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Randomized Controlled Trial
. 2023 Jul 5;15(13):3039.
doi: 10.3390/nu15133039.

Effect of a Probiotic and a Synbiotic on Body Fat Mass, Body Weight and Traits of Metabolic Syndrome in Individuals with Abdominal Overweight: A Human, Double-Blind, Randomised, Controlled Clinical Study

Christiane Laue  1 , Ekaterina Papazova  1 , Angelika Pannenbeckers  1 , Jürgen Schrezenmeir  1   2
Affiliations
Randomized Controlled Trial

Effect of a Probiotic and a Synbiotic on Body Fat Mass, Body Weight and Traits of Metabolic Syndrome in Individuals with Abdominal Overweight: A Human, Double-Blind, Randomised, Controlled Clinical Study

Christiane Laue et al. Nutrients. .

Abstract

L. fermentum strains K7-Lb1, K8-Lb1 and K11-Lb3 were found to suppress Th1 and Th2 response and to enhance defensin release by enterocytes, respectively. Based on these anti-inflammatory actions, we investigated the effect of these strains on traits of metabolic syndrome, which is driven by low-grade inflammation. In a double-blind, randomised, placebo-controlled clinical trial with three parallel arms, 180 individuals with abdominal overweight were administered for 3 months with (1) placebo; (2) probiotic, comprising L. fermentum strains; or (3) synbiotic, comprising the strains + acacia gum (10 g daily). The effects were evaluated using Kruskal-Wallis one-way analysis of variance on ranks and post hoc tests (Holm-Sidak and Dunn's tests). The alteration (∆) in body fat mass (kg) (primary parameter) during intervention was significantly (p = 0.039) more pronounced in the Probiotic group (-0.61 ± 1.94; mean ± SD) compared with the Placebo group (+0.13 ± 1.64). Accordingly, differences were found in ∆ body weight (p = 0.012), BMI (p = 0.011), waist circumference (p = 0.03), waist-to-height ratio (p = 0.033), visceral adipose tissue (SAD) (p < 0.001) and liver steatosis grade (LSG) (p < 0.001), as assessed using sonography. In the Synbiotic group, ∆SAD (p = 0.002), ∆LSG (p < 0.001) and ∆constipation score (p = 0.009) were improved compared with Placebo. The probiotic mixture and the synbiotic improved the parameters associated with overweight.

Keywords: L. fermentum; NAFLD; body fat mass; metabolic syndrome; probiotics; synbiotics; weight management.

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Conflict of interest statement

J.S. is co-inventor of the patents EP 2464361, US 14/708,942 and ARIPO AP 3282, which protect the use of the pertinent L. fermentum strains in inflammatory conditions such as obesity, traits of the metabolic syndrome and liver steatosis. The patent is owned by Slimbiotics GmbH. The study was sponsored by Slimbiotics GmbH, Vienna, Austria. The sponsors had no role in the design, execution, interpretation, or writing of the study. J.S. acts as consultant at Slimbiotics GmbH.

Figures

Figure 1
Figure 1
Summary of the study design.
Figure 2
Figure 2
Flow diagram of the study progress through the different phases (according to CONSORT).
Figure 3
Figure 3
Alteration in body fat mass (∆ BFM) (kg) (primary parameter) during intervention, as assessed with bioimpedance (BIA). Means ± SEMs. * p = 0.039 in Holm–Sidak.
See this image and copyright information in PMC

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