跳至主要内容
临床试验/NCT06691100
NCT06691100招募中不适用

The Acute Effects of an Endurance Exercise Bout the Gut Microbiome and Gut-derived Metabolome in Women's Distinct Fitness and Body Mass Indexes

George Washington University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Gut Microbiome Composition

研究概览

简要总结

This study aims to elucidate the differences in the gut microbiome functional activity and metabolome in adult premenopausal women with distinctive fitness levels and BMIs (with obesity, w/o obesity). The specific aims are as follows:

  • Aim 1: To examine the effects of acute aerobic exercise at 60-70% heart rate reserve (HRRmax) for 30 minutes bout on changes in the abundance of SCFA-producing bacteria and their functional downstream metabolic activity.
  • Aim 2: To examine the effects of acute aerobic exercise at 60-70% HRRmax 30-minute bout on changes in GM-released SCFA concentrations in stool and plasmatic metabolome.

详细描述

Participants who are eligible after completing the online questionnaire will be invited to three in-person visits:

VISIT A (baseline visit)

  • Participants will receive oral and written information about the study and be allowed to ask questions.
  • Participants will sign the informed consent document.
  • Inclusion and exclusion criteria will be reviewed.
  • Demographic, health, and lifestyle data will be collected.
  • Collection of height and weight.
  • Body composition analysis via DXA scan
  • Strength test: isometric mid-thigh pull and hand-grip strength test.
  • Endurance test: A cardiovascular fitness test using a cycle ergometer will be performed.
  • Participants will be provided with a hip accelerometer and at-home stool sample collection kit, and an account will be set up using Cronometer software to track their dietary intake during the study.

At VISIT B (exercise test day), after 7 to 12 days after VISIT A, the following procedures will happen:

  • Participants will return a stool sample collected within the past 5 days.
  • 7 mL of blood draw
  • Performed a 30-minute biking exercise bout at their individually calculated 60 to 70% of the HRR.
  • 7 mL of blood draw 3 minutes after the exercise

研究设计

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

入排标准

年龄范围
21 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Biological sex: female
  • •BMI 19 to 24.99 kg/m2 or BMI 30-40 kg/m2
  • •Exercisers: Exercise at least 4 times per week for 60 minutes (a total of 240 minutes per week) on a programmed exercise training either on endurance sports (e.g., running, cycling, triathlon), strength (e.g., powerlifting), or team sports (e.g., rugby, football, soccer)
  • •Non-Exercisers: Sedentary individuals who have not reached the PA guidelines (150 minutes of moderate-intensity physical activity a week, 75 minutes of vigorous-intensity physical activity, or an equivalent combination of moderate and vigorous-intensity physical activity).

排除标准

  • •Biological sex: male
  • •BMI < 19 kg/m2 or > 40 kg/m2
  • •Currently pregnant, < 2 years postpartum, lactating
  • •Currently taking any herbal, fiber, or prebiotic supplement
  • •Current or 1-month before the study, taking oral or vaginal antibiotics
  • •Diagnosed with any gastrointestinal, endocrine, digestive, cancer, or cardiovascular disease.

研究组 & 干预措施

Intervention

Experimental

30-minute exercise bout in a cycle ergometer at 60 to 70% of the Heart Rate Reserve (HRR) and corresponding power (watts).

干预措施: Aerobic Exercise (Behavioral)

结局指标

主要结局

Gut Microbiome Composition

时间窗: Before the exercise intervention and immediately after the intervention

Shotgun metagenomics will be used to examine the abundance of specific SCFA-producing bacteria in the stool (e.g., Ruminococcus)

Gut Microbiome Function

时间窗: Before the exercise intervention and immediately after the intervention

Shotgun metagenomics will be used to examine the BGCs (i.e., the genes within the microbial genome that dictate gut microbial functionality) to investigate functional downstream metabolic activity.

Plasma Metabolome

时间窗: Before the exercise intervention, immediately after the exercise intervention, and 24 hours before the intervention

Gas chromatography and mass spectrometry will be used to measure concentrations of SCFAs in plasma before and after the exercise intervention

Stool Metabolome

时间窗: Before the exercise intervention, immediately after the exercise intervention, and 24 hours before the intervention

Gas chromatography and mass spectrometry will be used to measure concentrations of SCFAs in stool before and after the exercise intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验