Clinical trial NCT03864107: 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Metabolic Syndrome
Insulin Resistance
Keywords: Glycaemic Control
Gut Permeability
Gut Microbiota
Metabolic Endotoxemia
Metabolic Health
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: University of Reading
First posted: 2019-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women living in and around Loughborough, Leicestershire, United Kingdom

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Primary outcomes:
measure: Glycaemic control / Whole body insulin sensitivity index
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Systemic Markers of Metabolic Endotoxemia (for example LBP determined using an ELISA)
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary outcomes:
measure: Gut permeability
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Anthropometric Measurements (for example height and weight that will be aggregated to report BMI in kg/m^2)
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Fasting Serum Lipid Profile (for example total, HDL and LDL cholesterol, TAG, free fatty acids measured by spectrophotometric assay)
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Systemic Markers of Inflammation (for example IL-6, CRP determined using an ELISA/ spectrophotometric assay)
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: 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)
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Fasting hormone concentration (for example ghrelin, leptin measured by ELISA)
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Characterisation of immune cell migratory capacity using an ex vivo model (in a sub-cohort of obese participants only)
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Characterisation of immune cell populations (monocyte subsets) from peripheral blood mononuclear cells
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Dietary intake
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Fasting blood pressure
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Fasting arterial stiffness
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Step count
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Self-reported activity
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Sleeping pattern
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Functional tests
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Questionnaires
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Urinary metabolomics
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
measure: Microbiome analysis
timeFrame: Cross-sectional (all outcome measures will be collected within a 4 week period)
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: School of Sport, Exercise and Health Sciences
state: Leicestershire
Study officials:
affiliation: Loughborough University
name: Carl Hulston, PhD
role: PRINCIPAL_INVESTIGATOR
References: