The effects of probiotic supplementation on metabolic status in type 2 diabetic patients with coronary heart disease
Authors: Vahidreza Ostadmohammadi
Zohreh Rezavandi
Zatollah Asemi
Mohammad Ali Mansournia
Shokoofeh Borzabadi
Fariba Raygan
Maryam Tajabadi-Ebrahimi
Fereshteh Bahmani
Journal: Diabetology & Metabolic Syndrome (2018)
Discipline: CLINICAL MEDICINE
Keywords: Coronary heart disease; Metabolic status; Probiotic; Type 2 diabetes mellitus.
Affiliations: 1Department of Cardiology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran., 2Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran., 3Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran., 4Science Faculty, Islamic Azad University, Central Branch, Tehran, Iran., 5Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.

Abstract:  Background: This study was conducted to evaluate the effects of probiotic supplementation on metabolic profiles in diabetic patients with coronary heart disease (CHD). Methods: This randomized, double-blind, placebo-controlled trial was performed among 60 diabetic patients with CHD, aged 40-85 years at a cardiology clinic in Kashan, Iran, from October 2017 through January 2018. Patients were randomly divided into two groups to take either probiotic supplements (n = 30) or placebo (n = 30) for 12 weeks. Fasting blood samples were taken at the beginning of the study and after the 12-week intervention to determine related markers. Results: After 12-week intervention, probiotic supplementation significantly decreased fasting plasma glucose (Œ≤ - 20.02 mg/dL; 95% CI - 33.86, - 6.17; P = 0.005), insulin (Œ≤ - 2.09 ¬µIU/mL; 95% CI - 3.77, - 0.41; P = 0.01), insulin resistance (Œ≤ - 0.50; 95% CI - 0.96, - 0.03; P = 0.03) and total-/HDL-cholesterol ratio (Œ≤ - 0.27; 95% CI - 0.52, - 0.03; P = 0.02), and significantly increased insulin sensitivity (Œ≤ 0.008; 95% CI 0.001, 0.01; P = 0.02) and HDL-cholesterol levels (Œ≤ 2.52 mg/dL; 95% CI 0.04, 5.00; P = 0.04) compared with the placebo. Moreover, probiotic supplementation led to a significant reduction in serum high sensitivity C-reactive protein (Œ≤ - 0.88 mg/L; 95% CI - 1.39, - 0.38; P = 0.001), and a significant elevation in total antioxidant capacity (Œ≤ 108.44 mmol/L; 95% CI 47.61, 169.27; P = 0.001) and total glutathione levels (Œ≤ 45.15 ¬µmol/L; 95% CI 5.82, 84.47; P = 0.02) compared with the placebo. Probiotic supplementation did not affect other metabolic profiles. Conclusions: Overall, we found that probiotic supplementation for 12 weeks had beneficial effects on glycemic control, HDL-cholesterol, total-/HDL-cholesterol ratio, biomarkers of inflammation and oxidative stress in diabetic patients with CHD.Trial registration Clinical trial registration number http://www.irct.ir: IRCT2017082733941N5. 

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 A161 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. 18 publications have an expression of concern, and 6 have been retracted. To our knowledge there has been no public response about any of the concerns. We think these publications are unreliable ,