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The exercise and gut bacteria study

Determining the effect of exercise on the gut microbiota of obese men: A pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN91278516
Enrollment
19
Registered
2016-11-30
Start date
2015-07-22
Completion date
Unknown
Last updated
2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Nutritional, Metabolic, Endocrine Obesity

Interventions

The participants will need to visit the Leicester Diabetes Centre for three study visits (pre-, post- and maintenance), and attend the gym within the centre three times a week, for eight weeks. Pre-i
walking and/or jogging exercise will be encouraged on the treadmill to promote weight bearing exercise and increased gut transit time. All exercise sessions will be specific to the individual’s abilit

Sponsors

University of Leicester
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Caucasian Males 2. Aged 25-50 years inclusive 3. BMI 30-40kg/m2 inclusive 4. HbA1c less than 6.5% 5. Completion of an eligibility stress test and approval from an in house clinician according to our standard operating procedures 6. Able to speak and understand English

Exclusion criteria

Exclusion criteria: 1. Unable to understand and speak English 2. Unable to provide written informed consent 3. Diagnosed with type 1 or 2 diabetes 4. Diagnosed with crohn’s disease, celiac disease or irritable bowel syndrome 5. Highly active individuals or individuals meeting current physical activity guidelines (self­report =2.5 hours per week) Participants should not report exercising two or more times per week for 20minutes or longer over the past six months 6. Patients with orthopaedic limitations, motor neurone disease, stage II hypertension (systolic BP>160 and/or diastolic  BP>100mmHg), cardiovascular disease (coronary artery disease, cardiomyopathy, heart failure, cor pulmonale,  cardiac dysrhythmias, endocarditis, myocarditis, valvular heart disease, cerebrovascular disease, peripheral arterial  disease, congenital heart disease and rheumatic heart disease), pulmonary disease (inflammatory lung disease,  obstructive lung disease, chronic obstructive pulmonary disease, emphysema, cystic fibrosis, respiratory tract  infections, pleural cavity disease, pulmonary vascular disease) renal disease or chair bound 7. Current smokers 8. Are currently on a calorie restricted/weight loss diet 9. Have changed their dietary habits in the past three months 10. Individuals who have used antibiotics or pre/probitoics in the past three months 11. Weight limit (due to operating scales): maximum 200kgs

Design outcomes

Primary

MeasureTime frame
Ratio between bacteroidetes and firmicutes is measured using established qPCR assays on faecal samples collected at baseline and 8 weeks.

Secondary

MeasureTime frame
1. Relationship between gut microbiota and inflammation is investigated by measuring inflammatory markers such as CRP, TNF-a and IL-6 on non-fasting blood samples collected at baseline and 8 weeks 2. Concentration of short chain fatty acids in faecal samples is measured using established qPCR assays at baseline and 8 weeks 3. Association between the gut microbiota and physical fitness on appetite hormones is determined by measuring GLP-1, PYY and ghrelin on fasting blood samples collected at baseline and 8 weeks

Countries

United Kingdom

Contacts

Public ContactTatiana Plekhanova
Tp150@le.ac.uk+44 116 258 8571

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026