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Randomized Controlled Trial
. 2024 Dec;21(1):2409682.
doi: 10.1080/15502783.2024.2409682. Epub 2024 Oct 1.

The effects of AG1® supplementation on the gut microbiome of healthy adults: a randomized, double-blind, placebo-controlled clinical trial

Michael B La Monica  1 , Betsy Raub  1 , Shelley Hartshorn  1 , Ashley L Gustat  1 , Jodi Grdic  1 , Trevor O Kirby  2 , Jeremy R Townsend  2   3 , Jen Sandrock  1 , Tim N Ziegenfuss  1
Affiliations
Randomized Controlled Trial

The effects of AG1® supplementation on the gut microbiome of healthy adults: a randomized, double-blind, placebo-controlled clinical trial

Michael B La Monica et al. J Int Soc Sports Nutr. 2024 Dec.

Abstract

Background: This study aimed to examine the effect of a commercially available multi-ingredient powder (AG1Ⓡ) on the gut microbiome and assess the impact of AG1Ⓡ on GI tolerability and other clinical safety markers in healthy men and women.

Methods: Using a double-blind, randomized, two-arm, placebo-controlled, parallel design, we examined a 4-week daily supplementation regimen of AG1Ⓡ vs. placebo (PL). Fifteen men and 15 women provided stool samples for microbiome analysis, questionnaires for digestive quality of life (DQLQ), and completed visual analog scales (VAS) and Bristol stool charts to assess stool consistency and bowel frequency before and after the 4-week intervention. Participant's blood work (CBC, CMP, and lipid panel) was also assessed before and after the 4-week intervention. Alpha diversity was determined by Shannon and Chao1 index scores and evaluated by a two-way ANOVA, beta diversity in taxonomic abundances and functional pathways was visualized using partial least squares-discriminant analyses and statistically evaluated by PERMANOVA. To identify key biomarkers, specific feature differences in taxonomic relative abundance and normalized functional pathway counts were analyzed by linear discriminant analysis (LDA) effect size (LEfSe). Questionnaires, clinical safety markers, and hemodynamics were evaluated by mixed factorial ANOVAs with repeated measures. This study was registered on clinicaltrials.gov (NCT06181214).

Results: AG1Ⓡ supplementation enriched two probiotic taxa (Lactobacillus acidophilus and Bifidobacterium bifidum) that likely stem from the probiotics species that exist in the product, as well as L. lactis CH_LC01 and Acetatifactor sp900066565 ASM1486575v1 while reducing Clostridium sp000435835. Regarding community function, AG1Ⓡ showed an enrichment of two functional pathways while diminishing none. Alternatively, the PL enriched six, but diminished five functional pathways. Neither treatment negatively impacted the digestive quality of life via DQLQ, bowel frequency via VAS, or stool consistency via VAS and Bristol. However, there may have been a greater improvement in the DQLQ score (+62.5%, p = 0.058, d = 0.73) after four weeks of AG1Ⓡ supplementation compared to a reduction (-50%) in PL. Furthermore, AG1Ⓡ did not significantly alter clinical safety markers following supplementation providing evidence for its safety profile.

Conclusions: AG1Ⓡ can be consumed safely by healthy adults over four weeks with a potential beneficial impact in their digestive symptom quality of life.

Keywords: Gut health; dietary supplementation; gastrointestinal symptoms; microbiome; prebiotics; probiotics.

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Conflict of interest statement

T.N.Z. has no direct conflict in terms of financial or business interests related to the topic of this publication. J.R.T. and T.N.Z. have received funding from dietary supplement companies for research, honoraria for speaking at conferences, and fees for writing articles and consulting. T.O.K. and J.R.T. are employees of Athletic Greens International. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a conflict of interest. The funders had no role in the collection, analyses, or interpretation of the data from the questionnaires, clinical safety markers, or adverse events.

Figures

Figure 1.
Figure 1.
Study design overview. GI: Gastrointestinal; PL: Placebo.
Figure 2.
Figure 2.
Alpha diversity analyses on fecal microbiota before and after supple-mentation. (a) Shannon diversity index values; (b) Chao1 diversity index values.
Figure 3.
Figure 3.
A PLS-DA ordination visualizes the effects of treatment and time influenced on community structural heterogeneity. Numbers 1 through 15 (orange) refer to the AG1® treated individuals at baseline sampling and numbers 16 through 30 (green) refer to the placebo (PL) treated individuals at baseline. Numbers 31 through 45 (blue) refer to the AG1® treated individuals after the experimental period, and 46 through 60 refer to PL-treated individuals after the experimental period.
Figure 4.
Figure 4.
Results from the taxonomic LEfSe analysis for the AG1 treated group.
Figure 5.
Figure 5.
Results from the taxonomic LEfSe analysis for the placebo (PL) treated group.
Figure 6.
Figure 6.
A PLS-DA ordination visualizes the effects of AG1® and placebo (PL) treated groups on community functional heterogeneity following four weeks of supplementation. Numbers 1 through 15 (orange) refer to the AG1® treated group. Numbers 16 through 30 (blue) refer to the PL-treated group.
Figure 7.
Figure 7.
Results from the functional LEfSe analysis for the placebo (PL) treated group.
Figure 8.
Figure 8.
Raw data for stool consistency and bowel frequency from VAS, and their respective deltas before and after supplementation. Data are shown as Mean + SD.
Figure 9.
Figure 9.
Raw data for the Digestion-associated Quality of Life Questionnaire (DQLQ) and Bristol stool scale and their respective deltas before and after supplementation. Data are shown as Mean + SD.
See this image and copyright information in PMC

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