Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02840630
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE July 21, 2016
Last Update Posted Date July 12, 2019
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
Change in Glycated Hemoglobin (HbA1c) [ Time Frame: week 0 and 16 ]
HbA1c will be analysed from DBS samples at week 0 and 16.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
  • Change in Omega 3 Index [ Time Frame: week 0, 16 ]
    Omega 3 Index will be analysed from DBS samples at week 0, and 16.
  • Change in Triglycerides [ Time Frame: week 0, and 16 ]
    Triglycerides will be analysed from DBS samples at week 0 and 16.
  • Change in Vitamin D [ Time Frame: week 0, 16 ]
    Vitamin D will be analysed from DBS samples at week 0 and 16.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of FISH Intake on MEtabolic Health in a Diabetic South Asian popuLation (FISH MEAL)
Official Title  ICMJE Effect of FISH Intake on MEtabolic Health in a Diabetic South Asian popuLation (FISH MEAL)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE Other: Tinned mackerel fish
Diabetic fish intervention group will be given two tinned mackerels per week from week 0 until week 16.
Other Name: Tesco tinned mackerel fish
Study Arms  ICMJE
  • No Intervention: Non-diabetic group
    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.
  • No Intervention: Diabetic control intervention group
    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.
  • Active Comparator: Diabetic fish intervention group
    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: Other: Tinned mackerel fish
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2016)
330
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Baukje De Roos, BSc, PhD 44 (0)1224 438636 b.deroos@abdn.ac.uk
Contact: Nigel Hoggard, BSc, PhD 44 (0)1224 438655 n.hoggard@abdn.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02840630
Other Study ID Numbers  ICMJE RT10087-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Aberdeen
Study Sponsor  ICMJE University of Aberdeen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Baukje De Roos, BSc, PhD University of Aberdeen
PRS Account University of Aberdeen
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP