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临床试验/NCT07499960
NCT07499960已完成不适用

Impact of Short-term Apple Intake on the Human Faecal Metabolome Assessed by 1H NMR Spectroscopy

Czech University of Life Sciences Prague1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Change from baseline in faecal metabolomic profile assessed by ¹H NMR spectroscopy

研究概览

简要总结

This pilot dietary intervention study aimed to investigate whether short-term consumption of apples influences the human faecal metabolomic profile. Apples are a commonly consumed source of dietary fibre, particularly pectin, which undergoes microbial fermentation in the colon and may lead to measurable metabolic changes. Healthy adult volunteers were instructed to consume three apples per day for three consecutive days under free-living conditions. Faecal samples were collected before and after the intervention and analysed using proton nuclear magnetic resonance (¹H NMR) spectroscopy to assess changes in metabolite concentrations. The study sought to explore whether metabolomic profiling can detect functional microbial responses to increased fruit intake and provide preliminary insight into the metabolic impact of short-term dietary fibre exposure.

详细描述

This study was designed as a single-arm exploratory dietary intervention to evaluate short-term metabolic responses to increased intake of fruit-derived dietary fibre. Participants were instructed to consume three fresh Gala apples per day for three consecutive days while otherwise maintaining their habitual diet and lifestyle. The intervention was conducted under free-living conditions to reflect realistic dietary behaviour.

Faecal samples were collected immediately before the intervention and after completion of the three-day exposure period. Samples were processed using standardized laboratory protocols to obtain aqueous extracts suitable for metabolomic analysis. Proton nuclear magnetic resonance (¹H NMR) spectroscopy was employed to generate quantitative metabolic profiles, enabling detection of metabolites associated with microbial fermentation and host-microbe metabolic interactions.

Metabolite concentrations were quantified using targeted profiling approaches, and both multivariate and univariate statistical analyses were applied to assess intervention-related changes in the faecal metabolome. The study was intended to provide mechanistic insight into how short-term consumption of a commonly consumed fruit may influence gut microbial metabolic activity, and to evaluate the feasibility of metabolomics-based assessment of dietary exposures in small-scale human intervention studies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

盲法说明

Due to the nature of the dietary intervention, neither participants nor investigators were blinded to the intervention. All participants received the same exposure, and outcome assessment was based on objective metabolomic measurements.

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adults aged 18-30 years
  • Able and willing to consume apples daily during the intervention period
  • Willing to provide stool samples before and after the intervention
  • Not following a specific prescribed diet
  • Physically able to maintain usual daily activities during the study
  • Able to provide written informed consent

排除标准

  • Diagnosed gastrointestinal, metabolic, or chronic systemic disease
  • Use of antibiotics, probiotics, or regular medication affecting digestion in the period prior to enrolment
  • Known allergy or intolerance to apples or other fruits
  • Current participation in another dietary or clinical study
  • Following a medically prescribed or restrictive diet
  • Pregnancy or breastfeeding

结局指标

主要结局

Change from baseline in faecal metabolomic profile assessed by ¹H NMR spectroscopy

时间窗: Baseline and immediately after completion of the 3-day dietary intervention

The outcome measure represents the change in concentrations of detected faecal metabolites between pre- and post-intervention samples, reflecting potential alterations in gut microbial metabolic activity associated with increased fruit intake.

次要结局

未报告次要终点

研究者

发起方
Czech University of Life Sciences Prague
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaroslav Havlik

Associate Professor

Czech University of Life Sciences Prague

研究点 (1)

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