Effects of one month of intermittent fasting on the blood microbiome in healthy volunteers (OMIF): A randomized controlled crossover study protocol

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-06-15 DOI:10.1016/j.cct.2025.107986

Junhong Su , Bettina E. Hansen , Zhongren Ma , Maikel P. Peppelenbosch

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引用次数: 0

Abstract

Background

It is hypothesized that the presence of microorganisms in the gut is reflected in circulating blood through small DNA fragments resulting from the degradation of these organisms. Cross-sectional studies have not yet provided a definitive answer regarding the validity of this hypothesis, and the potential presence of a so-called common blood-microbiome remains highly controversial. Both bioinformatical pipelines (which may produce false-positive results) and environmental contamination may obscure the less than 5 % microbial DNA that is postulated to be present within the total blood DNA.

Method/design

This study aims to validate the existence of the blood microbiome using one month of intermittent fasting (OMIF). Through a prospective, randomized, controlled cross-over trial, we will evaluate the effect of OMIF on the composition and function of the blood microbiome in healthy volunteers, with secondary outcomes on clarifying the relationship between the gut and blood microbiome. Healthy volunteers aged 18–65 will be enrolled. All volunteers will undergo OMIF, a washout period and an ad libitum diet for another month, with the order of the interventions assigned randomly. We will assess the dynamics in blood microbiome in response to OMIF versus those seen during an ad libitum diet, using shotgun sequencing. Physiological changes will be monitored A dietary recall interview will be conducted during the trial to evaluate energy intake, and movement data collected from Health App will be used to assess changes in physical activity.

Conclusion

If successful, this trial provides a proof-of-concept study documenting the existence of a bona fide blood microbiome.

Clinical Trial Registration: NCT06678516

查看原文本刊更多论文

一个月间歇性禁食对健康志愿者血液微生物组的影响（OMIF）：一项随机对照交叉研究方案。

背景：假设肠道中微生物的存在通过这些微生物降解产生的小DNA片段反映在循环血液中。横断面研究尚未就这一假设的有效性提供明确的答案，所谓的共同血液微生物组的潜在存在仍然存在高度争议。生物信息管道（可能产生假阳性结果）和环境污染都可能使假定存在于全部血液DNA中的小于5% %的微生物DNA模糊不清。方法/设计：本研究旨在通过一个月的间歇性禁食（OMIF）来验证血液微生物组的存在。通过一项前瞻性、随机、对照交叉试验，我们将评估OMIF对健康志愿者血液微生物组组成和功能的影响，次要结局是澄清肠道和血液微生物组之间的关系。将招募年龄在18-65岁之间的健康志愿者。所有志愿者都将经历一个月的OMIF、一个洗脱期和自由饮食，干预的顺序是随机分配的。我们将使用霰弹枪测序来评估血液微生物组对OMIF的反应与随意饮食期间观察到的动态。在试验期间，将进行饮食回忆访谈来评估能量摄入，并使用Health App收集的运动数据来评估身体活动的变化。结论：如果成功，这项试验提供了一个概念验证研究，证明了真正的血液微生物组的存在。临床试验注册：NCT06678516。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.