Overweight and ObesityNCT03344133
Effect of Exercise Programme on Gut Microbiota, CVD Risk Factors and Appetite Regulation in Overweight Women
A study testing Exercise in people with Overweight and Obesity, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
Evidence suggests that gut microbiota contributes to the development of atherosclerosis and therefore CVDs. Exercise has been extensively reported to be protective against CVDs due to modification of body fatness, metabolic risk factors and cardio-respiratory fitness. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Sep 2015to 30 Nov 2017
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, sedentary females, BMI>25 kg/m2, on a stable body weight for the last 3 months
Who cannot join
- Acute or chronic illness, use of antibiotics the past 3 months, smoking
Trial locations and contacts
1 site in 1 country.
Eleni Rizou, BSc MSc contact
Konstantinos Gerasimidis, BSc MSc PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
School of Medicine, University of Glasgow / New Lister Building, Glasgow Royal Infirmary
Glasgow, G312ER
Eleni Rizou, BSc MSc, e.rizou.1@research.gla.ac.uk
Konstantinos Gerasimidis, BSc MSc PhD, Konstantinos.Gerasimidis@glasgow.ac.uk
About this study
Official title: Effect of a 4-week Moderate Intensity Exercise Programme on Gut Microbiota, Cardiovascular Disease Risk Factors and Appetite Regulation in Overweight Women
Evidence suggests that gut microbiota contributes to the development of atherosclerosis and therefore CVDs. Exercise has been extensively reported to be protective against CVDs due to modification of body fatness, metabolic risk factors and cardio-respiratory fitness. It remains unclear whether impact of exercise on CVD risk can be at least in part explained by changes in the microbiota. It also remains to be investigated whether modification of appetite and appetite hormones due to participation in exercise are related to changes in the gut microbiota composition. Therefore, this study will be conducted in overweight, healthy, sedentary women and will investigate the effect of a 4-week moderate intensity exercise programme on gut microbiota composition and metabolic activity, plasma concentrations of fasting and postprandial lipids, glucose, insulin and inflammatory markers, fasting and postprandial gut appetite hormones, subjective appetite measures and cardio-respiratory fitness.
Read the detailed description
Study Design: This is a randomized controlled study with a parallel design. Healthy, sedentary females aged between 18-45 years old will be recruited by means of an advertisement leaflet and word of mouth. Eligible participants will be enrolled in the study and will be randomly allocated to either exercise intervention (EX) or control (C) groups. The EX group will participate in a 4-week exercise intervention and the C group will be asked to continue with habitual life style for 4 weeks. Before and after 4 weeks of the intervention, participants from both groups will be asked to conduct a submaximal exercise test and a 7-hour experimental trial during which blood samples will be collected and metabolic rate will measured before and after consumption of standardized breakfast and lunch. Prior to the first 7-hour trial, participants will be asked to record diet for 3 days and replicate this diet prior to the second 7-hour trial. During these 3 days participants will provide fresh stool samples. Participants allocated to control group will have the option to participate in exercise intervention. A subset of the participants will repeat a 7-hour experimental trial and provide fresh stool and urine sample after 7 days of detraining.
Methods:
Preliminary Health Check: Participants will undertake a health screening questionnaire on the day of recruitment. Participants will also need to fill in Physical Activity Readiness Questionnaire (PARQ). Only participants who answered "no" to all questions in PARQ will conduct the submaximal exercise test.
Anthropometry: All participants will have height, weight and waist circumference measured at baseline and 4 weeks after the intervention.
7-hour Experimental Trial: Participants will attend the metabolic suite (New Lister Building, Glasgow Royal infirmary) in a fasted state at approximately 9.00 am. Participants will be instructed to lie supine on the couch, with the head resting on the pillow provided. Resting metabolic rate will be measured for 20 minutes and fasting blood sample will be obtained. A breakfast meal will be consumed immediately after the fasting sample and a lunch meal after 4 hours. Blood samples will be taken throughout a cannula hourly after breakfast and lunch consumption. Following each blood sample, metabolic rate will be measured for the duration of 20 minutes. Prior each blood sample, participants will fill in appetite questionnaires. Blood samples will be analysed for plasma lipids, glucose, insulin, inflammatory markers and gut appetite hormones using standard existing procedures.
Feacal sample collection \& analysis: A disposable stool sample collection kit will be provided prior to the 7-hour trial day. Once collected, the container is sealed and placed in a larger sealable bag with a reducing sachet to remove oxygen and maintain anaerobic bacteria. Stool samples will be measured for changes in gut microbiota based on 16S rRNA amplicon sequencing, bacterial functional capacity and targeted bacterial metabolites (short chain fatty acids, sulphide, ammonia).
Exercise Training Programme: Exercise training will consist of 4 weekly sessions of endurance type exercise (cycling and running) lasting for 30, 40, 50, 60 minutes in the week 1, 2, 3 and 4 respectively. The time and day of each training trial will be agreed between the investigator and the participant and will be based around the participant's availability. All exercise sessions will be supervised by a researcher.
Submaximal Exercise Test: Participants will exercise on treadmill at gradually increasing intensities until 85% of maximal heart rate. During the last minute of each of the intensities heart rate will be measured and expired air will be collected by Douglas bag technique and analysed for oxygen consumption and carbon dioxide production. Relation between heart rate and rate of oxygen consumption will be used to predict maximal oxygen consumption, a marker of cardio-respiratory fitness.
- Conditions
- Overweight and Obesity
- Being tested
- Exercise
- Keywords
- Obesity, Exercise, CVD risk factors, Appetite Regulation, Gut Microbiota
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
4-week moderate intensity exercise programme
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 4-week moderate intensity exercise programme Receives: Behavioral: Exercise |
| Control | No intervention | 4 weeks of habitual life style |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota composition
Changes in the gut microbiota composition measured by 16S rRNA amplicon sequencing.
Measured: 12 months
Secondary outcomes (18)
Interleukin-6 (IL-6)
Changes in fasting and postprandial interleukin-6 pre- and post-interventions measured by Human IL-6 ELISA Ready-Set-Go (Affymetrix, eBioscience)
Measured: 3 months
Glucose
Changes in fasting glucose pre- and post-interventions measured by Randox Glucose
Measured: 3 months
Triglycerides
Changes in fasting and postprandial triglycerides pre- and post-interventions measured by Randox Triglycerides
Measured: 3 months
Insulin
Changes in fasting insulin pre- and post-interventions measured by Mercodia Insulin ELISA
Measured: 3 months
Peptide YY (PYY)
Changes in fasting and postprandial peptide YY pre- and post-interventions measured by Human PYY (Total) ELISA (Merc Millipore)
Measured: 12 months
Glucagon-like peptide-1 (GLP-1)
Changes in fasting and postprandial glucagon-like peptide-1 pre- and post-interventions measured by GLP-1 Total ELISA (Merc Millipore)
Measured: 12 months
Subjective appetite
Changes in subjective appetite (hunger, satiety, fullness, prospective food consumption, desire to eat) pre- and post-interventions measured by Visual Analogue Scales (VAS) where respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (minimum score is 0 and maximum score is 100)
Measured: 12 months
Faecal short-chain fatty acids
Changes in concentrations of feacal short-chain fatty acids pre- and post-interventions measured by TRACE 2000 Gas Chromatography (ThermoQuest Ltd)
Measured: 12 months
Faecal pH
Changes in feacal pH between pre- and post-intervention measured by Hanna HI 98140
Measured: 1 month
Body weight
Differences in body weight (kilograms) between pre- and post-intervention measured by TANITA scales (TBF-300)
Measured: 1 month
Height
Height (meters) measured by stadiometer, a vertical ruler with a sliding horizontal paddle which is adjusted to rest on the top of the head
Measured: 1 month
Body fat (kilograms)
Differences in body fat expressed in kilograms between pre- and post-intervention measured by TANITA scales (TBF-300)
Measured: 1 month
Body fat (% percentage)
Differences in body fat expressed as percentage (%) (proportion of fat to the total body weight) between pre- and post-intervention measured by TANITA scales (TBF-300)
Measured: 1 month
Body Mass Index (BMI)
Differences in body mass index (weight and height will be combined to report BMI in kg/m^2) between pre- and post-intervention measured by TANITA scales (TBF-300)
Measured: 1 month
Dietary Intake
Energy intake and macro nutrient intake using WinDiets software based on food composition tables
Measured: 6 months
Maximum Oxygen Consumption
Maximum Oxygen Consumption (ml/kg/min) measured before and after the interventions by Servomex Gas Analyser
Measured: 2 weeks
Energy substrate oxidation
Fat and carbohydrate oxidation in the fasted and postprandial state measured before and after the interventions using indirect calorimetry (Oxycon Pro)
Measured: 6 months
Resting Metabolic Rate
Resting metabolic rate was measured before and after the interventions (Oxycon Pro)
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start16 Sep 2015
- Primary completion30 Nov 2017 (estimated)
- Study completion30 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Konstantinos Gerasimidis, University of Glasgow
- Investigators
- Konstantinos Gerasimidis, BSc MSc PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344133
- Sponsor's protocol ID
- 200140132
- Status last verified
- Nov 2017
- First submitted
- 19 Sep 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a 4-week Moderate Intensity Exercise Programme on Gut Microbiota, Cardiovascular Disease Risk Factors and Appetite Regulation in Overweight Women
- ClinicalTrials.gov ID
- NCT03344133
- Acronym / sponsor ID
- 200140132
- Conditions
- Overweight and Obesity
- Keywords
- Obesity, Exercise, CVD risk factors, Appetite Regulation, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 16 Sep 2015 (actual)
- Primary completion
- 30 Nov 2017 (estimated)
- Study completion
- 30 Nov 2017 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evidence suggests that gut microbiota contributes to the development of atherosclerosis and therefore CVDs. Exercise has been extensively reported to be protective against CVDs due to modification of body fatness, metabolic risk factors and cardio-respiratory fitness. It remains unclear whether impact of exercise on CVD risk can be at least in part explained by changes in the microbiota. It also remains to be investigated whether modification of appetite and appetite hormones due to participation in exercise are related to changes in the gut microbiota composition. Therefore, this study will be conducted in overweight, healthy, sedentary women and will investigate the effect of a 4-week moderate intensity exercise programme on gut microbiota composition and metabolic activity, plasma concentrations of fasting and postprandial lipids, glucose, insulin and inflammatory markers, fasting and postprandial gut appetite hormones, subjective appetite measures and cardio-respiratory fitness.
Detailed description
Study Design: This is a randomized controlled study with a parallel design. Healthy, sedentary females aged between 18-45 years old will be recruited by means of an advertisement leaflet and word of mouth. Eligible participants will be enrolled in the study and will be randomly allocated to either exercise intervention (EX) or control (C) groups. The EX group will participate in a 4-week exercise intervention and the C group will be asked to continue with habitual life style for 4 weeks. Before and after 4 weeks of the intervention, participants from both groups will be asked to conduct a submaximal exercise test and a 7-hour experimental trial during which blood samples will be collected and metabolic rate will measured before and after consumption of standardized breakfast and lunch. Prior to the first 7-hour trial, participants will be asked to record diet for 3 days and replicate this diet prior to the second 7-hour trial. During these 3 days participants will provide fresh stool samples. Participants allocated to control group will have the option to participate in exercise intervention. A subset of the participants will repeat a 7-hour experimental trial and provide fresh stool and urine sample after 7 days of detraining.
Methods:
Preliminary Health Check: Participants will undertake a health screening questionnaire on the day of recruitment. Participants will also need to fill in Physical Activity Readiness Questionnaire (PARQ). Only participants who answered "no" to all questions in PARQ will conduct the submaximal exercise test.
Anthropometry: All participants will have height, weight and waist circumference measured at baseline and 4 weeks after the intervention.
7-hour Experimental Trial: Participants will attend the metabolic suite (New Lister Building, Glasgow Royal infirmary) in a fasted state at approximately 9.00 am. Participants will be instructed to lie supine on the couch, with the head resting on the pillow provided. Resting metabolic rate will be measured for 20 minutes and fasting blood sample will be obtained. A breakfast meal will be consumed immediately after the fasting sample and a lunch meal after 4 hours. Blood samples will be taken throughout a cannula hourly after breakfast and lunch consumption. Following each blood sample, metabolic rate will be measured for the duration of 20 minutes. Prior each blood sample, participants will fill in appetite questionnaires. Blood samples will be analysed for plasma lipids, glucose, insulin, inflammatory markers and gut appetite hormones using standard existing procedures.
Feacal sample collection \& analysis: A disposable stool sample collection kit will be provided prior to the 7-hour trial day. Once collected, the container is sealed and placed in a larger sealable bag with a reducing sachet to remove oxygen and maintain anaerobic bacteria. Stool samples will be measured for changes in gut microbiota based on 16S rRNA amplicon sequencing, bacterial functional capacity and targeted bacterial metabolites (short chain fatty acids, sulphide, ammonia).
Exercise Training Programme: Exercise training will consist of 4 weekly sessions of endurance type exercise (cycling and running) lasting for 30, 40, 50, 60 minutes in the week 1, 2, 3 and 4 respectively. The time and day of each training trial will be agreed between the investigator and the participant and will be based around the participant's availability. All exercise sessions will be supervised by a researcher.
Submaximal Exercise Test: Participants will exercise on treadmill at gradually increasing intensities until 85% of maximal heart rate. During the last minute of each of the intensities heart rate will be measured and expired air will be collected by Douglas bag technique and analysed for oxygen consumption and carbon dioxide production. Relation between heart rate and rate of oxygen consumption will be used to predict maximal oxygen consumption, a marker of cardio-respiratory fitness.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise4-week moderate intensity exercise programme |
| Control | No intervention | –4 weeks of habitual life style |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy, sedentary females, BMI>25 kg/m2, on a stable body weight for the last 3 months
Key exclusion criteria (1 listed)
- Acute or chronic illness, use of antibiotics the past 3 months, smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise4-week moderate intensity exercise programme | Behavioural | Exercise |
Primary outcome
Gut microbiota composition
Time frame: 12 months
Changes in the gut microbiota composition measured by 16S rRNA amplicon sequencing.
18 secondary outcomes
Interleukin-6 (IL-6)
Time frame: 3 months
Glucose
Time frame: 3 months
Triglycerides
Time frame: 3 months
Insulin
Time frame: 3 months
Peptide YY (PYY)
Time frame: 12 months
Glucagon-like peptide-1 (GLP-1)
Time frame: 12 months
Subjective appetite
Time frame: 12 months
Faecal short-chain fatty acids
Time frame: 12 months
Faecal pH
Time frame: 1 month
Body weight
Time frame: 1 month
Height
Time frame: 1 month
Body fat (kilograms)
Time frame: 1 month
Body fat (% percentage)
Time frame: 1 month
Body Mass Index (BMI)
Time frame: 1 month
Dietary Intake
Time frame: 6 months
Maximum Oxygen Consumption
Time frame: 2 weeks
Energy substrate oxidation
Time frame: 6 months
Resting Metabolic Rate
Time frame: 2 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleni Rizou, BSc MSc contact
Konstantinos Gerasimidis, BSc MSc PhD contact
Konstantinos Gerasimidis, BSc MSc PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Overweight and Obesity, run by University of Glasgow 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 1 inclusion and 1 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 17 Nov 2017. 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 Eleni Rizou, BSc MSc (e.rizou.1@research.gla.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota composition (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2017.