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

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.

Acute Effects of Naturally Occurring Guayusa Tea and Nordic Lion's Mane Extracts on Cognitive Performance.

The aim of this study was to assess the effects of guayusa extract and Nordic Lion's Mane (LM) on cognition. Using a randomized, double-blind, placebo-controlled, crossover design, we examined the effects of a single dose of 650 mg guayusa extract (AMT: AmaTea® Max) vs. 1 g Nordic-grown Lion's Mane (LM) vs. placebo (PL). Participants attended three testing visits consisting of neuropsychological tests (Go/No-go, N-Back, and Serial 7 s tasks) assessing performance, subjective assessments of cognitive perception, and vital signs. Each assessment was measured at baseline (pre-ingestion) and 1 and 2 h post ingestion. AMT significantly (p ≤ 0.05) improved the number of attempts during Serial 7s, total score, number of correct responses, total number of responses, and reaction time during N-Back and improved Go stimulus reaction time, but it reduced the percentage of correct responses in the No-go stimulus response during Go/No-go. LM significantly (p ≤ 0.05) improved the number of attempts during Serial 7s and reaction time during N-Back and improved Go stimulus reaction time in Go/No-go. AMT improved mental clarity, focus, concentration, mood, and productivity at 1 and 2 h (p < 0.05); the ability to tolerate stress at 1 h; and had greater ratings than LM and PL for mental clarity, focus, concentration, and productivity. PL improved focus and concentration at 1 h from baseline (p ≤ 0.05). AMT and LM improved subjective ratings of "happiness compared to peers" and "getting the most out of everything" (p < 0.05); however, this occurred earlier in LM (i.e., 1 h post ingestion). AMT uniquely elevated blood pressure from baseline. AMT significantly improved cognitive performance and self-perceived cognitive indices of affect over a 2 h period and perceptions of happiness 2 h post ingestion. In comparison, LM helped improve working memory, complex attention, and reaction time 2 h post ingestion and perceptions of happiness over a 2 h period.

Methylliberine Ingestion Improves Various Indices of Affect but Not Cognitive Function in Healthy Men and Women.

This study assessed the acute effects of oral methylliberine (DynamineTM) supplementation on cognitive function and indices of well-being. This was a double-blind, randomized, within-subject crossover trial. In total, 25 healthy men and women (33.5 ± 10.7 yr, 172.7 ± 8.6 cm, 73.3 ± 11.0 kg) underwent pretesting before ingesting methylliberine (100 mg) or a placebo (PLA) for 3 days. On the fourth day, the participants were tested before their fourth dose (baseline) and every hour post-ingestion for 3 h. After a one-week washout period, the participants repeated testing with the alternate investigational product. The testing battery consisted of vitals, Stroop test, Trail Making Test-B, and visual analog scales that assessed various indices of well-being. Mixed factorial ANOVAs with repeated measures were used to assess all variables. There were significant (p ≤ 0.050) interactions in terms of concentration, motivation, and mood. Methylliberine improved concentration at 1 and 3 h, motivation at 3 h, and mood at 1, 2, and 3 h (p ≤ 0.050). Methylliberine improved energy, sustained energy, and mood in all participants to a greater extent than PLA at 1 h and 3 h relative to baseline (p ≤ 0.050). PLA improved motivation at 1 and 2 h and mood at 2 h (p ≤ 0.050). Methylliberine improved concentration, well-being, and the ability to tolerate stress to a greater extent than PLA at 3 h relative to baseline (p ≤ 0.050). Women observed elevations in sustained energy at 1 and 3 h (p ≤ 0.050) with methylliberine vs. PLA. Methylliberine had a negligible influence on cognitive function and vitals (p > 0.050), and no adverse events were reported. Methylliberine significantly improved subjective feelings of energy, concentration, motivation, and mood, but not cognitive function. PLA improved motivation and mood at hours 1 and 2, while methylliberine sustained these benefits for longer. Methylliberine also improved concentration, well-being, and the ability to tolerate stress to a greater degree than PLA, while having no detrimental effects on vital signs. Methylliberine also seemed to have a positive impact on sustained energy in women.