Evidence map›Paper›PMID 32787879›Full record

Trial reportCardiovascular diabetology2020

Omega-3 polyunsaturated fatty acid supplementation versus placebo on vascular health, glycaemic control, and metabolic parameters in people with type 1 diabetes: a randomised controlled preliminary trial.

Lauren L O'Mahoney, Gareth Dunseath, Rachel Churm, Mel Holmes, Christine Boesch, Antonios Stavropoulos-Kalinoglou, Ramzi A Ajjan, Karen M Birch, Nicolas M Orsi, Georgia Mappa and 2 more

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cardiovascular diabetology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
3.6field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 1 country.

Lauren L O'MahoneyCarnegie School of Sport, Leeds Beckett University, Leeds, UK.
Gareth DunseathDiabetes Research Group, Swansea University Medical School, Swansea University, Swansea, UK.
Rachel ChurmApplied Sports, Technology, Exercise and Medicine (A-STEM) Research Centre, Swansea University, Swansea, UK.
Mel HolmesSchool of Food Science and Nutrition, Faculty of Environment, University of Leeds, Leeds, LS2 9JT, UK.
Christine BoeschSchool of Food Science and Nutrition, Faculty of Environment, University of Leeds, Leeds, LS2 9JT, UK.
Antonios Stavropoulos-KalinoglouCarnegie School of Sport, Leeds Beckett University, Leeds, UK.
Ramzi A AjjanLeeds Institute of Cardiovascular and Metabolic Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, UK.
Karen M BirchSchool of Biomedical Sciences, University of Leeds, Leeds, UK.
Nicolas M OrsiLeeds Institute of Medical Research at St James's, St James's University Hospital, Leeds, UK.
Georgia MappaLeeds Institute of Medical Research at St James's, St James's University Hospital, Leeds, UK.
Oliver J PriceCarnegie School of Sport, Leeds Beckett University, Leeds, UK.
Matthew D CampbellSchool of Food Science and Nutrition, Faculty of Environment, University of Leeds, Leeds, LS2 9JT, UK. m.d.campbell@leeds.ac.uk.ORCID 0000-0001-5883-5041
University of Leeds · GBLeeds Beckett University · GBSt James's University Hospital · GBSwansea University · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe role of omega-3 polyunsaturated fatty acids (n-3PUFA), and the potential impact of n-3PUFA supplementation, in the treatment and management of type 1 diabetes (T1D) remains unclear and controversial. Therefore, this study aimed to examine the efficacy of daily high-dose-bolus n-3PUFA supplementation on vascular health, glycaemic control, and metabolic parameters in subjects with T1D.

methodsTwenty-seven adults with T1D were recruited to a 6-month randomised, double-blind, placebo-controlled trial. Subjects received either 3.3 g/day of encapsulated n-3PUFA or encapsulated 3.0 g/day corn oil placebo (PLA) for 6-months, with follow-up at 9-months after 3-month washout. Erythrocyte fatty acid composition was determined via gas chromatography. Endpoints included inflammation-associated endothelial biomarkers (vascular cell adhesion molecule-1 [VCAM-1], intercellular adhesion molecule-1 [ICAM-1], E-selectin, P-selectin, pentraxin-3, vascular endothelial growth factor [VEGF]), and their mediator tumor necrosis factor alpha [TNFα] analysed via immunoassay, vascular structure (carotid intima-media thickness [CIMT]) and function (brachial artery flow mediated dilation [FMD]) determined via ultrasound technique, blood pressure, glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), and postprandial metabolism.

resultsTwenty subjects completed the trial in full. In the n-3PUFA group, the mean ± SD baseline n-3PUFA index of 4.93 ± 0.94% increased to 7.67 ± 1.86% (P < 0.001) after 3-months, and 8.29 ± 1.45% (P < 0.001) after 6-months. Total exposure to n-3PUFA over the 6-months (area under the curve) was 14.27 ± 3.05% per month under n-3PUFA, and 9.11 ± 2.74% per month under PLA (P < 0.001). VCAM-1, ICAM-1, E-selectin, P-selectin, pentraxin-3, VEGF, TNFα, CIMT, FMD, blood pressure, HbA1c, FPG, and postprandial metabolism did not differ between or within groups after treatment (P > 0.05).

conclusionsThis study indicates that daily high-dose-bolus of n-3PUFA supplementation for 6-months does not improve vascular health, glucose homeostasis, or metabolic parameters in subjects with T1D. The findings from this preliminary RCT do not support the use of therapeutic n-3PUFA supplementation in the treatment and management of T1D and its associated complications. Trial Registration ISRCTN, ISRCTN40811115. Registered 27 June 2017, http://www.isrctn.com/ISRCTN40811115 .

Indexed as

Dietary SupplementsGlycemic ControlAdultBiomarkersBlood GlucoseBlood PressureDiabetes Mellitus, Type 1Double-Blind MethodEnglandFatty Acids, Omega-3FemaleGlycated HemoglobinHemodynamicsHumansHypoglycemic AgentsInflammation MediatorsBiomarkersBlood GlucoseFatty Acids, Omega-3Glycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInflammation MediatorsGlycaemic controlOmega-3 polyunsaturated fatty acidsType 1 diabetesVascular health

Identifiers

PMID32787879
PMCPMC7425064
OpenAlexW3048930036

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.