Chronic omega-3 fatty acid supplementation in type 1 diabetes
ISRCTN | ISRCTN40811115 |
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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
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
Scientific
Fairfax Hall Room 113
Headingly Campus
Leeds Beckett University
Leeds
LS6 3QT
United Kingdom
0000-0001-5883-5041 |
Study information
Study design | Interventional randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Treatment |
Participant information sheet | ISRCTN40811115_PIS_13Jun17_V1.docx |
Scientific title | The therapeutic role of chronic omega-3 fatty acid supplementation in type 1 diabetes patients |
Study objectives | 1. 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) studied | Type 1 Diabetes |
Intervention | Participants 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 type | Supplement |
Primary outcome measure | 1. 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 measures | 1. 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 date | 07/01/2017 |
Completion date | 01/09/2019 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 65 Years |
Sex | Both |
Target number of participants | 32 |
Total final enrolment | 20 |
Key inclusion criteria | Current 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 criteria | None. |
Date of first enrolment | 01/09/2017 |
Date of final enrolment | 01/01/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Headingley Campus
Leeds
LS6 3QT
United Kingdom
Sponsor information
University/education
Fairfax Hall
Headingley Campus
Leeds
LS6 3QT
England
United Kingdom
Website | http://www.leedsbeckett.ac.uk/ |
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https://ror.org/02xsh5r57 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Leeds Beckett
- Location
- United Kingdom
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- Netherlands
Results and Publications
Intention to publish date | 01/09/2020 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal, and as conference proceedings. |
IPD sharing plan | The 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? |
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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.