Randomized controlled trial demonstrates response to a probiotic intervention for metabolic syndrome that may correspond to diet

ABSTRACT

An individual’s immune and metabolic status is coupled to their microbiome. Probiotics offer a promising, safe route to influence host health, possibly via the microbiome. Here, we report an 18-week, randomized prospective study that explores the effects of a probiotic vs. placebo supplement on 39 adults with elevated parameters of metabolic syndrome. We performed longitudinal sampling of stool and blood to profile the human microbiome and immune system. While we did not see changes in metabolic syndrome markers in response to the probiotic across the entire cohort, there were significant improvements in triglycerides and diastolic blood pressure in a subset of probiotic arm participants. Conversely, the non-responders had increased blood glucose and insulin levels over time. The responders had a distinct microbiome profile at the end of the intervention relative to the non-responders and placebo arm. Importantly, diet was a key differentiating factor between responders and non-responders. Our results show participant-specific effects of a probiotic supplement on improving parameters of metabolic syndrome and suggest that dietary factors may enhance stability and efficacy of the supplement.

KEYWORDS:

• Microbiome
• microbiota
• probiotic
• diet
• metabolic syndrome
• metabolomics
• immune profiling

Data and code availability

Datasets and code for analysis are available at https://github.com/SonnenburgLab/project-probiotic-study/. Raw data files for 16S and metagenomic sequencing available at BioProject database

Acknowledgments

The authors thank the study participants for their engagement and essential contribution to the study. Maha El-Sayed, Bill King and Zac Lewis were instrumental to probiotic formulation considerations and study design. We appreciate Diane Demis and Erin Avery for providing support in recruitment, study logistics, and aiding participant retention and Bryan Merrill for technical scientific support. This manuscript is derived from work presented in the dissertation of Hannah C. Wastyk entitled Determining Causal Relationships Between the Microbiome and Immune System⁵. Funding was provided by The Clorox Company.

Disclosure statement

Funding for this study was supported by The Clorox Company, JLS is a Chan Zuckerberg Biohub Investigator. To reduce bias on the outcome of the study, a study plan was submitted to ct.gov. Clorox was not involved in the analysis or presentation of the study data.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/19490976.2023.2178794

Additional information

Funding

This work was supported by a sponsored research agreement with The Clorox Company.