addition volunteers will be asked to record their weights first thing in the morning on the same set of scales every week. Any changes can be documented in a food frequency questionnaire. Volunteers without diabetes will be recruited for baseline data and will not be involved in the 16-week intervention study. Diabetic volunteers will be randomized by BioSS in batches of ~20 people into the diabetic control or the diabetic fish intervention group that will be matched for gender, age and BMI. The diabetic control group will be asked to continue with their routine dietary habits while the diabetic fish intervention group will be asked to substitute poultry or red meat with 2 tins of mackerels each week. Study kits will be posted two weeks before the study initiates to consenting volunteers.
All volunteers will be asked to provide finger prick blood spots on filter paper at week 0, while subjects allocated to diabetic control and diabetic fish intervention groups will be asked to provide blood spots again at week 8 and 16. A dried blood spot (DBS) sampling kit containing two Whatman 903 filter papers, two lancets, alcohol pads, bandaids, guidelines on spotting blood on filter paper, prepaid envelope, FFQ, tinned mackerel and a fish recipe book. Every volunteer will be asked to prick the inside tip of a non-dominant finger and gently spot a total of ten circles in the filter papers. A volunteer might experience slight discomfort when the lancet goes into the finger. The volunteers will then allow the filter paper to dry for about an hour before closing the flap over the filter paper. All information and tools to help with obtaining the dried blood spots, as well as guidelines on how to spot blood on filter paper will be included with the DBS kit. Volunteers are required to spot 2 filter papers at one collection point and post them in a pre-paid envelope complete with a return address.
The DBS samples will be analyzed for omega 3 index, glycated hemoglobin (HbA1c), triglycerides, Vitamin D status, genetic (TCF7L2 7903146) and epigenetic marker (FADS 174546) of lipid and glucose control.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Tinned mackerel fish
- Keywords
- n3 LC-PUFA, Type 2 Diabetes Mellitus, South Asian, HbA1c, Omega 3 status
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinned mackerel fishOther
Also called Tesco tinned mackerel fish
Diabetic fish intervention group will be given two tinned mackerels per week from week 0 until week 16.
| Study group | Role | What they receive |
|---|---|---|
| Non-diabetic group | No intervention | Non-diabetic volunteers will be recruited for baseline data. They will only be required to provide dried blood samples (DBS) samples and information at week 0. They have to collect finger prick DBS, weigh themselves and fill in food frequency questionnaire only at one time point. |
| Diabetic control intervention group | No intervention | The diabetic control group will provide finger prick DBS at week 0, 8 and 16, fill in food frequency questionnaire at week 0 and 16 and weekly weighing from week 0 until 16. This group will not be receiving tinned mackerel and will be asked to continue with their habitual diet and lifestyle. |
| Diabetic fish intervention group | Active comparator | This intervention group will receive two 125 g portion of tinned mackerel fish (containing 7.8 g n-3 LCPUFA) per week from week 0 until 16 and a mackerel recipe book each. They will be required to provide finger prick DBS at week 0, 8 and 16, fill in food frequency questionnaire at week 0 and 16 and weekly weighing from week 0 until 16. Receives: Other: Tinned mackerel fish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Hemoglobin (HbA1c)
HbA1c will be analysed from DBS samples at week 0 and 16.
Measured: week 0 and 16
Secondary outcomes (3)
Change in Omega 3 Index
Omega 3 Index will be analysed from DBS samples at week 0, and 16.
Measured: week 0, 16
Change in Triglycerides
Triglycerides will be analysed from DBS samples at week 0 and 16.
Measured: week 0, and 16
Change in Vitamin D
Vitamin D will be analysed from DBS samples at week 0 and 16.
Measured: week 0, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start1 Oct 2016
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baukje De Roos, BSc, PhD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840630
- Sponsor's protocol ID
- RT10087-10
- Acronym
- FISHMEAL
- Status last verified
- Aug 2026
- First submitted
- 14 Jun 2016
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of FISH Intake on MEtabolic Health in a Diabetic South Asian popuLation (FISH MEAL)
- ClinicalTrials.gov ID
- NCT02840630
- Acronym / sponsor ID
- FISHMEAL / RT10087-10
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- n3 LC-PUFA, Type 2 Diabetes Mellitus, South Asian, HbA1c, Omega 3 status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 21 Jul 2016 (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.
The investigators will recruit non-diabetic volunteers (n=30) and diabetic volunteers controlled by diet and lifestyle (n=300). The non-diabetic volunteers will be in the non-diabetic group while the diabetic volunteers will be randomised to a diabetic control intervention group or a diabetic fish intervention group. Baseline data will be collected from all three groups but only diabetic control intervention group and diabetic fish intervention group will go through the 16-week study. This will allow the investigators to compare the metabolic health across South Asian population in people with and without diabetes.
The recommended intake of EPA and DHA daily is ~450 mg per day for cardiovascular health, or approximately 3 g per week. Over the course of 16 weeks, subjects in the diabetic control intervention group will continue with their habitual diet, while subjects in the diabetic fish intervention group will receive two 125 g portion of tinned mackerel (containing 7.8 g n-3 LCPUFA26) every week, to replace a portion of red meat or poultry. Previous n-3 LCPUFA intervention study among South Asian people in the United Kingdom was able to reverse lipid abnormalities with supplementation of 2.5 g of EPA and DHA per day for 12 weeks. However, the same study also shows that their daily consumption of EPA and DHA is only 68±99 and 112±171 mg respectively. Therefore, only 1.1 g n-3 LCPUFA per day is given in this study to increase compliance.
Recipe recommendations using mackerel will be provided. Non-diabetic volunteers will be recruited only to obtain baseline data in order to compare their metabolic profile with that of the diabetic volunteers. This will allow us to investigate the link between omega 3 status and glycaemic control in a South Asian population.
Fish is chosen as an intervention as opposed to EPA and DHA supplements in order to capture the benefits of eating fish as an important source of not only n-3 LCPUFA, but also other key nutrients such as vitamin D, selenium and iodine.
Detailed description
During the study period, participants will be asked to maintain their routine dietary and social habits to avoid changes in body weight. In addition volunteers will be asked to record their weights first thing in the morning on the same set of scales every week. Any changes can be documented in a food frequency questionnaire. Volunteers without diabetes will be recruited for baseline data and will not be involved in the 16-week intervention study. Diabetic volunteers will be randomized by BioSS in batches of ~20 people into the diabetic control or the diabetic fish intervention group that will be matched for gender, age and BMI. The diabetic control group will be asked to continue with their routine dietary habits while the diabetic fish intervention group will be asked to substitute poultry or red meat with 2 tins of mackerels each week. Study kits will be posted two weeks before the study initiates to consenting volunteers.
All volunteers will be asked to provide finger prick blood spots on filter paper at week 0, while subjects allocated to diabetic control and diabetic fish intervention groups will be asked to provide blood spots again at week 8 and 16. A dried blood spot (DBS) sampling kit containing two Whatman 903 filter papers, two lancets, alcohol pads, bandaids, guidelines on spotting blood on filter paper, prepaid envelope, FFQ, tinned mackerel and a fish recipe book. Every volunteer will be asked to prick the inside tip of a non-dominant finger and gently spot a total of ten circles in the filter papers. A volunteer might experience slight discomfort when the lancet goes into the finger. The volunteers will then allow the filter paper to dry for about an hour before closing the flap over the filter paper. All information and tools to help with obtaining the dried blood spots, as well as guidelines on how to spot blood on filter paper will be included with the DBS kit. Volunteers are required to spot 2 filter papers at one collection point and post them in a pre-paid envelope complete with a return address.
The DBS samples will be analyzed for omega 3 index, glycated hemoglobin (HbA1c), triglycerides, Vitamin D status, genetic (TCF7L2 7903146) and epigenetic marker (FADS 174546) of lipid and glucose control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-diabetic group | No intervention | –Non-diabetic volunteers will be recruited for baseline data. They will only be required to provide dried blood samples (DBS) samples and information at week 0. They have to collect finger prick DBS, weigh themselves and fill in food frequency questionnaire only at one time point. |
| Diabetic control intervention group | No intervention | –The diabetic control group will provide finger prick DBS at week 0, 8 and 16, fill in food frequency questionnaire at week 0 and 16 and weekly weighing from week 0 until 16. This group will not be receiving tinned mackerel and will be asked to continue with their habitual diet and lifestyle. |
| Diabetic fish intervention group | Active comparator | Other: Tinned mackerel fishThis intervention group will receive two 125 g portion of tinned mackerel fish (containing 7.8 g n-3 LCPUFA) per week from week 0 until 16 and a mackerel recipe book each. They will be required to provide finger prick DBS at week 0, 8 and 16, fill in food frequency questionnaire at week 0 and 16 and weekly weighing from week 0 until 16. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Of South Asian origin (defined by country of birth, last name and self-report ethnicity)
- Men and women between the age of 25 and 65;
- Body mass index (BMI) of ≥23 kg/m2 according to WHO classification for Asian population;
- Ability to speak, read and understand the English language.
- Of South Asian origin (defined by country of birth, last name and self-report ethnicity)
Key exclusion criteria (18 listed)
- Use of tobacco;
- Use of insulin or oral hypoglycaemic agents;
- Use of medications that are known to affect lipid metabolism,
- Haemophiliacs,
- Use of medications that are known to generally alter the haemostatic system;
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 |
|---|---|---|
| Tinned mackerel fishAlso: Tesco tinned mackerel fishDiabetic fish intervention group will be given two tinned mackerels per week from week 0 until week 16. | Other | Diabetic fish intervention group |
Primary outcome
Change in Glycated Hemoglobin (HbA1c)
Time frame: week 0 and 16
HbA1c will be analysed from DBS samples at week 0 and 16.
3 secondary outcomes
Change in Omega 3 Index
Time frame: week 0, 16
Change in Triglycerides
Time frame: week 0, and 16
Change in Vitamin D
Time frame: week 0, 16
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 31 Aug 2026.
- Individual participant dataSharing planned: No
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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, BSc, PhD principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tinned mackerel fish in people with Diabetes Mellitus, Type 2, 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?
The sponsor lists 9 inclusion and 18 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 31 Aug 2026. 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. 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 Glycated Hemoglobin (HbA1c) (time frame: week 0 and 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.