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褐藻多糖补充安全,且与随机先导试验中固有免疫表型、生化参数及肠道微生物组的探索性调节相关

英文原题:Ascophyllan Supplementation Is Safe and Associated with Exploratory Modulation of Innate Immune Phenotypes, Biochemical Parameters, and the Gut Microbiome in a Randomized Pilot Trial.

查看英文原题

Ascophyllan Supplementation Is Safe and Associated with Exploratory Modulation of Innate Immune Phenotypes, Biochemical Parameters, and the Gut Microbiome in a Randomized Pilot Trial.

PubMed 2026/06/15(内容时间) Mar Drugs Q1 · IF 5.7(JCR 2025)

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研究概要

这些初步发现表明,ascophyllan 在健康成人中安全且耐受良好,并可能与先天免疫表型的调节、微生物组组成的细微差异以及抗氧化能力的方向性变化相关。

中文摘要

褐藻硫酸化多糖ascophyllan在临床前研究中显示免疫调节和抗氧化作用,但人体临床证据仍然有限。本项随机、双盲、安慰剂对照试点试验评估健康成人每日补充ascophyllan的安全性及探索性生物学效应。

12名参与者随机分组,分别接受ascophyllan(n=6)或安慰剂(n=6),持续28天。通过不良事件报告及重复实验室检查监测安全性,检查项目包括血液学、生化指标及炎症标志物。采用连续流式细胞术分析免疫细胞群,在多个时间点测定血清总抗氧化能力,并使用16S rRNA基因测序分析肠道微生物群。所有分析均为探索性。

ascophyllan补充耐受性良好,未观察到不良事件;研究期间血液学、肾功能和生化指标稳定。探索性纵向分析提示补充期间NK细胞相关表型可能发生方向性调节,包括CD57⁺、NKp46⁺和NKG2D⁺ NK细胞表型变化;但组别×时间交互作用经多重比较校正后不再具有统计学显著性。血清抗氧化能力存在个体差异,ascophyllan组中间时间点有方向性但未达显著性的升高。探索性微生物组分析提示拟杆菌科和双歧杆菌科成员的组成可能有轻微方向性变化,但多重比较校正后无菌群分类单元仍具有统计学显著性。

这些初步结果表明,ascophyllan在健康成人中安全且耐受性良好,可能调节先天免疫表型、引起轻微微生物群组成差异并使抗氧化能力呈方向性变化。仍需开展样本量充足的更大规模临床试验,以确认这些观察并进一步研究潜在生物学和临床效应。

展开英文摘要原文

Ascophyllan, a sulfated polysaccharide extracted from brown seaweed, has shown immunomodulatory and antioxidant effects in preclinical studies, yet human clinical evidence remains scarce. This randomized, double-blind, placebo-controlled pilot trial evaluated the safety and exploratory biological effects of daily ascophyllan supplementation in healthy adults.

Twelve participants were randomized to receive either ascophyllan ( n = 6) or placebo ( n = 6) for 28 days. Safety was monitored through adverse event reporting and repeated laboratory assessments, including hematology, biochemistry, and inflammatory markers. Immune cell populations were analyzed via serial flow cytometry, serum total antioxidant capacity was measured at multiple time points, and gut microbiome composition was profiled using 16S rRNA gene sequencing. All analyses were exploratory in nature.

Ascophyllan supplementation proved well tolerated, with no adverse events observed and stable hematologic, renal, and biochemical parameters throughout the study. Exploratory longitudinal analyses suggested directional modulation of NK-cell-associated phenotypes during ascophyllan supplementation, including directional changes in CD57 + , NKp46 + , and NKG2D + NK-cell phenotypes; however, group time interaction analyses did not remain statistically significant after correction for multiple comparisons. Serum antioxidant capacity showed inter-individual variability with a directional but non-significant increase in the ascophyllan group at intermediate time points. Exploratory microbiome analyses suggested modest directional compositional differences involving members of the Bacteroidaceae and Bifidobacteriaceae families; however, no taxon remained statistically significant after correction for multiple comparisons.

These preliminary findings indicate that ascophyllan is safe and well tolerated in healthy adults and may be associated with modulation of innate immune phenotypes, subtle microbiome compositional differences, and directional changes in antioxidant capacity. Larger, adequately powered clinical trials are warranted to confirm these observations and further investigate potential biological and clinical effects.

论文信息

作者
Mizuno S、Espinoza JL、Vu LQ、Banno H、Iida Y、Shinohara S、Dac DT、Nakagami Y
单位
Division of Hematology, Department of Internal Medicine, Aichi Medical University, Nagakute 480-1195, Aichi, Japan.Japan
文献类型
随机对照试验
期刊
Marine drugs2026 Jun 15
原文标识
PubMed 42346798 · DOI 10.3390/md24060213