The effect of fasted and non-fasted cycling at different times of the day on appetite regulation, digestive function and metabolism in healthy overweight individuals
| ISRCTN | ISRCTN11880065 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11880065 |
| Protocol serial number | VJM_0878 |
| Sponsor | Manchester Metropolitan University |
| Funders | Manchester Metropolitan University, Physiological Society |
- Submission date
- 07/12/2018
- Registration date
- 10/12/2018
- Last edited
- 13/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Growing interest in nutrition and the circadian system has produced many insights within recent years, with research suggesting circadian rhythms, nutrition and metabolism to be intimately linked. Intermittent fasting has become an increasingly popular intervention for metabolic health and combining intermittent fasting with exercise may lead to benefits for weight management. Therefore, the aim of this study is to investigate the effect of fasted versus fed exercise at different times of the day on gastrointestinal function, metabolic responses, and appetite responses, in overweight individuals.
Who can participate?
Males aged 18-40 years who are non-smokers and have a body mass index (BMI) class of 25-29.9 kg/m2 but otherwise healthy.
What does the study involve?
The participants will visit the laboratory on 5 occasions, once for a preliminary visit and on four other occasions to complete four separate experimental trials, two in the morning and two in the late afternoon. Experimental trials will consist of cycling exercise under 4 conditions; morning fed (AM-F), morning fasted (AM-NF), late afternoon fed (PM-F) and late afternoon fasted (PM-NF). Each experimental trial will last approximately 5.5 hours and begin at 0800 h for AM trials and 1500 h for PM trials. The AM-F and PM-F trials will consist of ingestion of a standardised breakfast meal one hour in advance of the exercise, whilst in the AM-NF and PM-NF trials, participants will not ingest the breakfast meal and remain fasted for the exercise. After the exercise participants will be provided with a standardised semi-solid meal. Regular breath and blood samples will be taken throughout the trials.
What are the possible benefits and risks of participating?
Participants will be able to receive data on their current aerobic fitness, body composition, and dietary analysis. Apart from this, there will be no immediate direct benefits to participants taking part. However, the results and participants’ experiences in the study will aid the research team in understanding the effect of fasting and exercise on the regulation of appetite and help develop further research on interventions that may help people improve their health. There is a small risk of muscle soreness and discomfort after each exercise session and a small risk of infection and discomfort from blood sampling.
Where is the study run from?
Manchester Metropolitan University.
When is the study starting and how long is it expected to run for?
December 2018 – September 2019
Who is funding the study?
Manchester Metropolitan University and The Physiological Society (research grant)
Who is the main contact?
Dr Adora Yau, a.yau@mmu.ac.uk
Contact information
Public
NB443, Northumberland Building
Northumbria University
Newcastle upon Tyne
NE1 8ST
United Kingdom
| Phone | +44 (0)191 227 3910 |
|---|---|
| Victoria.mciver@northumbria.ac.uk |
Scientific
School of Healthcare Science, Faculty of Science and Engineering, Manchester Metropolitan University, Chester Street
Manchester
M1 5GD
United Kingdom
 ORCID ID |
0000-0001-9969-3764 |
|---|---|
| Phone | +441612475504 |
| a.yau@mmu.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional, repeated measures design with randomised crossover |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Implications of fasted cycling exercise on metabolic responses, gastrointestinal function, and appetite, in overweight individuals |
| Study acronym | FastExOverweight |
| Study objectives | 1. Fasted exercise will result in differences in gastric emptying rate compared to fed exercise. 2. Fed or fasted exercise in the morning will result in differences in gastric emptying rate compared to fed or fasted exercise in the evening. 3. Fasted exercise will result in different gastrointestinal hormone responses, metabolic responses and appetite responses compared to fed exercise. 4. Fasted or fed exercise in the morning would result in differences in gastrointestinal hormone responses, metabolic responses and appetite responses compared to fasted or fed exercise in the evening. |
| Ethics approval(s) | Manchester Metropolitan University faculty of Science and Engineering Research Ethics and Governance Committee, 10/2018, ref. 0878. |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | The participants will complete four experimental trials in a randomised crossover design. Experimental trials will consist of 60 minutes of cycling under 4 conditions; morning fed (AM-F), morning fasted (AM-NF), late afternoon fed (PM-F) and late afternoon fasted (PM-NF). Each experimental trial will last approximately 5.5 hours and begin at 0800 h for AM trials and 1500 h for PM trials. Trials will be separated by a minimum of 7 days. The AM-F and PM-F trials will consist of ingestion of a standardised breakfast meal one hour in advance of 60 min of cycling exercise at approximately 60% peak maximal oxygen uptake, whilst in the AM-NF and PM-NF trials, participants will not ingest the breakfast and remain fasted for the same exercise. After the exercise in all four trials participants will be provided with a standardised semi-solid meal to ingest. Regular breath and blood samples will be taken throughout the trials. In the 24 hours following the end of each trial, participants will be asked to record their dietary intake. There will be no long term follow up following completion of the study. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Gastric emptying rate of a semi-solid meal that will be provided 30 minutes following the cessation of the cycling exercise will be measured using the 13C breath test method. |
| Key secondary outcome measure(s) |
1. Salivary melatonin concentration at the start of the trials. |
| Completion date | 24/05/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Male |
| Target sample size at registration | 12 |
| Total final enrolment | 12 |
| Key inclusion criteria | 1. Male. 2. Aged 18-40 years. 3. Non-smokers. 4. Classified as overweight according to body mass index (BMI) class of 25-29.9 kg/m2 and body fat %. 5. Able and willing to comply with study procedures. 6. Willing to undertake required fasting duration, and with the capacity to provide informed consent 7. Free from injury prior to commencing the trials (6+months), with 1+ year free from any injury (such as, lower limb musculoskeletal injuries) that may have prevented and/or affected the participant. from performing cycling previously. 8. Classified as moderate or intermediate chronotypes according to the questionnaire of Waterhouse et al (2001). |
| Key exclusion criteria | 1. Regular medication or any known history of gastrointestinal, respiratory, cardiovascular, or endocrine disease. 2. Early circadian phase also known as extreme morning chronotypes and extreme evening chronotypes. 3. Involved in shift work and report any disturbances to their normal sleep-wake cycle during the two weeks prior to data collection. 4. Cannot consume the test meals due to intolerance's/dietary preferences. |
| Date of first enrolment | 12/12/2018 |
| Date of final enrolment | 03/04/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Manchester
M1 5GD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the conditions of the ethical approval granted for this study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/09/2021: Abstract and thesis added.
15/06/2021: The following changes were made to the trial record:
1. Contact details updated.
2. The intention to publish date was changed from 31/05/2020 to 31/05/2022.
13/09/2019: The following changes have been made:
1. The recruitment end date has been changed from 31/08/2019 to 03/04/2019.
2. The final enrolment number has been added.
3. The overall trial end date has been changed from 31/08/2019 to 24/05/2019.
19/12/2018: Internal review.
12/12/2018: The recruitment start date was changed from 17/12/2018 to 12/12/2018.
