title: The use of probiotic L. fermentum ME-3 containing Reg'Activ Cholesterol supplement for 4 weeks has a positive influence on blood lipoprotein profiles and inflammatory cytokines: an open-label preliminary study.
abstract: Cardiovascular diseases continue to be a challenge and burden to heath. The incidence of type 2 diabetes is increasing. Modifying the (common) risk factors of them is the key of longterm success. The aim of the study was to establish if the special composition of innovative food supplement Reg'Activ Cholesterol (RAC) has a positive influence to the human body cardiovascular-inflammatory and diabetic parameters.
  
  
  
  Forty-five clinically asymptomatic participants consumed an RAC containing an antioxidative and antiatherogenic probiotic Lactobacillus fermentum ME-3 (LFME-3) for 4 weeks. The parameters measured were total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, oxLDL, hsCRP, IL-6 and glycosylated haemoglobin (HbA1c%).
  
  
  
  The cardiovascular and diabetes risk profile of the participants improved significantly after 4 weeks of the intervention. The reduction of total cholesterol (from 6.5 ± 1.0 to 5.7 ± 0.9 mmol/l, p = 9.90806E-11) was on the account of LDL cholesterol as the HDL cholesterol level rose from 1.60 ± 0.31to 1.67 ± 0.34mml/l, p = 0.01. HbA1c% was reduced from 5.85 ± 0.28 to 5.66 ± 0.25 p = 4.64E-05 and oxLDL decreased from 84 ± 20 to 71 ± 15 U/l, p = 4.66292E-08.
  
  
  
  The consumption of RAC in clinically asymptomatic volunteers with borderline-high values of risk factors for cardiovascular disease (BMI, HbA1c%, LDL cholesterol) for 4 weeks had a positive effect on blood lipoprotein, oxidative stress and inflammatory profile. There are no human trials published before with RAC.
  
  
  
  The trial described here isa n open label pilot study within the framework of a larger special clinical trial ( ISRCTN55339917 ) [Accessed 20 Feb 2016].
authors: Department of Biochemistry, Institute of Biomedicine and Translational Medicine, The Centre of Excellence for Genomics and Translational Medicine, Faculty of Medicine, University of Tartu, Ravila 19, Tartu, 50411, Estonia.
authors: Tiiu
authors: T
authors: Kullisaar
authors: Department of Biochemistry, Institute of Biomedicine and Translational Medicine, The Centre of Excellence for Genomics and Translational Medicine, Faculty of Medicine, University of Tartu, Ravila 19, Tartu, 50411, Estonia.
authors: Kersti
authors: K
authors: Zilmer
authors: Department of Biochemistry, Institute of Biomedicine and Translational Medicine, The Centre of Excellence for Genomics and Translational Medicine, Faculty of Medicine, University of Tartu, Ravila 19, Tartu, 50411, Estonia.
authors: Tiit
authors: T
authors: Salum
authors: Department of Biochemistry, Institute of Biomedicine and Translational Medicine, The Centre of Excellence for Genomics and Translational Medicine, Faculty of Medicine, University of Tartu, Ravila 19, Tartu, 50411, Estonia. aune.rehema@ut.ee.
authors: Aune
authors: 0000-0003-3064-1653
authors: A
authors: Rehema
authors: Department of Biochemistry, Institute of Biomedicine and Translational Medicine, The Centre of Excellence for Genomics and Translational Medicine, Faculty of Medicine, University of Tartu, Ravila 19, Tartu, 50411, Estonia.
authors: Mihkel
authors: M
authors: Zilmer
mesh_terms: D000368:Aged; D000975:Antioxidants / Q000008:administration & dosage*; D002318:Cardiovascular Diseases / Q000517:prevention & control; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D016207:Cytokines / Q000097:blood*; D019587:Dietary Supplements; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007249:Inflammation / Q000097:blood*; D052197:Limosilactobacillus fermentum; D008074:Lipoproteins / Q000097:blood*; D008077:Lipoproteins, LDL / Q000097:blood; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D019936:Probiotics / Q000008:administration & dosage*
chemical_list: D000975:Antioxidants; D002784:Cholesterol; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D016207:Cytokines; D006442:Glycated Hemoglobin; D008074:Lipoproteins; D008077:Lipoproteins, LDL; C099252:oxidized low density lipoprotein
keywords: Blood serum lipid profile; HbA1c%; Human clinical trial; L. fermentum ME-3; Oxidized LDL