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. 2021 Mar 17;9(3):618. doi: 10.3390/microorganisms9030618

Table 1.

Summarizing the published data related to the clinical trials considering the effects of pre-/probiotics on the associated risk factors to MetS development.

Type of the Controlled Trial Form of the Product; Species/Active Substance; Period of Administration, Dose of Pre/Probiotic Effects/Actions Ref.
Dyslipidemia
Randomized double-blind placebo, crossover Lyophilized probiotic culture capsules; Bifidobacterium animalis ssp. lactis MB 2409 (DSM 23733) + Bifidobacterium MB 109 (DSM 23731) + Bifidobacterium longum ssp. longum BL04 (DSM 23233) (109 CFU/g); 12 weeks, 1/day ↓: LDL-C, TC
↑: HDL-C		 [72]
Randomized double-blind placebo Lyophilized symbiotic capsules; Lactobacillus acidophilus CHO-220 (109 CFU/g) + 0.2 g Inulin; 12 weeks, 4/day ↓: LDL-C, TC [73]
Hypercholesterolemia
Single-arm, open-label pilot study Probiotic culture capsules; Saccharomyces cerevisiae var. boulardii CNCM I-1079 (1.4 × 1010 CFU); 8 weeks, 2/day ↓: RLP-P [74]
Hypertensive adults
Double-blind placebo Fruit drink with probiotic bacteria; Lactobacillus plantarum DSM 15313; 1 × 109 CFU/day dose; 12 weeks, 1/day Not effective: BP parameters [75]
Yogurt; Enterococcus faecium + Streptococcus thermophilus 4.7 × 1011; 8 weeks ↓: SBP, DBP [76]
Sour milk; Lactobacillus helveticus + Saccharomyces cerevisiae; 7 × 1010; 8 weeks [77]
Capsules; Lactobacillus reuteri 5.8 × 109; 8 weeks [78]
Cheese; L. plantarum 7.5 × 1012; 3 weeks [79]
Hypertensive overweight women
Double blind, randomized Cheese with probiotic bacteria/Lactobacillus casei 01 (108 CFU/g); 4 weeks, 1/day ↓: TC, LDL-C, TG, SBP, DBP
↑: HB, HDL-C, HE		 [80]
Metabolic syndrome
Randomized double-blind placebo Pre/probiotic culture in yogurt/milk; Bifidobacterium lactis Bb-12 (107 CFU/g) + 6 g inulin; 10 weeks, 2/day ↓: BFM, BFP, HOMA-IR, TG, WC,
↑: 25(OH)D, HDL-C, QUICKI		 [81]
Pro/synbiotics culture in packages; Lactobacillus acidophilus + Bifidobacterium bifidum + Bifidobacterium lactis + Bifidobacterium longum (1.5 × 109 each); 24 weeks, 6 g/day
Observation: synbiotics (containing the above-mentioned probiotics) + inulin (prebiotic)		 ↓: HDL-C (probiotic group) [82]
Probiotic culture in yogurt/milk; Bifidobacterium lactis Bb-12 (3.6 × 106 CFU/300 g) + Lactobacillus acidophilus La-5 (4.4 × 106 CFU/300 g); 8 weeks, 1/day ↓: BG, INS, HOMA-IR
↑: QUICKI		 [83]
Milk; Lactobacillus casei; 108 cells/mL, 65 mL bottles × 3/day, 12 weeks ↑: High-sensitive CRP (1.86 mg/L (probiotic group) vs. −1.60 mg/L (placebo group), p = 0.016); LBP levels (5827 ng/mL (probiotic group) vs. −1510 ng/mL (placebo group), p = 0.023) [84]
Cheese; Lactobacillus plantarum; 1.5 × 1011 CFU/g, 50 g/day, 12 weeks ↓: BMI (−2 (probiotic group) vs. −1.6 kg/m2 (placebo group), p = 0.031 [79]
Milk; Lactobacillus casei; 108 cells/mL, 65 mL bottles × 3/day, 12 weeks ↓: sVCAM-1 level (−195 ng/mL (probiotic group) vs. 30 ng/mL (placebo group), p = 0.008
↑: high-sensitive CRP level (1.86 mg/L (probiotic group) vs. −1.60 mg/L (placebo group), p = 0.002		 [85]
Milk; Lactobacillus plantarum; 107 CFU/g, 80 mL bottles × 1/day, 12 weeks ↓: Glucose levels in FM group vs. NFM group (−10.5 (FM group) vs. −3 mg/dL (NFM group), p = 0.037 [86]
Milk; Bifidobacterium lactis; 3.4 × 108 CFU/mL, 80 mL bottle × 1/day, 6 weeks ↓: BMI variation (−1.3 (probiotic group) vs. −0.3 kg/m2 (control group) p = 0.017); TC (−15 (probiotic group) vs. 6 mg/dL (control group), p = 0.09); LDL-C (−17.5 (probiotic group) vs. −2 mg/dL (control group), p = 0.08) [87]
Randomized double-blind placebo, cluster cross-over Probiotic culture in fermented milk;
Bifidobacterium animalis ssp. lactis HN019; 45 days, 1/day, 2.72 × 1010 CFU/mL		 ↓: BMI, TC, TNF-α, IL-6, LDL-C [87]
Overweight/obesity
Randomized double-blind placebo Prebiotic packages; 0.29 g oligofructose/kg body weight + 0.14 g oligofructose/kg body weight; 120 days, 1/day ↓: BMI, BW, INS, HOMA-IR, LDL-C, WC [88]
Lyophilized probiotic culture capsules;
Lactobacillus gasseri BNR17; 12 weeks, 2/day, 400 mg/capsule of low dose (109 CFU) or high dose (1010 CFU); 		↓: VAT (high dose), WC in both dose (high and low) [89]
Prebiotic packages; 2 g oligofructose; 12 weeks, 1/day ↓: BG, BW, INS [90]
Randomized, controlled, parallel, double-blind, factorial trial Lyophilized probiotic cultures yoghurt/capsules; Lactobacillus acidophilus La-5 (3 × 109 CFU) + Bifidobacterium animalis Bb-12 (3 × 109 CFU); 6 weeks, 1/day Not effective: lipid profile, BP [90]
T2DM
Randomized double-blind placebo Prebiotic packages; 10 g chicory inulin + oligofructose; 8 weeks, 1/day ↓: AST, ALP, DBP, FSG, HbA1c, SBP, SC [91]
Prebiotic packages; 10 g oligofructose + inulin; 8 weeks, 1/day ↓: BMI, DBP, IFN-γ, IL-12, WC,
↑: IL-4		 [92]
Symbiotic packages/Lactobacillus acidophilus
(2 × 109 CFU) + Lactobacillus casei (7 × 109 CFU)
+ Lactobacillus bulgaricus (2 × 108 CFU) + Lactobacillus rhamnosus (1.5 × 109 CFU) + Bifidobacterium breve (3 × 1010 CFU) + Bifidobacterium longum
(7 × 109 CFU) + Streptococcus thermophilus
(1.5 × 109 CFU) + 100 mg oligofructose; 6 weeks, 1/day		 ↓: FPG
↑: HDL-C		 [93]
Symbiotic packages; Lactobacillus + Bifidobacterium (1010 CFU/g) + Lactococcus (6 × 1010 CFU/g) + Propionibacterium (3 × 1010 CFU/g) + Acetobacter (1 × 106 CFU/g); 8 weeks, 1/day ↓: HOMA-IR, IL-1β, TNF-α [94]
Probiotic yogurt; L. acidophilus La-5, B. lactis Bb-12; 8 weeks, 300 g/day, 3.7 × 106 CFU/mg for both organisms ↓: FBG, HbA1c [95]
Dietary supplements, Lactobacillus reuteri DSM 17938; 12 weeks, low dose (108 CFU)/high dose (1010 CFU), ↓: HbA1c, insulin sensitivity index [11]
Probiotic fermented milk; Lactobacillus casei, L. acidophilus, bifidobacterial; 8 weeks, 300 mL/day ↓: FBG, HbA1c [96]
Probiotic bread; Lactobacillus sporogenes; 8 weeks, 120 g/day, 1 × 108 CFU/g) ↓: FBG, insulin, HOMA-IR, HOMA–B, QUICKI [97]
Tablets; Saccharomyces cerevisiae; 12 weeks, 1800 mg/day = 6 tablets ↓: FBG, HbA1c, HOMA- IR, QUICKI, [98]
Randomized double-blind placebo crossover Synbiotic packages; Lactobacillus sporogenes
(107 CFU/g) + 0.05 g β-carotene + 0.1 g inulin; 6 weeks, 3/day		 ↓: INS, HOMA-B, HOMA-IR, TC/HDL-C ratio, TG, VLDL-C [99]
Randomized triple-blind placebo Prebiotic packages; 10 g Inulin; 8 weeks, 1/day ↓: FSG, HbA1c, HOMA-IR, hs-CRP, INS, TNF-α, LPS [100]
T2DM + CHD
Randomized double-blind placebo Probiotics culture and Se packages;
200 μg/day Se + 8 × 109 CFU/g probiotic (Lactobacillus acidophilus + Lactobacillus reuteri + Lactobacillus fermentum + Bifidobacterium bifidum (2 × 109 CFU/g each); 12 weeks, 1/day		 ↓: FPG, HOMA-IR (probiotic + Se), hs-CRP, INS, TC, TG, VLDL-C,
↑: GSH, NO, TAC, (co-supplementation)		 [101]

Legend: ↑—increase;↓—reduction/decrease; 25(OH)D—25-hydroxyvitamin D; ALP—alkaline phosphatase; AST—aspartate aminotransferase; AV—abdominal visceral; BFM—body fat mass; BFP—body fat percentage; BG—blood glucose; BMI—body mass index measure; BP—blood pressure; BW—body weight; CFU—colony forming unit; CHD—coronary heart disease; DBP—diastolic blood pressure; FPG—fasting plasma glucose; FSG—fasting serum/blood glucose; GPA—glutathione peroxidase activities; GSH—total glutathione; HB—hemoglobin; HbA1c—glycated hemoglobin; HDL-C—high-density lipoprotein cholesterol; HE—hematocrit; HOMA-B—homeostasis model assessment index-β-cell; HOMA-IR—homeostasis model assessment index-insulin resistance; hs-CRP—high-sensitive C-reactive protein; IFN-γ—interferons-γ; IL-1β—interleukin-1β; IL-2—interleukin-2; IL-4—Interleukin-4; INS—insulin; LDL-C—low-density lipoprotein cholesterol; LPS—lipopolysaccharides; NO—nitric oxide; QUICKI—quantitative insulin sensitivity check index; RLP-P—remnant lipoprotein particle; SBP—systolic blood pressure; SC—serum calcium; Se—selenium; SFA—subcutaneous fat areas; T2DM—type 2 diabetes mellitus; TAC—total antioxidant capacity; TAS—total antioxidant status; TC—total cholesterol; TG—triglycerides; TNF-α—tumor necrosis factor alpha; VAT—visceral adipose tissue; VLDL-C—very low-density lipoprotein cholesterol; WC—waist circumference.