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

A Akbari-Sedigh; A Julibert; A Kohler; A Langsted; A Mansoori; A Siniarski; A Stirban; A Tenenbaum; AA Rivellese; AM Darwesh; Antonios Stavropoulos-Kalinoglou; AP Haines; Christine Boesch; CY Wong; D Turner; DG Altman; DJ West; DP Brostow; E Galkina; EM Lonn; EP Weiss; EY Chew; F Faul; F Shidfar; Gareth Dunseath; GE Crichton; Georgia Mappa; H Chen; J Hartweg; J Hartweg; J Skrha Jr; JM Norris; Karen M. Birch; KG McCormick; KR Kulich; L Ménégaut; Lauren L. O’Mahoney; LL O’Mahoney; M Goua; M Poreba; MA Leslie; Matthew D. Campbell; MD Campbell; Mel Holmes; Nicolas M. Orsi; O Sheikh; Oliver J. Price; P Clausen; P Sapieha; P Stiefel; Rachel Churm; Ramzi A. Ajjan; RJ Woodman; S Bansal; S Cocking; T Aung; T Hamazaki; T Jensen; T Mita; TA Mori; TA Mori; TJ Brown; TM Wang; W Khovidhunkit; X Bi; X Li

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

Abstract

Background: The 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. Methods: Twenty-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. Results: Twenty 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 0.05). Conclusions: This 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