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临床试验/NCT03344133
NCT03344133Unknown不适用

Effect of a 4-week Moderate Intensity Exercise Programme on Gut Microbiota, Cardiovascular Disease Risk Factors and Appetite Regulation in Overweight Women

University of Glasgow1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年9月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Gut microbiota composition

研究概览

简要总结

Evidence suggests that gut microbiota contributes to the development of atherosclerosis and therefore CVDs. Exercise has been extensively reported to be protective against CVDs due to modification of body fatness, metabolic risk factors and cardio-respiratory fitness. It remains unclear whether impact of exercise on CVD risk can be at least in part explained by changes in the microbiota. It also remains to be investigated whether modification of appetite and appetite hormones due to participation in exercise are related to changes in the gut microbiota composition. Therefore, this study will be conducted in overweight, healthy, sedentary women and will investigate the effect of a 4-week moderate intensity exercise programme on gut microbiota composition and metabolic activity, plasma concentrations of fasting and postprandial lipids, glucose, insulin and inflammatory markers, fasting and postprandial gut appetite hormones, subjective appetite measures and cardio-respiratory fitness.

详细描述

Study Design: This is a randomized controlled study with a parallel design. Healthy, sedentary females aged between 18-45 years old will be recruited by means of an advertisement leaflet and word of mouth. Eligible participants will be enrolled in the study and will be randomly allocated to either exercise intervention (EX) or control (C) groups. The EX group will participate in a 4-week exercise intervention and the C group will be asked to continue with habitual life style for 4 weeks. Before and after 4 weeks of the intervention, participants from both groups will be asked to conduct a submaximal exercise test and a 7-hour experimental trial during which blood samples will be collected and metabolic rate will measured before and after consumption of standardized breakfast and lunch. Prior to the first 7-hour trial, participants will be asked to record diet for 3 days and replicate this diet prior to the second 7-hour trial. During these 3 days participants will provide fresh stool samples. Participants allocated to control group will have the option to participate in exercise intervention. A subset of the participants will repeat a 7-hour experimental trial and provide fresh stool and urine sample after 7 days of detraining.

Methods:

Preliminary Health Check: Participants will undertake a health screening questionnaire on the day of recruitment. Participants will also need to fill in Physical Activity Readiness Questionnaire (PARQ). Only participants who answered "no" to all questions in PARQ will conduct the submaximal exercise test.

Anthropometry: All participants will have height, weight and waist circumference measured at baseline and 4 weeks after the intervention.

7-hour Experimental Trial: Participants will attend the metabolic suite (New Lister Building, Glasgow Royal infirmary) in a fasted state at approximately 9.00 am. Participants will be instructed to lie supine on the couch, with the head resting on the pillow provided. Resting metabolic rate will be measured for 20 minutes and fasting blood sample will be obtained. A breakfast meal will be consumed immediately after the fasting sample and a lunch meal after 4 hours. Blood samples will be taken throughout a cannula hourly after breakfast and lunch consumption. Following each blood sample, metabolic rate will be measured for the duration of 20 minutes. Prior each blood sample, participants will fill in appetite questionnaires. Blood samples will be analysed for plasma lipids, glucose, insulin, inflammatory markers and gut appetite hormones using standard existing procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Healthy, sedentary females, BMI>25 kg/m2, on a stable body weight for the last 3 months

排除标准

  • •Acute or chronic illness, use of antibiotics the past 3 months, smoking

研究组 & 干预措施

Control

No Intervention

4 weeks of habitual life style

Exercise

Experimental

4-week moderate intensity exercise programme

干预措施: Exercise (Behavioral)

结局指标

主要结局

Gut microbiota composition

时间窗: 12 months

Changes in the gut microbiota composition measured by 16S rRNA amplicon sequencing.

次要结局

  • Peptide YY (PYY)(12 months)
  • Glucagon-like peptide-1 (GLP-1)(12 months)
  • Subjective appetite(12 months)
  • Faecal short-chain fatty acids(12 months)
  • Faecal pH(1 month)
  • Body weight(1 month)
  • Height(1 month)
  • Body fat (kilograms)(1 month)
  • Interleukin-6 (IL-6)(3 months)
  • Glucose(3 months)
  • Triglycerides(3 months)
  • Insulin(3 months)
  • Body fat (% percentage)(1 month)
  • Body Mass Index (BMI)(1 month)
  • Maximum Oxygen Consumption(2 weeks)
  • Energy substrate oxidation(6 months)
  • Resting Metabolic Rate(2 month)
  • Dietary Intake(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Konstantinos Gerasimidis

Senior Lecturer

University of Glasgow

研究点 (1)

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