A randomized-controlled clinical trial investigating the effect of omega-3 fatty acids and vitamin E co-supplementation on markers of insulin metabolism and lipid profiles in gestational diabetes
Authors: Mehri Jamilian
Marzieh Sanami
Mohsen Taghizadeh
Zatollah Asemi
Maryam Mazloomi
Journal: Journal of Clinical Lipidology (2016)
Discipline: PHARMACOLOGY & TOXICOLOGY
Keywords: Gestational diabetes; Omega-3 fatty acids; Pregnant women; Supplementation; Vitamin E.
Affiliations: Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran., Endocrinology and Metabolism Research Center, Arak University of Medical Sciences, Arak, Iran; Department of Gynecology and Obstetrics, School of Medicine, Arak University of Medical Sciences, Arak, Iran., Department of Gynecology and Obstetrics, School of Medicine, Iran University of Medical Sciences, Tehran, I.R. Iran., Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran. Electronic address: .

Abstract:  Background: Limited data are available that evaluated the effects of combined omega-3 fatty acids and vitamin E supplementation on glucose homeostasis parameters and lipid concentrations in gestational diabetes (GDM). Objectives: The present study was designed to determine the effects of omega-3 fatty acids and vitamin E co-supplementation on glucose homeostasis parameters and lipid concentrations among women with GDM who were not on oral hypoglycemic agents. Methods: This prospective randomized, double-blind, placebo-controlled clinical trial was carried out among 60 patients with GDM. Patients were randomly allocated to take either 1000-mg omega-3 fatty acids from flaxseed oil plus 400-IU vitamin E supplements (n = 30) or placebo (n = 30) for 6 weeks. Fasting blood samples were obtained from at the beginning of the study and after 6-week intervention to quantify related variables. Results: After 6 weeks of intervention, changes in fasting plasma glucose (-11.8 ¬± 11.0 vs +1.5 ¬± 11.9 mg/dL, P &lt; .001), serum insulin concentrations (-1.8 ¬± 6.9 vs +5.8 ¬± 12.1 ŒºIU/mL, P = .004), homeostasis model of assessment-estimated insulin resistance (-0.8 ¬± 1.6 vs +1.4 ¬± 2.8, P = .001), homeostasis model of assessment-estimated beta cell function (-0.2 ¬± 27.7 vs +22.8 ¬± 48.2, P = .02), and quantitative insulin sensitivity check index (+0.01 ¬± 0.02 vs -0.01 ¬± 0.02, P = .01) in the omega-3 fatty acids plus vitamin E group were significantly different from the changes in these indicators in the placebo group. Changes in serum triglycerides (+10.8 ¬± 41.5 vs +34.2 ¬± 35.5 mg/dL, P = .02), VLDL-cholesterol (+2.1 ¬± 8.3 vs +6.8 ¬± 7.1 mg/dL, P = .02), low-density lipoprotein (LDL)-cholesterol (+11.6 ¬± 18.8 vs +1.7 ¬± 15.9 mg/dL, P = .03) and HDL-cholesterol concentrations (+1.9 ¬± 8.7 vs -2.4 ¬± 7.7 mg/dL, P = .04) were significantly different between the supplemented women and placebo group. However, after controlling for baseline total cholesterol levels, maternal age, and BMI at baseline, the changes in serum LDL-cholesterol concentrations were not significantly different between the 2 groups. We did not find any significant effect of joint omega-3 fatty acids and vitamin E supplementation on total cholesterol concentrations. Conclusions: Overall, we demonstrated that omega-3 fatty acids and vitamin E co-supplementation in GDM women had beneficial effects on glucose homeostasis parameters, serum triglycerides, VLDL-cholesterol, and HDL-cholesterol concentrations, but it did not influence total-cholesterol and LDL-cholesterol levels. 

Retracted: No

PubPeer comments:
 There are many concerns about the integrity of 172 publications by this research group, including this one. Some of the concerns are published 1. Anaesthesia 2020;75:1683u201392, see Supplementary data. This paper is A77 2. Account Res 2020;28:149-61. 3. J Clin Epidemiol 2021;131:22-29. Journals and publishers were notified of these concerns in July 2019. 23 publications have an expression of concern. To our knowledge there has been no public response about any of the concerns. We think these publications are unreliable ,