Is it more beneficial for appetite and weight management to exercise once or twice a day?
| ISRCTN | ISRCTN48264634 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48264634 |
| Secondary identifying numbers | LRM-1089 |
- Submission date
- 07/12/2018
- Registration date
- 11/12/2018
- Last edited
- 16/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
There is a growing amount of literature committed to understanding if being more active will have beneficial effect on health. However, less is known on whether performing exercise twice a day is more beneficial than exercising once when matched for workload. Therefore, the aim of this study is to identify if workload matched exercise split over the day, will result in possible changes in gastrointestinal function, metabolic responses and appetite.
Who can participate ?
Healthy males (age 18-40 years; body mass index <29.9 kg/m2; non-smokers, no history of GI symptoms not consuming prescription medication and subsequently be physically active, in order to complete the trials.
What are the possible benefits and risks of participating?
1. Full fitness assessment
2. Information about the participants diet
3. Knowledge about how gastric emptying may affect exercise
4. Experience within a research laboratory
What does the study involve?
The study involves two non-consecutive test days in a randomised order. After a 24 hour standardisation period and overnight fast. Participants come to the laboratory and exercise; either split over the day (two, 30min cycles) or a one-off bout (60-min cycle) before consuming a milk-shake and a standardised semi-solid meal. Throughout the trial, measurements of subjective feelings of appetite, gastric emptying rate, substrate utilisation and 24-hour energy intake. Blood samples will also be taken regularly throughout the trials.
Where is the study run from?
Manchester Metropolitan University , Manchester (UK)
Who is funding the study?
Manchester Metropolitan university
When is the study starting and how long is it expected to run for?
December 2018 to September 2019
Who is the Main Contact?
Mr Lewis Mattin
lewis.mattin@stu.mmu.ac.uk
Contact information
Scientific
School of Healthcare Science
Manchester Metropolitan University
Chester Street
Manchester
M1 5GD
United Kingdom
| Phone | +44 (0)1612471208 |
|---|---|
| gethin.evans@mmu.ac.uk |
Public
School of Healthcare Science
Manchester Metropolitan University
Chester Street
Manchester
M1 5GD
United Kingdom
| Phone | +44 (0)1612471215 |
|---|---|
| lewis.mattin@stu.mmu.ac.uk |
Study information
| Study design | Interventional, repeated measures with randomised crossover |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format please use contact details to request a participants information sheet |
| Scientific title | The effect of exercising once vs. twice a day on gastrointestinal function, metabolic responses and appetite in healthy males: a randomised cross over trial. |
| Study acronym | Split exercise |
| Study hypothesis | 1. Exercising twice a day will result in differences in gastric emptying rate and metabolic responses compared to a single workload-matched bout of exercise. 2. Exercising twice a day will result in differences in appetite and gut hormone responses compared to a single workload-matched bout of exercise. |
| Ethics approval(s) | The Faculty of Science and Engineering Research Ethics and Governance Committee at Manchester Metropolitan University, 11/2018, ref. 1089 |
| Condition | Obesity |
| Intervention | Participants will complete two 7h experimental trials in a randomised cross-over design, where each participant will complete both trial arms; exercise once and twice a day separated by a minimum of 7 days. One trial will consist of a one off 60-min cycle at 70% peak maximal oxygen uptake. After completion of this single bout of exercise, participants will ingest a milkshake containing 30% of their estimated energy expenditure through the trial. Following a rest period the remaining 70% of their estimated energy expenditure through the trial will be provide as a semi-solid meal. The second trial will consist of a 30-min cycle before participants will ingest a milkshake followed by the same rest period before completing the remaining 30-min cycle and ingestion of a semi-solid meal. There will be no follow up session apart from all participant will record 24-h food intake following both trials. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Gastric emptying rate of a semi-solid meal will be measured using the 13C breath test . Breath samples will be collected at baseline and every 15min for a two-hour period. 2. Circulating levels of key gut hormones and metabolic markers. Blood samples will be collected at baseline, pre-milkshake, 1h-post milkshake, 2h-post milkshake, pre-semi-solid meal ingestion, 1-h post meal ingestion and 2h post meal ingestion 3. Substrate oxidation will be measured using a breath-by breath gas analyser at rest, during exercise sessions and every 30 min post food ingestion for 2h 4. Visual analogue scales will be used to measure subjective sensations of appetite at rest, pre-meal ingestion and every 30min post food ingestion for 2h. 5. 24h post trial energy intake using weighed food intake dietary record |
| Secondary outcome measures | 1. Ratings of perceived exertion using the Borg scale and heart rate will be recorded pre exercise and every 15min during exercise |
| Overall study start date | 26/07/2018 |
| Overall study end date | 30/08/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Male |
| Target number of participants | 14 participants |
| Total final enrolment | 16 |
| Participant inclusion criteria | 1. Healthy males 2. Age between 18-40 years 3. Body mass index = <29.9 kg/m2 4. Non-smokers 5. No history of GI symptoms 6. Not consuming prescription medication, or no other relevant medical conditions assessed by a medical screening questionnaire. 7. Subsequently be physically active, in order to complete the trials. |
| Participant exclusion criteria | 1. Lactose Intolerant 2. Vegan |
| Recruitment start date | 17/12/2018 |
| Recruitment end date | 10/04/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Healthcare Science
Chester Street
Manchester
M1 5GD
United Kingdom
Sponsor information
University/education
School of Healthcare Science
Faculty of Sciences and Engineering
Chester Street
Manchester
M1 5GD
England
United Kingdom
| Phone | 01612472818 |
|---|---|
| Justine.Daniel@mmu.ac.uk | |
"ROR" |
https://ror.org/02hstj355 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- MMU
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned communication of results at a scientific conference . Planned publication in a high impact peer reviewed journal within 12 months of the completion of the study |
| IPD sharing plan | Participant level data is not expected to be available as this complies with the conditions of the ethical approval grated for this study. |
Editorial Notes
16/02/2021: Internal review.
05/09/2019: The following changes have been made:
1. The recruitment end date has been changed from 31/08/2019 to 10/04/2019.
2. The overall trial end date has been changed from 30/09/2019 to 30/08/2019.
3. The intention to publish date was changed from 20/05/2020 to 30/08/2020.
4. The final enrolment number was added.
18/12/2018: Internal review.
