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

NCT02840630 | Unknown

• 1 other identifier: RT10087-10
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

n3 LC-PUFA; Type 2 Diabetes Mellitus; South Asian; HbA1c; Omega 3 status

Outcome Measures

Primary Outcomes (1)

• Change in Glycated Hemoglobin (HbA1c)

  HbA1c will be analysed from DBS samples at week 0 and 16.

  week 0 and 16

Secondary Outcomes (3)

• Change in Omega 3 Index

  week 0, 16

• Change in Triglycerides

  week 0, and 16

• Change in Vitamin D

  week 0, 16

Study Arms (3)

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.

Other: Tinned mackerel fish

Interventions

Tinned mackerel fish OTHER

Diabetic fish intervention group will be given two tinned mackerels per week from week 0 until week 16.

Also known as: Tesco tinned mackerel fish

Diabetic fish intervention group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

University of Aberdeen Rowett Institute of Nutrition and Health

Aberdeen, AB21 9SB, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Baukje De Roos, BSc, PhD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: July 21, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)