Characterization of the Gut Microbiota Metagenomic Signature According to Physical Fitness and Its Implications for Intestinal Health.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Gut microbiota composition (α-diversity)
研究概览
简要总结
The gut microbiota comprises all microorganisms inhabiting the digestive tract, evolving throughout life under the influence of various intrinsic and extrinsic factors. Under healthy conditions, the microbiota remains stable, resilient, and maintains a symbiotic relationship with its host. Conversely, dysbiosis refers to an alteration in microbial composition and function, which has been linked to diseases such as inflammatory bowel disease (IBD). IBD, including Crohn's disease and ulcerative colitis, is associated with a disrupted microbiota compared to healthy individuals, leading to impaired intestinal barrier integrity and activation of local inflammatory pathways.
Increasing evidence also suggests that the gut microbiota of athletes differs from that of physically inactive individuals, showing greater microbial diversity and higher concentrations of short-chain fatty acids (SCFAs). In this context, the present clinical study aims to characterize the bacterial metagenome of the gut microbiota across a continuum ranging from inactive individuals to elite athletes with high or very high energy demands. The ultimate goal of this project is to determine whether specific gut microbiota composition and functional profiles are associated with different levels of exercise capacity, and to create a fecal microbiota biobank for future research on intestinal health.
详细描述
The gut microbiota includes all microorganisms-bacteria, viruses, and fungi-that inhabit the digestive tract. Colonization begins at birth and evolves throughout life under the influence of numerous factors such as diet, antibiotic use, sleep, stress, physical activity, exposure to environmental agents, as well as age, sex, and ethnic or migratory background.
This microbial ecosystem performs several essential functions for its host, including digestion and nutrient absorption, immune regulation, and protection against pathogens. Through the fermentation of complex carbohydrates, particularly dietary fibers indigestible by human enzymes, certain bacteria produce short-chain fatty acids (SCFAs), mainly butyrate, propionate, and acetate. These metabolites play a key role in maintaining intestinal barrier integrity and in the energy metabolism of colonocytes.
When microbial composition or function is altered, whether in diversity, relative proportions, or metabolic pathways, a state of dysbiosis occurs. This imbalance is frequently observed in various pathological conditions and has been associated with the development of diseases such as diabetes, certain cancers, atherosclerosis, asthma, inflammatory bowel diseases (IBD), and even depression.
IBD encompasses Crohn's disease (CD) and ulcerative colitis (UC). While CD is characterized by discontinuous lesions throughout the gastrointestinal tract, UC involves continuous and superficial inflammation of the colon. These pathologies affect 0.3-0.5% of the global population. Numerous studies have demonstrated significant differences in microbiota composition between IBD patients and healthy individuals, leading to impaired intestinal barrier function.
In parallel, a growing body of evidence suggests that the gut microbiota of physically active individuals differs from that of sedentary people.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participant
- •Aged between 18 and 30 years (inclusive)
- •Body Mass Index (BMI) between 18 and 25 kg/m² (inclusive)
- •No history of gastrointestinal disease, including inflammatory bowel disease
- •Be a non-smoker.
- •Have a regular bowel transit (1-2 bowel movements per day or every other day) without recurrent episodes of diarrhea or constipation
- •Having provided free, informed, and written consent to participate in the study
- •Training status :
- •Low to moderate active subjects : Perform 2 to 4 hours per week of moderate to vigorous physical activity (VO₂max between 40 and 50 mL·min-¹·kg-¹).
- •Trained subjects : Perform 5 to 7 hours per week of regular endurance training for at least one year (VO₂max between 50 and 65 mL·min-¹·kg-¹).
- •Highly trained subjects : Perform at least 10 hours per week of structured endurance training, with daily or twice-daily sessions (VO₂max greater than 65 mL·min-¹·kg-¹).
排除标准
- •History of cardiovascular disease.
- •Presence of a metabolic disorder (e.g., diabetes).
- •Use of antibiotics, antifungal, or antiparasitic agents within the past 3 months, or planned use during participation in the study.
- •Use of prebiotic and/or probiotic supplements within the 7 days preceding the study, providing ≥10⁸ CFU or organisms per day.
- •Current use of medication for chronic pain management, including paracetamol, vasodilators, homeopathic treatments, or aspirin at doses >500 mg/day.
- •Simultaneous participation in another clinical study involving human subjects, or recent participation in a previous study for which the exclusion period has not yet expired.
研究组 & 干预措施
Trained subjects
V̇O₂max : 50-65 ml/min/kg
干预措施: Submaximal exercise test (Diagnostic Test)
Low to moderate active subjects
V̇O₂max : 40-50 ml/min/kg
干预措施: Maximal incremental exercise test (Diagnostic Test)
Low to moderate active subjects
V̇O₂max : 40-50 ml/min/kg
干预措施: Submaximal exercise test (Diagnostic Test)
Low to moderate active subjects
V̇O₂max : 40-50 ml/min/kg
干预措施: Fecal sampling (Biological)
Trained subjects
V̇O₂max : 50-65 ml/min/kg
干预措施: Maximal incremental exercise test (Diagnostic Test)
Trained subjects
V̇O₂max : 50-65 ml/min/kg
干预措施: Fecal sampling (Biological)
Highly trained subjects
V̇O₂max > 65 ml/min/kg
干预措施: Maximal incremental exercise test (Diagnostic Test)
Highly trained subjects
V̇O₂max > 65 ml/min/kg
干预措施: Submaximal exercise test (Diagnostic Test)
Highly trained subjects
V̇O₂max > 65 ml/min/kg
干预措施: Fecal sampling (Biological)
结局指标
主要结局
Gut microbiota composition (α-diversity)
时间窗: Week 1
The primary outcome measure will be α-diversity (i.e., Shannon index) assessed from fecal samples collected from each participant. This index will serve as the main criterion to detect gut microbiota remodeling associated with training status and key parameters of aerobic performance. After transforming the continuous quantitative variables into discrete variables according to standardized performance scales, we will evaluate whether statistical differences exist in α-diversity between the defined groups using comparative statistical analyses (parametric or non-parametric depending on data distribution). This approach aims to identify associations between gut microbial biodiversity, training status, and aerobic performance, with the broader goal of exploring microbial signatures potentially beneficial to intestinal health.
次要结局
- β-diversity (i.e., differences between samples)(Week 1)
- Establish a fecal biobank(Week 1)
研究者
Frédéric Derbré
Associate Professor
University of Rennes 2