Investigating the Possible Link Between Habitual Diet, Physical Activity, Sleeping Patterns, Obesity Status and Age With Gut Bacterial Composition, Gut Barrier Function, Metabolic Endotoxemia, Systemic Inflammation and Glycaemic Control.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Systemic Markers of Metabolic Endotoxemia (for example LBP determined using an ELISA)
研究概览
简要总结
In the UK, 25% of the adults are affected by metabolic syndrome (NHS, 2016). Metabolic syndrome is a cluster of different conditions including: hyperglycaemia, insulin resistance hypertriglyceridemia, dyslipidaemia and hypertension. Such individuals also have increased risk of developing type 2 diabetes and cardiovascular disease. The factors contributing to the development of metabolic syndrome are potentially numerous and understudied in humans, with much of what we think we know coming from animal research. Recent animal studies have pointed towards gut health playing a role in metabolic health. More specifically it has been suggested that changes in the composition of the gut microbiota may drive insulin resistance and type 2 diabetes through a mechanism that is linked to increased gut permeability and the development of metabolic endotoxemia and inflammation. Yet, this link has not been confirmed in humans. This research will look at the relationship between diet, physical activity, sleeping patterns, obesity status and age etc. and measures of gut bacterial composition, gut barrier function and metabolic health. Findings will provide us with new insights on the effect of different physiological and behavioural/ lifestyle variables on gut health and metabolic function.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18-70 years
- •BMI 18.5-50 kg/m2
- •Not taking antibiotics and antimicrobial drugs for at least three months
- •Both physically active and sedentary individuals will be eligible to take part in the study
- •Weight stable (±5kg) for at least 6 months
- •Excusion Criteria:
- •No cardiometabolic (e.g. heart disease, high blood pressure) or inflammatory illness
- •Smokers (including the use of vaporisers and e-cigarettes)
- •Taking anti-inflammatory drugs (excluding aspirin)
排除标准
- 未提供
结局指标
主要结局
Systemic Markers of Metabolic Endotoxemia (for example LBP determined using an ELISA)
时间窗: Cross-sectional (all outcome measures will be collected within a 4 week period)
Assessed following the collection of fasted blood samples
Glycaemic control / Whole body insulin sensitivity index
时间窗: Cross-sectional (all outcome measures will be collected within a 4 week period)
Assessed by oral glucose tolerance test
次要结局
- Fasting hormone concentration (for example ghrelin, leptin measured by ELISA)(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Step count(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Self-reported activity(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Systemic Markers of Inflammation (for example IL-6, CRP determined using an ELISA/ spectrophotometric assay)(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Characterisation of immune cell migratory capacity using an ex vivo model (in a sub-cohort of obese participants only)(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Characterisation of immune cell populations (monocyte subsets) from peripheral blood mononuclear cells(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Dietary intake(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Functional tests(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Gut permeability(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Anthropometric Measurements (for example height and weight that will be aggregated to report BMI in kg/m^2)(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Fasting Serum Lipid Profile (for example total, HDL and LDL cholesterol, TAG, free fatty acids measured by spectrophotometric assay)(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Systemic Markers of Oxidative Stress (for example protein carbonyls, glutathione and redox enzymes by ELISA/ spectrophotometric assay (in sub-cohort of participants not taking high-dose antioxidant supplements)(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Urinary metabolomics(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Fasting blood pressure(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Fasting arterial stiffness(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Sleeping pattern(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Questionnaires(Cross-sectional (all outcome measures will be collected within a 4 week period))
- Microbiome analysis(Cross-sectional (all outcome measures will be collected within a 4 week period))
研究者
Carl Hulston
Senior Lecturer Nutrition and Metabolism
Loughborough University