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Effect of FISH Intake on MEtabolic Health in a Diabetic South Asian popuLation (FISH MEAL) (FISHMEAL)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Tinned mackerel fish
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring n3 LC-PUFA, Type 2 Diabetes Mellitus, South Asian, HbA1c, Omega 3 status

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Non-diabetic group:

Inclusion Criteria

  • 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.

Exclusion criteria

  • 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;
  • 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:

Inclusion Criteria

  • 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;
  • Diagnosed with diabetes only controlled by diet and lifestyle;
  • Ability to speak, read and understand the English language.

Exclusion criteria

  • 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.

Sites / Locations

  • University of Aberdeen Rowett Institute of Nutrition and Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Active Comparator

Arm Label

Non-diabetic group

Diabetic control intervention group

Diabetic fish intervention group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Glycated Hemoglobin (HbA1c)
HbA1c will be analysed from DBS samples at week 0 and 16.

Secondary Outcome Measures

Change in Omega 3 Index
Omega 3 Index will be analysed from DBS samples at week 0, and 16.
Change in Triglycerides
Triglycerides will be analysed from DBS samples at week 0 and 16.
Change in Vitamin D
Vitamin D will be analysed from DBS samples at week 0 and 16.

Full Information

First Posted
June 14, 2016
Last Updated
August 17, 2022
Sponsor
University of Aberdeen
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1. Study Identification

Unique Protocol Identification Number
NCT02840630
Brief Title
Effect of FISH Intake on MEtabolic Health in a Diabetic South Asian popuLation (FISH MEAL)
Acronym
FISHMEAL
Official Title
Effect of FISH Intake on MEtabolic Health in a Diabetic South Asian popuLation (FISH MEAL)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2016 (undefined)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
n3 LC-PUFA, Type 2 Diabetes Mellitus, South Asian, HbA1c, Omega 3 status

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-diabetic group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Diabetic control intervention group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Diabetic fish intervention group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tinned mackerel fish
Other Intervention Name(s)
Tesco tinned mackerel fish
Intervention Description
Diabetic fish intervention group will be given two tinned mackerels per week from week 0 until week 16.
Primary Outcome Measure Information:
Title
Change in Glycated Hemoglobin (HbA1c)
Description
HbA1c will be analysed from DBS samples at week 0 and 16.
Time Frame
week 0 and 16
Secondary Outcome Measure Information:
Title
Change in Omega 3 Index
Description
Omega 3 Index will be analysed from DBS samples at week 0, and 16.
Time Frame
week 0, 16
Title
Change in Triglycerides
Description
Triglycerides will be analysed from DBS samples at week 0 and 16.
Time Frame
week 0, and 16
Title
Change in Vitamin D
Description
Vitamin D will be analysed from DBS samples at week 0 and 16.
Time Frame
week 0, 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Non-diabetic group: Inclusion Criteria 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. Exclusion criteria 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; 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: Inclusion Criteria 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; Diagnosed with diabetes only controlled by diet and lifestyle; Ability to speak, read and understand the English language. Exclusion criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baukje De Roos, BSc, PhD
Organizational Affiliation
University of Aberdeen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Aberdeen Rowett Institute of Nutrition and Health
City
Aberdeen
ZIP/Postal Code
AB21 9SB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of FISH Intake on MEtabolic Health in a Diabetic South Asian popuLation (FISH MEAL)

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