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.

NCT03864107 | Unknown

• 1 other identifier: R18-P206
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Metabolic Syndrome; Insulin Resistance

Keywords

Glycaemic Control; Gut Permeability; Gut Microbiota; Metabolic Endotoxemia; Metabolic Health

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (18)

• 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 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)

• 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)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women living in and around Loughborough, Leicestershire, United Kingdom

You may qualify if:

• 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)

Sponsors & Collaborators

• Loughborough University: lead
• University of Reading: collaborator

Study Sites (1)

School of Sport, Exercise and Health Sciences

Loughborough, Leicestershire, LE11 3TU, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood plasma/ serum, urine, faeces, peripheral blood mononuclear cells

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Carl Hulston, PhD

  Loughborough University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl Hulston, PhD

CONTACT

+44 (0)1509 226449; c.j.hulston@lboro.ac.uk

Malvina Begalli, MSc

CONTACT

M.Begalli@lboro.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer Nutrition and Metabolism

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: March 6, 2019
• Study Start: March 21, 2019
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

GB (1)