Lacticaseibacillus paracasei Lpc-37® improves psychological and physiological markers of stress and anxiety in healthy adults: a randomized, double-blind, placebo-controlled and parallel clinical trial (the Sisu study)
- 2020-11
- Neurobiology of Stress 13
- E. Patterson
- Síle M. Griffin
- A. Ibarra
- E. Ellsiepen
- J. Hellhammer
- PubMed: 33385020
- DOI: 10.1016/j.ynstr.2020.100277
Abstract
Chronic stress is a risk-factor for the development of mood and stress-related disorders. Clinical evidence indicates that probiotics can influence the stress response and mood. The Sisu study investigated whether Lacticaseibacillus paracasei Lpc-37® (Lpc-37®) could modulate stress, mood and well-being. Prior to a two-week run-in period, 120 healthy adults (18-45 y) were stratified for sex and chronic stress and randomized to either 1.75 × 1010 colony forming units (CFU) of Lpc-37 or placebo (1:1) per day for 5 weeks. The primary objective was the effect of Lpc-37 on heart rate (HR) in response to the Trier Social Stress Test (TSST). Secondary objectives were assessed by biomarkers and self-report scales over the study. The primary hypothesis was not met in either the Intention-to-Treat (ITT) or Per Protocol (PP) population, but Lpc-37 reduced the increase in HR in participants with low chronic stress (LCS) and increased HR in participants with high chronic stress (HCS) during the TSST. Supporting significant efficacy in the PP population (n = 113), Lpc-37 reduced perceived stress following intervention. More significant effects were identified within the subgroups where Lpc-37 reduced exhaustion during the TSST and normalized cortisol levels at 8pm in participants with LCS, reduced perceived stress also in females, and increased perceived health and sleep-related recovery in participants with HCS. Adverse events (AEs) were similar between groups, there were no severe AEs, and vital signs remained unchanged. Overall, Lpc-37 reduced perceived stress compared to placebo. Other beneficial effects within biomarkers related to stress indicate that the effects of Lpc-37 may be differentially dependent on sex and chronic stress. (ClinicalTrials.gov: NCT03494725).
Keywords: Anxiety; Lacticaseibacillus paracasei Lpc-37; Probiotic; Stress; Trier Social Stress Test.
Research Insights
| Supplement | Health Outcome | Effect Type | Effect Size |
|---|---|---|---|
| Lacticaseibacillus paracasei Lpc-37 | Improved Perceived Health | Beneficial | Moderate |
| Lacticaseibacillus paracasei Lpc-37 | Improved Sleep-Related Recovery in Participants with High Chronic Stress | Beneficial | Moderate |
| Lacticaseibacillus paracasei Lpc-37 | Normalized Evening Cortisol Levels in Low Chronic Stress Participants | Beneficial | Moderate |
| Lacticaseibacillus paracasei Lpc-37 | Reduced Exhaustion | Beneficial | Moderate |
| Lacticaseibacillus paracasei Lpc-37 | Reduced Perceived Stress | Beneficial | Large |
| Lactobacillus paracasei LPC09 | Absence of Severe Adverse Events | Neutral | Large |
| Lactobacillus paracasei LPC09 | Normalized Cortisol Levels | Beneficial | Moderate |
| Lactobacillus paracasei LPC09 | Reduced Exhaustion During Stress Test | Beneficial | Moderate |
| Lactobacillus paracasei LPC09 | Reduced Perceived Stress | Beneficial | Large |