Chronic omega-3 fatty acid supplementation in type 1 diabetes

ISRCTN ISRCTN40811115
DOI https://doi.org/10.1186/ISRCTN40811115
IRAS number 223639
Secondary identifying numbers IRAS 223639
Submission date
13/06/2017
Registration date
27/06/2017
Last edited
19/07/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Diabetes is a chronic condition that causes blood sugar (glucose) levels to be uncontrolled. People with Type 1 Diabetes (T1D) have an increased risk of cardiovascular disease (CVD) (heart problems) which significantly reduces life expectancy and quality of life. Metabolic (chemical processes that convert food to energy) and vascular (heart and blood vessels) abnormalities which are typically present in T1D contribute heavily to this risk and can be impacted by diet. Foods that are normally consumed in the westernized world are predominantly high in carbohydrate (sugars, starches and fibres in food) and fat, which, in the presence of T1D, can cause a higher CVD risk. It has been found that a dietary supplement Omega-3 Fatty Acids (n3-FA) can reduce many CVD biomarkers in people with CVD and Type 2 Diabetes, but owing to a lack of available information, it is unknown whether such improvements can help people with T1D. The aim of this study is to examine the glycaemic (sugar), lipaemic (fat), inflammatory (swelling), and vascular (blood vessel) response of patients with T1D after consuming meals with high carbohydrates and fat following six months of n3-FA dietary supplement.

Who can participate?
Adults aged 18 to 65 years old with T1D

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive a supplement containing fish oil that is taken by mouth daily for six months, followed by a 13 week washout period (where they do not take anything). During this time, participants attend the study centre four times, once before taking the supplement and again at three, six and nine months. They consume meals with high carbohydrates and high-fat content and provide blood samples and undergo non-invasive vascular heart) scans. Participants in the second group receive a placebo tablet containing corn oil taken by mouth daily for six weeks, followed by a 13 week washout period (where they do not take anything). During this time, participants attend the study centre four times, once before taking the supplement and again at three, six and nine months. They consume meals with high carbohydrates and high-fat content and provide blood samples and undergo non-invasive vascular heart) scans. Participants are assessed for their blood fat, glucose (sugar) levels and their vascular responses to see how the supplements affect their diabetes.

What are the possible benefits and risks of participating?
Participants may benefit from improving their management of their diabetes by receiving more refined recommendations for long-term and meal-time self-management. There are no notable risks with participating, however, participants may experience discomfort while providing blood samples.

Where is the study run from?
Leeds Beckett University (UK)

When is the study starting and how long is it expected to run for?
January 2017 to September 2019

Who is funding the study?
1. Leeds Beckett University (UK)
2. Nutricia Research Foundation (Netherlands)

Who is the main contact?
Dr Matthew Campbell

Contact information

Dr Matthew Campbell
Scientific

Fairfax Hall Room 113
Headingly Campus
Leeds Beckett University
Leeds
LS6 3QT
United Kingdom

ORCiD logoORCID ID 0000-0001-5883-5041

Study information

Study designInterventional randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet ISRCTN40811115_PIS_13Jun17_V1.docx
Scientific titleThe therapeutic role of chronic omega-3 fatty acid supplementation in type 1 diabetes patients
Study objectives1. Chronic supplementation with omega-3 fatty acids will lower the acute glycaemic and lipaemic disturbances associated with high-fat meal feeding.
2. Chronic supplementation with omega-3 fatty acids will lower the acute inflammatory and vascualr disturbances associated with high-fat meal feeding.
3. Chronic supplementation with omega-3 fatty acids will lower long-term markers of glycaemia, lipaemia, and inflammation disturbances following three-months washout.
4. Patient's attitudes towards n3-FA supplementation (compliance, adherence, facilitators, barriers, quality of life) will be positive.
Ethics approval(s)Approved 10/08/2017, North East - Tyne & Wear South Research Ethics Committee (HRA Jarrow, Room 001, Jarrow Business Centre, Rolling Mill Road, Jarrow, NE32 3DT, UK; +44 (0)207 1048 084; tyneandwearsouth.rec@hra.nhs.uk); REC ref: 17/NE/0244
Health condition(s) or problem(s) studiedType 1 Diabetes
InterventionParticipants are randomized (using a commuter automated programme) to one of two treatment groups (n3-FA supplementation or placebo control).

Arm 1 Supplementation: Participants receive the n3-FA supplement that comprises of ~4.0g.day of fish oil concentrate delivered via capsule ingestion (1.9g of EPA and 1.5g of DHA). This will be taken for a total of 26 weeks ( six months) and is followed by a 13-week "washout" period. During this time, participants attend the laboratory on four occasions (a baseline visit, three months, six months, and nine months). Laboratory visits involve consuming mixed-macro-nutrient meals with high carbohydrate and high fat contents. During each visit blood samples are measured over an eight hour period to determine glycaemic, lipaemic, and inflammatory parameters, accompanied by periodic non-invasive vascular scanning techniques to assess vascular function.

Arm 2 Placebo Control: Participants receive the placebo which is a corn oil capsule for 26 weeks (six months) followed by a 13-week "washout" period. During this time, participants attend the laboratory on four occasions (a baseline visit, three months, six months, and nine months). Laboratory visits involve consuming mixed-macro-nutrient meals with high carbohydrate and high fat contents. During each visit blood samples are measured over an eight hour period to determine glycaemic, lipaemic, and inflammatory parameters, accompanied by periodic non-invasive vascular scanning techniques to assess vascular function.
Intervention typeSupplement
Primary outcome measure1. Blood glucose is measured using the Biosen C-Line at 30 minutes intervals throughout an 8-hour observation window at baseline, three, six and nine months
2. Blood lipid/fat is measured using the biochemical analysis (Elisa/Essay technique) at 30 minutes intervals throughout an 8-hour observation window at baseline, three, six and nine months
Secondary outcome measures1. Inflammatory responses to mixed meals that are high in carbohydrate and fat, following n3-FA supplementation is measured using biochemical analysis (Elisa/Essay technique) at 30-minutes intervals throughout an 8-hour observation window at baseline, three, six and nine months
2. Vascular responses to mixed meals that are high in carbohydrate and fat, following n3-FA supplementation is measured using vascular imagining techniques at baseline, between 3-4 hours post-breakfast, and between 7-8 hours post-breakfast at baseline, three, six and nine months
3. Long-term resting glycaemic, lipaemic, inflammatory, and vascular responses to chronic n3-FA supplementation are measured using biochemical analysis (Elisa/Essay technique) at baseline, 3-months, and 6-months post intervention
4. Glycaemic, lipaemic, inflammatory, and vascular responses to chronic n3-FA supplementation following 3-months washout are measured using biochemical analysis (Elisa/Essay technique) and vascular scanning techniques at 9-months post intervention
5. Compliance and adherence towards n3-FA supplementation is measured using EHA and DHA from plasma/serum at baseline, 3-months, 6-months, and 9-months
7. Facilitators to n3-FA supplementation is measured using a non-validated questionnaire at baseline
8. Barriers to n3-FA supplementation is measured using a non-validated questionnaire at baseline
9. Quality of life is measured using a non-validated questionnaire at baseline, 3-months, 6-months, and 9-months post-intervention
Overall study start date07/01/2017
Completion date01/09/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants32
Total final enrolment20
Key inclusion criteriaCurrent inclusion criteria as of 01/04/2020:
1. Male or female and aged 18-65 years old
2. Free from any diabetes-related complications (except background diabetic retinopathy)
3. Not known to be allergic or sensitive to fish, fish oil, or n3-FA products
4. Not known to have or have had documented atrial fibrillation
5. Not known to have documented liver problems or abnormal liver function
6. Will not be pregnant, planning to become pregnant within 12 months, or currently breastfeeding
7. Not known to have documented hematological abnormalities or experience heavy menstrual bleeding
8. Not taking prescribed medication knowing to interfere with study procedures
9. Treated with a stable insulin regimen composed of either:
9.1. A combination of slow/long-acting insulin glargine/detemir and a fast-acting insulin analogue lispro/aspart/glulisine
9.2. Continuous subcutaneous insulin infusion therapy (insulin pump therapy)
10. Have an HbA1c of <11% (97 mmol/mol)
11. Using the carbohydrate counting method for administering meal-time insulin

Previous inclusion criteria:
1. Male or female and aged 18-65 years old
2. Free from any diabetes-related complications (except background diabetic retinopathy)
3. Not known to be allergic or sensitive to fish, fish oil, or n3-FA products
4. Not known to have or have had documented atrial fibrillation
5. Not known to have documented liver problems or abnormal liver function
6. Will not be pregnant, planning to become pregnant within 12 months, or currently breastfeeding
7. Not known to have documented hematological abnormalities or experience heavy menstrual bleeding
8. Not taking any prescribed medication other than insulin
9. Treated with a stable insulin regimen composed of either:
9.1. A combination of slow/long-acting insulin glargine/detemir and a fast-acting insulin analogue lispro/aspart/glulisine
9.2. Continuous subcutaneous insulin infusion therapy (insulin pump therapy)
10. Have an HbA1c of <11% (97 mmol/mol)
11. Using the carbohydrate counting method for administering meal-time insulin
Key exclusion criteriaNone.
Date of first enrolment01/09/2017
Date of final enrolment01/01/2019

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Leeds Beckett University
School of Sport
Headingley Campus
Leeds
LS6 3QT
United Kingdom

Sponsor information

Leeds Beckett University
University/education

Fairfax Hall
Headingley Campus
Leeds
LS6 3QT
England
United Kingdom

Website http://www.leedsbeckett.ac.uk/
ROR logo "ROR" https://ror.org/02xsh5r57

Funders

Funder type

University/education

Leeds Beckett University
Private sector organisation / Universities (academic only)
Alternative name(s)
Leeds Beckett
Location
United Kingdom
Nutricia Research Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Location
Netherlands

Results and Publications

Intention to publish date01/09/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal, and as conference proceedings.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr Matthew Campbell (m.d.campbell@leeds.ac.uk) (PI); raw anonymised data; available after publication for a total of 5 years; publicly available, for secondary data analysis or re-analysis including meta-analysis.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version V1 13/06/2017 01/04/2019 No Yes
Results article results 12/08/2020 17/08/2020 Yes No
HRA research summary 28/06/2023 No No
Results article 03/06/2022 19/07/2024 Yes No

Additional files

ISRCTN40811115_PIS_13Jun17_V1.docx
Uploaded 01/04/2019

Editorial Notes

19/07/2024: Publication reference added.
17/08/2020: Publication reference and total final enrolment number added.
03/04/2020: The ethics approval and IPD sharing statement were updated.
01/04/2020: The inclusion criteria were updated.
01/04/2019: The participant information sheet has been uploaded
27/04/2018: The recruitment end date has been changed from 01/09/2017 to 01/01/2019.