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ObesityNCT03864107

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.

An observational study of Obesity and Metabolic Syndrome, run by Loughborough University at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Metabolic Syndrome, Insulin Resistance
How many people
100 participants
Where
1 siteUnited Kingdom
Study dates
21 Mar 2019to Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Men and women living in and around Loughborough, Leicestershire, United Kingdom

Who may be able to join

  • 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:
Show all 9Show fewer
  • 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)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Carl Hulston, PhD contact

+44 (0)1509 226449

c.j.hulston@lboro.ac.uk

Malvina Begalli, MSc contact

M.Begalli@lboro.ac.uk

United Kingdom1 site, 1 recruiting

  • School of Sport, Exercise and Health Sciences

    Loughborough, Leicestershire, LE11 3TU

    Carl Hulston, PhD

    Recruiting

Other trials in United Kingdom

About this study

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.

Keywords
Glycaemic Control, Gut Permeability, Gut Microbiota, Metabolic Endotoxemia, Metabolic Health
Medical subject headings
Obesity, Metabolic Syndrome, Insulin Resistance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycaemic control / Whole body insulin sensitivity index

    Assessed by oral glucose tolerance test

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  2. Systemic Markers of Metabolic Endotoxemia (for example LBP determined using an ELISA)

    Assessed following the collection of fasted blood samples

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

Secondary outcomes (18)

  1. Gut permeability

    Urine samples will be used to assess the ratio of lactulose to mannitol excretion

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  2. Anthropometric Measurements (for example height and weight that will be aggregated to report BMI in kg/m^2)

    Measured using standard equipment

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  3. 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

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  4. Systemic Markers of Inflammation (for example IL-6, CRP determined using an ELISA/ spectrophotometric assay)

    Assessed following the collection of fasted blood samples

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  5. 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

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  6. Fasting hormone concentration (for example ghrelin, leptin measured by ELISA)

    Assessed following the collection of fasted blood samples

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  7. 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

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  8. Characterisation of immune cell populations (monocyte subsets) from peripheral blood mononuclear cells

    Assessed following the collection of fasted blood samples by flow cytometry analysis

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  9. Dietary intake

    Assessed via a Food Frequency Questionnaire (FFQ)

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  10. 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

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  11. Fasting arterial stiffness

    Pulse wave analysis and velocity, measured in triplicate using a Mobil-O-Graph following 20 min period of seated rest

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  12. Step count

    Habitual daily step count as measured by pedometer for 7 consecutive days prior to the first experimental session

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  13. Self-reported activity

    Participants will complete the International Physical Activity Questionnaire to measure participants' time spent in physical activity.

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  14. Sleeping pattern

    Habitual sleep pattern will be assessed by sleep diary 7 consecutive days prior to the first experimental session

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  15. 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)

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  16. Questionnaires

    Morningness and Eveningness questionnaire; Mood state

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  17. Urinary metabolomics

    Urine samples will be used for metabolic profiling of excreted metabolites

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

  18. Microbiome analysis

    Faecal samples will be used to analyse gut microbiota composition through the 16S ribosomal RNA gene sequencing technique

    Measured: Cross-sectional (all outcome measures will be collected within a 4 week period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2019
  2. Study start21 Mar 2019
  3. Primary completionMar 2022 (estimated)
  4. Study completionMar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03864107
Sponsor's protocol ID
R18-P206
Status last verified
Feb 2021
First submitted
14 Feb 2019
Last updated
24 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Metabolic Syndrome, run by Loughborough University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Carl Hulston, PhD (+44 (0)1509 226449, c.j.hulston@lboro.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycaemic control / Whole body insulin sensitivity index (time frame: Cross-sectional (all outcome measures will be collected within a 4 week period)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03864107.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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