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

IF 4.5 2区 医学 Q1 NUTRITION & DIETETICS Journal of the International Society of Sports Nutrition Pub Date : 2024-12-01 Epub Date: 2024-10-01 DOI:10.1080/15502783.2024.2409682
Michael B La Monica, Betsy Raub, Shelley Hartshorn, Ashley L Gustat, Jodi Grdic, Trevor O Kirby, Jeremy R Townsend, Jen Sandrock, Tim N Ziegenfuss
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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.

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补充 AG1® 对健康成年人肠道微生物群的影响:随机、双盲、安慰剂对照临床试验。
背景:本研究旨在检测市售多成分粉末(AG1Ⓡ)对肠道微生物组的影响,并评估 AG1Ⓡ 对健康男性和女性的胃肠道耐受性和其他临床安全性指标的影响:采用双盲、随机、双臂、安慰剂对照、平行设计,我们研究了为期 4 周的 AG1Ⓡ 与安慰剂 (PL) 每日补充方案。15 名男性和 15 名女性提供了用于微生物组分析的粪便样本、消化系统生活质量问卷 (DQLQ),并在 4 周干预前后完成了视觉模拟量表 (VAS) 和布里斯托尔粪便图表,以评估粪便稠度和排便频率。在 4 周干预前后,还对参与者的血液检查(全血细胞计数、全血细胞计数和血脂组合)进行了评估。α多样性由香农和Chao1指数评分确定,并通过双向方差分析进行评估;分类丰度和功能通路的β多样性通过偏最小二乘判别分析进行可视化,并通过PERMANOVA进行统计评估。为确定关键生物标记物,通过线性判别分析(LDA)效应大小(LEfSe)分析了分类学相对丰度和归一化功能通路计数的特定特征差异。问卷调查、临床安全指标和血液动力学采用重复测量混合因子方差分析进行评估。本研究已在 clinicaltrials.gov (NCT06181214) 上注册:结果:AG1Ⓡ补充剂富集了两个益生菌类群(嗜酸乳杆菌和双歧杆菌),这可能源于产品中存在的益生菌物种,还富集了乳酸杆菌CH_LC01和醋酸菌sp900066565 ASM1486575v1,同时减少了梭状芽孢杆菌sp000435835。在群落功能方面,AG1Ⓡ富集了两条功能途径,同时没有减少任何途径。另外,PL富集了六条功能途径,但减少了五条。两种治疗方法都没有对通过 DQLQ 得出的消化系统生活质量、通过 VAS 得出的排便频率或通过 VAS 和布里斯托尔得出的粪便稠度产生负面影响。然而,在补充 AG1Ⓡ四周后,DQLQ 得分可能有了更大的提高(+62.5%,p = 0.058,d = 0.73),而 PL 则下降了(-50%)。此外,AG1Ⓡ在补充后不会明显改变临床安全指标,这为其安全性提供了证据:AG1Ⓡ可供健康成年人在四周内安全食用,并可能对他们的消化症状生活质量产生有益影响。
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来源期刊
Journal of the International Society of Sports Nutrition
Journal of the International Society of Sports Nutrition NUTRITION & DIETETICS-SPORT SCIENCES
CiteScore
8.80
自引率
3.90%
发文量
34
审稿时长
6-12 weeks
期刊介绍: Journal of the International Society of Sports Nutrition (JISSN) focuses on the acute and chronic effects of sports nutrition and supplementation strategies on body composition, physical performance and metabolism. JISSN is aimed at researchers and sport enthusiasts focused on delivering knowledge on exercise and nutrition on health, disease, rehabilitation, training, and performance. The journal provides a platform on which readers can determine nutritional strategies that may enhance exercise and/or training adaptations leading to improved health and performance.
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