Table 1.
Summary of anti-obesity effects of probiotics reported in randomized controlled clinical trials.
| Author/Year | Study Design | Population Characteristics | Intervention | Control/Placebo Group | Duration | Clinical Findings (vs. Control/Placebo Group) |
|---|---|---|---|---|---|---|
| Alisi et al. (2014) [86] | Parallel-arm, double-blind RCT | Children aged 11 years with NAFLD (n = 44); intervention (n = 22); placebo (n = 22) | VSL#3 (450 billion bacteria per sachet, one sachet/day) + low calorie diet + moderate physical activity | 1 cap/day + healthy habits (low calorie diet + moderate physical activity) | 4 months | <BMI, fatty liver, insulin resistance; >GLP-1 |
| Aller et al. (2011) [97] | Randomized, double-blind, parallel, placebo-controlled trial | Patients with NAFLD (n = 28) | 500 million of Lactobacillus bulgaricus and Streptococcus thermophilus (1 tablet/day) | 1 cap/day of starch | 3 months | Improved liver function, glucose metabolism and pro-inflammatory markers; no changes in anthropometric measures |
| Famouri et al. (2017) [87] | Triple-blind randomized placebo-controlled clinical trial | Obese children and adolescents (12.7 years) with NAFLD (n = 64); intervention (n = 32); placebo (n = 32) | L. acidophilus ATCC B3208 (3 × 109 CFU), L. rhamnosus DSMZ21690 (6 × 109 CFU), B. lactis DSMZ 32,296 (2 × 109 CFU) and B. bifidum ATCC SD6576 (2 × 109 CFU) cap/day + healthy lifestyle habits | 1 cap/day of placebo + healthy lifestyle habits | 12 weeks | =BMI, weight; <WC |
| Gomes et al. (2017) [92] | Randomized, double-blind, placebo-controlled, two arm, parallel-group clinical trial | Obese women aged 20–59 years (n = 43); intervention (n = 21); placebo (n = 22) | L. acidophilus LA-14, L. casei LC-11, Lactococcuslactis LL-23, B. bifidum BB-06, B. lactis BL-4 (2 × 1010 CFU/day) + dietary intervention | 1 cap/day placebo + dietary prescription | 8 weeks | =BMI and weight; <WC |
| Higashikawa et al. (2016) [93] | Randomized, double-blind, placebo-controlled clinical trial | Overweight adults aged 20–70 years (n = 62); Intervention I (n = 21); Intervention II (n = 21); placebo (n = 20) | Intervention I: Living LP28; Intervention II Heat-killed LP28 (Pediococcus pentosaceus) (1011 CFU/day) |
1 cap/day placebo | 12 weeks | <BMI, WC after Intervention II |
| Jung et al. (2015) [91] | Double-blind, placebo-controlled, randomized clinical trial | Obese adults aged 20–65 years (n = 120); intervention (n = 60); placebo (n = 60) | L.curvatus HY7601 + L. plantarum KY1032 (2.5 × 109 CFU of probiotics/2 cap/day) + healthy lifestyle habits | 2 cap/day placebo + healthy lifestyle habits | 12 weeks | <Body weight, WC and fat |
| Kadooka et al. (2010) [98] | Multicenter, double-blind, randomized, placebo-controlled intervention trial | Adults aged 33-63 years with obese tendencies (n = 87); intervention (n = 43); control group (n = 44) | Fermented milk containing Lactobacillus gasseri SBT2055 (5 × 1010 CFU/100 g fermented milk). Intake of 200 g/day | Intake of 200 g/day of fermented milk without probiotic | 12 weeks | <Abdominal visceral, subcutaneous fat areas, body weight and BMI |
| Kim et al. (2018) [94] | Randomized, double-blind, placebo-controlled trial | Obese adults aged 20–75 years (n = 90); low-dose intervention (n = 30); high-dose intervention (n = 30); placebo (n = 30) | Low (109 CFU/day) and high (1010 CFU/2 cap/twice a day) dose of Lactobacillus gasseri BNR17 + lifestyle changes | 2 cap/twice a day of placebo + lifestyle changes | 12 weeks | <Visceral adipose tissue; WC in high-dose group; <WC in low-dose group |
| Luoto et al. (2010) [84] | Randomized, double-blind, prospective follow-up study | Mother–child pairs (n = 113); intervention (n = 54); placebo (n = 59) | Lactobacillus rhamnosus GG (1 × 1010 CFU/day) | 1 cap/day of placebo (microcrystalline cellulose) | Mothers 4 weeks before expected delivery; in infants up to 6 month old | <Weight gain at 1 year of life and 4 years; no changes in later stages of development |
| Minami et al. (2018) [95] | Randomized, double-blind, placebo-controlled trial | Healthy pre-obese adults aged 20–64 years (n = 80); intervention (n = 40); placebo (n = 40) | Bifidobacterium breve B-3 (1010 CFU/2 cap/day) | 2 cap/day of placebo | 12 weeks | <Body fat mass |
| Mykhal´chyshyn et al. (2013) [99] | Open label study | Adult patients with T2D and NAFLD (n = 72); intervention (n = 45); control group (n = 27) | “Symbiter” containing concentrated biomass of 14 alive probiotic bacteria + oral antidiabetic therapy | Only hypoglycemic drugs | 4 weeks | <Pro-inflammatory markers; no changes in anthropometric measures |
| Osterberg et al. (2015) [100] | Randomized, double-blind placebo-controlled clinical trial | Healthy non-obese young male adults (18–30 years) (n = 20); intervention (n = 9); placebo (n = 11) | Two sachets of VSL#3 (450 billion bacteria per sachet in milk shake/once a day) + high fat diet (HFD) | Two sachets of placebo in milk shake/once a day + HFD | 4 weeks | <Weight and fat |
| Pedret et al. (2018) [96] | Randomized, parallel, double-blind, placebo-controlled trial | Abdominally obese adults (n = 126); Intervention I (n = 42); Intervention II (n = 44); placebo (n = 40) | Bifidobacterium animalis subsp. Lactis CECT 8145 (Intervention I) or its heat-killed form (Intervention II) (1010 CFU/cap/day) | 1 cap/day of placebo | 3 months | <BMI, WC and waist circumference/height ratio; no differences between live and heat-killed form |
| Sánchez et al. (2017) [101] | Double-blind, randomized, placebo-controlled trial | Obese adults aged 18–55 years (n = 125); intervention (n = 62); placebo (n = 63) | L. rhamnosus CGMCC1.3724 (1.62 × 108 CFU/2 cap/day) + healthy eating behavior | 250 mg of maltodextrin + 3 mg magnesium stearate + healthy eating behavior | 12 weeks | <Weight |
| Sanchis-Chordá et al. (2018) [88] | Double-blind, randomized, placebo-controlled trial | Obese children (aged 10–15 years) with insulin resistance (n = 48); intervention (n = 23); placebo (n = 25) | B. pseudocatenulatum CECT 7765 (109−10 CFU/day) + dietary recommendations | Placebo + dietary recommendations | 13 weeks | <Weight body |
| Szulinska et al. (2018) [102] | Randomized-double-blind, placebo-controlled clinical trial | Obese postmenopausal women aged 45–70 years (n = 81); low-dose intervention (n = 27); high-dose intervention (n = 27); placebo (n = 27) | Low (2.5 × 109 CFU/day) and high dose (1010 CFU/day/two sachets per day) of probiotic mixture including nine different strains of Lactobacillus and Bifidobacterium | 1 cap/day of placebo | 12 weeks | <Body weight, BMI and fat mass in low and high-dose group; improved lipid metabolism in the high-dose group |
| Vajro et al. (2011) [85] | Double-blind, placebo-controlled pilot study | Obese children (aged 10–13 years) with hypertransaminasemia and ultrasonographic bright liver (n = 20); intervention (n = 10); placebo (n = 10) | Lactobacillus rhamnosus GG (12 billion CFU/day) | 1 cap/day of placebo | 8 weeks | <Hypertransaminasemia Effects on BMI and visceral fat in combination with lifestyle interventions |
BMI: body mass index; CFU: colony-forming units; GLP-1: glucagon-like peptide-1; NAFLD: non-alcoholic fatty liver disease; T2D: type 2 diabetes; WC: waist circumference.