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.

Obesity Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03864107
• Other study ID #: R18-P206
• Status: Recruiting
• Start date: March 21, 2019
• Est. completion date: March 2022

Study information

• Verified date: February 2021
• Source: Loughborough University
• Contact: Carl Hulston, PhD
• Phone: +44 (0)1509 226449
• Email: c.j.hulston[@]lboro.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endotoxemia
• Inflammation
• Insulin Resistance
• Metabolic Syndrome
• Obesity

Locations

Country	Name	City	State
United Kingdom	School of Sport, Exercise and Health Sciences	Loughborough	Leicestershire

Sponsors (2)

Lead Sponsor	Collaborator
Loughborough University	University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycaemic control / Whole body insulin sensitivity index	Assessed by oral glucose tolerance test	Cross-sectional (all outcome measures will be collected within a 4 week period)
Primary	Systemic Markers of Metabolic Endotoxemia (for example LBP determined using an ELISA)	Assessed following the collection of fasted blood samples	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Gut permeability	Urine samples will be used to assess the ratio of lactulose to mannitol excretion	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Anthropometric Measurements (for example height and weight that will be aggregated to report BMI in kg/m^2)	Measured using standard equipment	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Fasting Serum Lipid Profile (for example total, HDL and LDL cholesterol, TAG, free fatty acids measured by spectrophotometric assay)	Assessed following the collection of fasted blood samples	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Systemic Markers of Inflammation (for example IL-6, CRP determined using an ELISA/ spectrophotometric assay)	Assessed following the collection of fasted blood samples	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	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)	Assessed following the collection of fasted blood samples	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Fasting hormone concentration (for example ghrelin, leptin measured by ELISA)	Assessed following the collection of fasted blood samples	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Characterisation of immune cell migratory capacity using an ex vivo model (in a sub-cohort of obese participants only)	Assessed following the collection of fasted blood samples by flow cytometry analysis	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Characterisation of immune cell populations (monocyte subsets) from peripheral blood mononuclear cells	Assessed following the collection of fasted blood samples by flow cytometry analysis	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Dietary intake	Assessed via a Food Frequency Questionnaire (FFQ)	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Fasting blood pressure	Systolic and diastolic blood pressure and central blood pressure, measured in triplicate using a Mobil-O-Graph following 20 min period of seated rest	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Fasting arterial stiffness	Pulse wave analysis and velocity, measured in triplicate using a Mobil-O-Graph following 20 min period of seated rest	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Step count	Habitual daily step count as measured by pedometer for 7 consecutive days prior to the first experimental session	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Self-reported activity	Participants will complete the International Physical Activity Questionnaire to measure participants' time spent in physical activity.	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Sleeping pattern	Habitual sleep pattern will be assessed by sleep diary 7 consecutive days prior to the first experimental session	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Functional tests	To be assessed by handgrip strength (measured in force) and timed sit-to-stand movements (measured as time in seconds to perform 5 sit-to-stand movements followed by the maximum number of movements that can be completed in 60 seconds)	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Questionnaires	Morningness and Eveningness questionnaire; Mood state	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Urinary metabolomics	Urine samples will be used for metabolic profiling of excreted metabolites	Cross-sectional (all outcome measures will be collected within a 4 week period)
Secondary	Microbiome analysis	Faecal samples will be used to analyse gut microbiota composition through the 16S ribosomal RNA gene sequencing technique	Cross-sectional (all outcome measures will be collected within a 4 week period)