ClinicalTrials.gg
Status unknownNCT03344133Updated Nov 17, 2017

Effect of Exercise Programme on Gut Microbiota, CVD Risk Factors and Appetite Regulation in Overweight Women

An interventional study of Exercise in Overweight and Obesity, sponsored by University of Glasgow. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-17.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Glasgow · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Sep 2015, registered Sep 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 452 studies in Obesity with a site in United Kingdom — 92 open to participants now, 126 under way, 39 of them phase 3. Obesity · United Kingdom.

Planned enrollment
192nd of 370
60 · median 65
Started
2015
with 18 others
No phase
225 of 452
38 open now
Registered
167th of 452
by date

Among the 452 studies in Obesity with a site in United Kingdom, this one is the 192nd largest by planned enrollment of the 370 interventional ones that give a count, is one of 19 that started in 2015, is one of 225 with no phase, and was the 167th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

92 of the 452 studies in Obesity with a site in United Kingdom are open now. Recruiting first, the newest first:

87 more — sign in →

All 92 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years to 45 Years · female · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 452 studies in Obesity with a site in United Kingdom, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Overweight and Obesity

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Keywords

  • Obesity
  • Exercise
  • CVD risk factors
  • Appetite Regulation
  • Gut Microbiota
04

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 60 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Glasgow is the lead sponsor of 145 studies on the registry; 21 are open to participants now.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy, sedentary females, >25 kg/m2, on a stable body weight for the last 3 months

Exclusion criteria

Exclusion Criteria:

  • Acute or chronic illness, use of antibiotics the past 3 months, smoking
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

06

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Exercise

    4-week moderate intensity exercise programme

    Behavioral: Exercise

  • No intervention
    Control

    4 weeks of habitual life style

Interventions

  • BehavioralExercise

    4-week moderate intensity exercise programme

07

What researchers measure

Primary outcomes

  1. Gut microbiota composition

    Changes in the gut microbiota composition measured by 16S rRNA amplicon sequencing.

    Time frame: 12 months

Secondary outcomes

  1. 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)

    Time frame: 3 months

  2. Glucose

    Changes in fasting glucose pre- and post-interventions measured by Randox Glucose

    Time frame: 3 months

  3. Triglycerides

    Changes in fasting and postprandial triglycerides pre- and post-interventions measured by Randox Triglycerides

    Time frame: 3 months

  4. Insulin

    Changes in fasting insulin pre- and post-interventions measured by Mercodia Insulin ELISA

    Time frame: 3 months

  5. Peptide YY (PYY)

    Changes in fasting and postprandial peptide YY pre- and post-interventions measured by Human PYY (Total) ELISA (Merc Millipore)

    Time frame: 12 months

  6. 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)

    Time frame: 12 months

  7. 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)

    Time frame: 12 months

  8. 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)

    Time frame: 12 months

  9. Faecal pH

    Changes in feacal pH between pre- and post-intervention measured by Hanna HI 98140

    Time frame: 1 month

  10. Body weight

    Differences in body weight (kilograms) between pre- and post-intervention measured by TANITA scales (TBF-300)

    Time frame: 1 month

  11. 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

    Time frame: 1 month

  12. Body fat (kilograms)

    Differences in body fat expressed in kilograms between pre- and post-intervention measured by TANITA scales (TBF-300)

    Time frame: 1 month

  13. 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)

    Time frame: 1 month

  14. 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)

    Time frame: 1 month

  15. Dietary Intake

    Energy intake and macro nutrient intake using WinDiets software based on food composition tables

    Time frame: 6 months

  16. Maximum Oxygen Consumption

    Maximum Oxygen Consumption (ml/kg/min) measured before and after the interventions by Servomex Gas Analyser

    Time frame: 2 weeks

  17. Energy substrate oxidation

    Fat and carbohydrate oxidation in the fasted and postprandial state measured before and after the interventions using indirect calorimetry (Oxycon Pro)

    Time frame: 6 months

  18. Resting Metabolic Rate

    Resting metabolic rate was measured before and after the interventions (Oxycon Pro)

    Time frame: 2 month

08

Study locations

1 of 1 sites recruiting
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2015 (actual). Primary completion is estimated for Nov 2017, 26 months after the start.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 26 months is above that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2017
First posted
Nov 17, 2017
StartActual
Sep 16, 2015
Primary completionEst.
Nov 30, 2017
CompletionEst.
Nov 30, 2017
Last update
Nov 17, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03344133
Responsible party
Dr Konstantinos Gerasimidis (Senior Lecturer, University of Glasgow) — Principal investigator
First posted
Nov 17, 2017
Start date
Sep 16, 2015
Primary completion
Nov 30, 2017 (estimated)
Completion
Nov 30, 2017 (estimated)
Last update
Nov 17, 2017

Study contacts

Eleni Rizou, BSc MSc
Contact
e.rizou.1@research.gla.ac.uk
Konstantinos Gerasimidis, BSc MSc PhD
Contact
Konstantinos.Gerasimidis@glasgow.ac.uk
Konstantinos Gerasimidis, BSc MSc PhD
principal investigator · University of Glasgow

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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