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Randomized Controlled Trial
. 2023 Mar 31;15(7):1706.
doi: 10.3390/nu15071706.

Psychobiotic Effects on Anxiety Are Modulated by Lifestyle Behaviors: A Randomized Placebo-Controlled Trial on Healthy Adults

Ricardo Morales-Torres  1 , Cristóbal Carrasco-Gubernatis  2   3 , Aitana Grasso-Cladera  2   3 , Diego Cosmelli  4 , Francisco J Parada  2 , Ismael Palacios-García  2   4
Affiliations
Randomized Controlled Trial

Psychobiotic Effects on Anxiety Are Modulated by Lifestyle Behaviors: A Randomized Placebo-Controlled Trial on Healthy Adults

Ricardo Morales-Torres et al. Nutrients. .

Abstract

Psychobiotics are modulators of the Microbiota-Gut-Brain Axis (MGBA) with promising benefits to mental health. Lifestyle behaviors are established modulators of both mental health and the MGBA. This randomized placebo-controlled clinical trial (NCT04823533) on healthy adults (N = 135) tested 4 weeks of probiotic supplementation (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175). We assessed effects on wellbeing, quality of life, emotional regulation, anxiety, mindfulness and interoceptive awareness. We then analyzed if lifestyle behaviors modulated probiotic effectiveness. Results showed no significant effects of probiotic intake in whole sample outcomes. Correlational analyses revealed Healthy Behaviors were significantly correlated with wellbeing across scales. Moreover, the linear mixed-effects model showed that the interaction between high scores in Healthy Behaviors and probiotic intake was the single significant predictor of positive effects on anxiety, emotional regulation, and mindfulness in post-treatment outcomes. These findings highlight the relevance of controlling for lifestyle behaviors in psychobiotic and mental health research.

Keywords: Mediterranean diet; embodied mind; lifestyle behaviors; mental health; microbiota-gut-brain axis; psychobiotics; well-being.

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Conflict of interest statement

The products (probiotic and placebo) used in this clinical trial were provided by Rosell-Lallemand SAS, France. None of the authors has any financial, commercial, or economical relationship with the funding sponsor.

Figures

Figure 1
Figure 1
Study protocol.
Figure 2
Figure 2
CONSORT flow chart.
Figure 3
Figure 3
Correlation matrix between all variables. Healthy Behaviors (HB) significantly correlates with almost all psychological scales as expected (positively with well-being and interoceptive variables and negatively with anxiety and negative affect). Circles represent significant correlations after correcting for multiple comparisons. Colors blue and red indicate positive and negative values of r, respectively. The size of the circles and the intensity of each color represents the magnitude of the correlation. Abbreviations: STAI, State Trait Anxiety Inventory; RYFF, Ryff Well-being Scale; DERS, Difficulties in Emotional Regulation Scale; SWLS, Satisfaction with Life Scale; PANAS_POS, Positive and Negative Affect Scale, subscale Positive; PANAS_NEG, Positive and Negative Affect Scale, subscale Positive; SF36_PHY, Short Form Health Survey, subscale Physical; SF36_MEN, Short Form Health Survey, subscale Mental; FFMQ, Five Facet Mindfulness Questionnaire; MAIA, Multidimensional Assessment of Interoceptive Awareness Scale.
Figure 4
Figure 4
Linear Regression predicted scores using the linear regression model “Scales~Sex + Age + HB + Treatment+ HB × treatment + HB × treatment × time”. Red and blue colors represent placebo and probiotic groups, respectively. Points represent the values for DERS (a), STAI (b) and FFMQ (c). The shaded region represents the standard error. Abbreviations: STAI, State Trait Anxiety Inventory; DERS, Difficulties in Emotional Regulation Scale; FFMQ, Five Facet Mindfulness Questionnaire; HB, Healthy Behaviors.
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