Weight LossHIIENCT04122209
Does the Timing of When High Intensity Intermittent Exercise is Undertaken Matter?
A study testing HIIE-First and Continuous-First in people with Weight Loss and Weight Change, Body, run by Manchester Metropolitan University at 1 site in United Kingdom.
Trial summary
The participants will visit the laboratory on 3 occasions, once for a preliminary visit and a further two occasions to complete experimental trials in a randomised order. The experimental trials will consist of cycling under two conditions; HIIE-First followed by Continuous (Trial-A) or Continuous-First followed by… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Weight Change, Body, Nutritional and Metabolic Disease
- What is being tested?
- HIIE-First and Continuous-First
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2019to 31 Aug 2020
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Age between 18-40 years
- Body mass index = <29.9 kg/m2
- Non-smokers
- No history of GI symptoms
- Not consuming prescription medication, or no other relevant medical conditions assessed by a medical screening questionnaire.
- Not vegan or lactose intolerant
- Subsequently be physically active, in order to complete the trials.
Who cannot join
- Not healthy
- Female
- Under 18 years
- Over 40 years
- Body mass index = >29.9 kg/m2;
- Smokers
Show all 11Show fewer
- History of GI symptoms or disease,
- Consuming prescription medication
- Lactose Intolerant
- Vegan
- Subsequently not physically active, in order to complete the trials
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester Metropolitan University
Manchester, M1 5GD
Lewis R Mattin, MRs, 01612471215, l.mattin@mmu.ac.uk
Gethin H Evans, PhD, 01612471208, gethin.evans@mmu.ac.uk
About this study
Official title: The Effect of Multiple Exercise Bouts During the Same Day (Continuous and High Intensity Intermittent Exercise), on Gastrointestinal Function, Appetite and Metabolic Response in Healthy Males: a Randomised Cross Over Trial
The participants will visit the laboratory on 3 occasions, once for a preliminary visit and a further two occasions to complete experimental trials in a randomised order. The experimental trials will consist of cycling under two conditions; HIIE-First followed by Continuous (Trial-A) or Continuous-First followed by HIIE (Trial-B). Participants will be asked to standardise their diet for 24-hours and complete an overnight fast prior to visiting the laboratory. Participants will then complete 60-min of cycling split throughout the day into two 30-min bouts, HIIE or continuous cycling before breakfast followed by a 3.5 hour rest period before completing their remaining 30-min HIIE or Continuous cycling before lunch. Each experimental trail will last approximately 8 hours and begin at 08:00am. Throughout the trial measurements of subjective feelings of appetite, gastric emptying rate, substrate utilisation and regular blood samples will be taken. Post-trial nutritional and well-being questionnaires will be collected at 24-h post.
Study hypothesis
- The order in which continuous and HIIE is undertaken will result in differences in gastric emptying rate after ingesting a semi-sold lunch?
- Depending on which mode of exercise is undertaken first will result in different gastrointestinal hormone responses, metabolic responses and appetite responses throughout the trial day?
- Will the order in which different modes of exercise, undertaken within the same day effect nutritional intake and well-being 24-h after both exercise bout have been completed?
- Is substrate oxidation effected by the order in which multiple exercise bout of different modes are undertaken within the same day.
Read the detailed description
There is a growing amount of literature committed to understanding if becoming more active will have beneficial effects on metabolic health; secondly do the traditional physical exercise and dietary approaches to managing obesity result in prolonged weight loss. The purpose of this study is to determine whether high intensity intermittent exercise (HIIE) and continuous exercise carried out in differing sequences within a day will have a beneficial health impact.
Participants will complete two 8h experimental trials in a randomised cross-over design. Each participant will complete 60-min of exercise in both trial arms; HIIE-First or Continuous-First separated by a minimum of 7 days. One trial will consist of a 30-min HIIE cycling session (10 x 1min of peak power output followed by 2min rest). After completion of this bout of exercise, participants will ingest a standardised breakfast. Following a rest period of 3h before completing the remaining 30-min of exercise (50% peak maximal oxygen uptake), before consuming a standardised semi-sold lunch meal. The second trial will be identical other than participates will undertake the continuous exercise first followed by the HIIE. Regular appetite, 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 and record their feeling of well-being documented on a questionnaire. There will be no long-term follow up following completion of the study.
Therefore, the aim of this research project is to identify whether the order of HIIE and continuous exercise separated within the day results in changes to gastrointestinal health, appetite, and metabolic responses.
- Being tested
- HIIE-First, Continuous-First
- Keywords
- Nutritional, Metabolic, Endocrine
- Medical subject headings
- Weight Loss, Body Weight Changes, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIE-FirstOther
Multiple exercise bout during the same day; HIIE first followed by continuous exercise
Continuous-FirstOther
Multiple exercise bout during the same day; Continuous exercise first followed by HIIE
| Study group | Role | What they receive |
|---|---|---|
| HIIE-First | Experimental | 60-min of exercise split into; firstly 30-min HIIE (10 x 1min of PPO, followed by 2-min rest). Secondly 30-min of continuous exercise (50% peak maximal oxygen uptake). Receives: Other: HIIE-First |
| Continuous-First | Experimental | 60-min of exercise split into; firstly 30-min of continuous exercise (50% peak maximal oxygen uptake). Secondly 30-min HIIE (10 x 1min of PPO, followed by 2-min rest) Receives: Other: Continuous-First |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gastric emptying rate over a 2-hour period
Gastric emptying rate of a semi-solid meal will be measured using the 13C breath test.
Measured: 9 breath samples will be collected at pre-Lunch (315 minutes), 345, 360, 375, 390, 405, 420, 435 and 450 minutes. Which is every 15 minutes for a two-hour period post-lunch.
Changes in circulating levels of key gut hormones during the trial day
Hormones will be collected from serum blood samples
Measured: 10 samples will be collected at 0 (baseline), 30, 75, 135, 195, 255, 285, 315, 390, 450 minutes (End of trial)
Changes in circulating levels of key metabolic markers during the trial day
Serum blood samples will be collected to measure Metabolic markers ( Glucose, triglycerides, Cholesterol and Non-esterified fatty acids)
Measured: 10 samples will be collected at 0 (baseline), 30, 75, 135, 195, 255, 285, 315, 390, 450 minutes (End of trial)
Changes in substrate oxidation during the trial day
Substrate oxidation will be measured using a breath-by breath gas analyser for a 15-minutes period during each measurement
Measured: 8 measurements of substrate oxidation will be taken at 0 (baseline), 30, 135, 195, 255, 285, 390, and 450 minutes (End of trial)
Changes in appetite using a visual analogue scales (VAS) questionnaire
Visual analogue scales will be used to measure subjective sensations of appetite. The VAS was composed of 6 questions asking: "how hungry do you feel?" "How full do you feel?" "How much do you think you can eat?" "How satisfied do you feel?" " How nauseous do you feel?" and " How bloated do you feel?". Horizontal lines 100 mm in length were anchored with "I am not hungry at all to I have never been more hungry," "Not at all full to totally full," "nothing at all to a lot," "I am completely empty to I can't eat another bite" " Not at all nauseous to Very nauseous" and " Not at all bloated to Very Bloated" at 0 mm and 100 mm, respectively.
Measured: 10 VAS questionnaires will be completed at 0 (baseline), 30, 75, 135, 195, 255, 285, 315, 390, 450 minutes (End of trial)
Post trial energy intake
24-hour post trial energy intake using weighed food intake dietary record
Measured: 24-hours post-trial total dietary intake
Secondary outcomes (3)
Changes in well-being
Well-being will be assessed with an in-house questionnaire. Before each trial session participants will answered the following questions: 1) how sore do your muscles feel ? 2) How fatigued do you feel today? 3) How is your mood? 4) How stressed do you feel today? 5) How sleepy do you feel?. Each question will be scored between 1 (low) and 7 (high). A sum of scores for the 5 questions will be used for data analysis.
Measured: 6 questionnaires will be completed; pre (0-minutes) and post first exercise bout (30-minutes), and pre (255-minutes) and post second exercise bout (285-minutes). End of the trial day (450-minutes), and 24-hours post-trial
Changes in perceived exertion
Ratings of perceived exertion using the Borg scale will be recorded during exercise. Perceived exertion will be measured every 5-minutes during both 30-minutes exercise periods
Measured: Perceived exertion will be asked 12 times; 6 during the first 30-minutes exercise period ( 5, 10, 15. 20, 25 and 30-minutes) and a further 6 times during the second exercise period (5, 10, 15, 20, 25 and 30-minutes
Changes in heart rate during exercise
Heart rate will be measured every 5-minutes during the continues exercise and every 3-minutes during the intermittent exercise
Measured: Continues exercise ( 5, 10, 15, 20, 25 and 30-minutes ) and Intermittent ( 1, 3, 6, 9, 12, 15, 18, 21, 24 and 27-minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start16 Oct 2019
- Primary completion18 May 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lewis R Mattin, Manchester Metropolitan University
- Investigators
- Gethin H Evans, PhD, Study director, Manchester Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122209
- Sponsor's protocol ID
- LRM-11619
- Acronym
- HIIE
- Status last verified
- Oct 2019
- First submitted
- 3 Sep 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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 statement: Participants level data is not expected to be available as this complies with the conditions of the ethical approval grated for this study
Publications
Mattin LR, Yau AMW, McIver V, James LJ, Evans GH. The Effect of Exercise Intensity on Gastric Emptying Rate, Appetite and Gut Derived Hormone Responses after Consuming a Standardised Semi-Solid Meal in Healthy Males. Nutrients. 2018 Jun 19;10(6):787. doi: 10.3390/nu10060787.
PubMed 29921786McIver VJ, Mattin LR, Evans GH, Yau AMW. Diurnal influences of fasted and non-fasted brisk walking on gastric emptying rate, metabolic responses, and appetite in healthy males. Appetite. 2019 Dec 1;143:104411. doi: 10.1016/j.appet.2019.104411. Epub 2019 Aug 21.
PubMed 31445052McIver VJ, Mattin L, Evans GH, Yau AMW. The effect of brisk walking in the fasted versus fed state on metabolic responses, gastrointestinal function, and appetite in healthy men. Int J Obes (Lond). 2019 Sep;43(9):1691-1700. doi: 10.1038/s41366-018-0215-x. Epub 2018 Sep 24.
PubMed 30250241
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multiple Exercise Bouts During the Same Day (Continuous and High Intensity Intermittent Exercise), on Gastrointestinal Function, Appetite and Metabolic Response in Healthy Males: a Randomised Cross Over Trial
- ClinicalTrials.gov ID
- NCT04122209
- Acronym / sponsor ID
- HIIE / LRM-11619
- Keywords
- Nutritional, Metabolic, Endocrine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Manchester Metropolitan UniversityUniversity, hospital or other
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 18 May 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 10 Oct 2019 (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.
The participants will visit the laboratory on 3 occasions, once for a preliminary visit and a further two occasions to complete experimental trials in a randomised order. The experimental trials will consist of cycling under two conditions; HIIE-First followed by Continuous (Trial-A) or Continuous-First followed by HIIE (Trial-B). Participants will be asked to standardise their diet for 24-hours and complete an overnight fast prior to visiting the laboratory. Participants will then complete 60-min of cycling split throughout the day into two 30-min bouts, HIIE or continuous cycling before breakfast followed by a 3.5 hour rest period before completing their remaining 30-min HIIE or Continuous cycling before lunch. Each experimental trail will last approximately 8 hours and begin at 08:00am. Throughout the trial measurements of subjective feelings of appetite, gastric emptying rate, substrate utilisation and regular blood samples will be taken. Post-trial nutritional and well-being questionnaires will be collected at 24-h post.
Study hypothesis
- The order in which continuous and HIIE is undertaken will result in differences in gastric emptying rate after ingesting a semi-sold lunch?
- Depending on which mode of exercise is undertaken first will result in different gastrointestinal hormone responses, metabolic responses and appetite responses throughout the trial day?
- Will the order in which different modes of exercise, undertaken within the same day effect nutritional intake and well-being 24-h after both exercise bout have been completed?
- Is substrate oxidation effected by the order in which multiple exercise bout of different modes are undertaken within the same day.
Detailed description
There is a growing amount of literature committed to understanding if becoming more active will have beneficial effects on metabolic health; secondly do the traditional physical exercise and dietary approaches to managing obesity result in prolonged weight loss. The purpose of this study is to determine whether high intensity intermittent exercise (HIIE) and continuous exercise carried out in differing sequences within a day will have a beneficial health impact.
Participants will complete two 8h experimental trials in a randomised cross-over design. Each participant will complete 60-min of exercise in both trial arms; HIIE-First or Continuous-First separated by a minimum of 7 days. One trial will consist of a 30-min HIIE cycling session (10 x 1min of peak power output followed by 2min rest). After completion of this bout of exercise, participants will ingest a standardised breakfast. Following a rest period of 3h before completing the remaining 30-min of exercise (50% peak maximal oxygen uptake), before consuming a standardised semi-sold lunch meal. The second trial will be identical other than participates will undertake the continuous exercise first followed by the HIIE. Regular appetite, 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 and record their feeling of well-being documented on a questionnaire. There will be no long-term follow up following completion of the study.
Therefore, the aim of this research project is to identify whether the order of HIIE and continuous exercise separated within the day results in changes to gastrointestinal health, appetite, and metabolic responses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIIE-First | Experimental | Other: HIIE-First60-min of exercise split into; firstly 30-min HIIE (10 x 1min of PPO, followed by 2-min rest). Secondly 30-min of continuous exercise (50% peak maximal oxygen uptake). |
| Continuous-First | Experimental | Other: Continuous-First60-min of exercise split into; firstly 30-min of continuous exercise (50% peak maximal oxygen uptake). Secondly 30-min HIIE (10 x 1min of PPO, followed by 2-min rest) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy males
- Age between 18-40 years
- Body mass index = <29.9 kg/m2
- Non-smokers
- No history of GI symptoms
Key exclusion criteria (11 listed)
- Not healthy
- Female
- Under 18 years
- Over 40 years
- Body mass index = >29.9 kg/m2;
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 |
|---|---|---|
| HIIE-FirstMultiple exercise bout during the same day; HIIE first followed by continuous exercise | Other | HIIE-First |
| Continuous-FirstMultiple exercise bout during the same day; Continuous exercise first followed by HIIE | Other | Continuous-First |
Primary outcome
Change in gastric emptying rate over a 2-hour period
Time frame: 9 breath samples will be collected at pre-Lunch (315 minutes), 345, 360, 375, 390, 405, 420, 435 and 450 minutes. Which is every 15 minutes for a two-hour period post-lunch.
Gastric emptying rate of a semi-solid meal will be measured using the 13C breath test.
Changes in circulating levels of key gut hormones during the trial day
Time frame: 10 samples will be collected at 0 (baseline), 30, 75, 135, 195, 255, 285, 315, 390, 450 minutes (End of trial)
Hormones will be collected from serum blood samples
Changes in circulating levels of key metabolic markers during the trial day
Time frame: 10 samples will be collected at 0 (baseline), 30, 75, 135, 195, 255, 285, 315, 390, 450 minutes (End of trial)
Serum blood samples will be collected to measure Metabolic markers ( Glucose, triglycerides, Cholesterol and Non-esterified fatty acids)
Changes in substrate oxidation during the trial day
Time frame: 8 measurements of substrate oxidation will be taken at 0 (baseline), 30, 135, 195, 255, 285, 390, and 450 minutes (End of trial)
Substrate oxidation will be measured using a breath-by breath gas analyser for a 15-minutes period during each measurement
Changes in appetite using a visual analogue scales (VAS) questionnaire
Time frame: 10 VAS questionnaires will be completed at 0 (baseline), 30, 75, 135, 195, 255, 285, 315, 390, 450 minutes (End of trial)
Visual analogue scales will be used to measure subjective sensations of appetite. The VAS was composed of 6 questions asking: "how hungry do you feel?" "How full do you feel?" "How much do you think you can eat?" "How satisfied do you feel?" " How nauseous do you feel?" and " How bloated do you feel?". Horizontal lines 100 mm in length were anchored with "I am not hungry at all to I have never been more hungry," "Not at all full to totally full," "nothing at all to a lot," "I am completely empty to I can't eat another bite" " Not at all nauseous to Very nauseous" and " Not at all bloated to Very Bloated" at 0 mm and 100 mm, respectively.
Post trial energy intake
Time frame: 24-hours post-trial total dietary intake
24-hour post trial energy intake using weighed food intake dietary record
3 secondary outcomes
Changes in well-being
Time frame: 6 questionnaires will be completed; pre (0-minutes) and post first exercise bout (30-minutes), and pre (255-minutes) and post second exercise bout (285-minutes). End of the trial day (450-minutes), and 24-hours post-trial
Changes in perceived exertion
Time frame: Perceived exertion will be asked 12 times; 6 during the first 30-minutes exercise period ( 5, 10, 15. 20, 25 and 30-minutes) and a further 6 times during the second exercise period (5, 10, 15, 20, 25 and 30-minutes
Changes in heart rate during exercise
Time frame: Continues exercise ( 5, 10, 15, 20, 25 and 30-minutes ) and Intermittent ( 1, 3, 6, 9, 12, 15, 18, 21, 24 and 27-minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Background: PubMed 29921786Mattin LR, Yau AMW, McIver V, James LJ, Evans GH. The Effect of Exercise Intensity on Gastric Emptying Rate, Appetite and Gut Derived Hormone Responses after Consuming a Standardised Semi-Solid Meal in Healthy Males. Nutrients. 2018 Jun 19;10(6):787. doi: 10.3390/nu10060787.
- Background: PubMed 31445052McIver VJ, Mattin LR, Evans GH, Yau AMW. Diurnal influences of fasted and non-fasted brisk walking on gastric emptying rate, metabolic responses, and appetite in healthy males. Appetite. 2019 Dec 1;143:104411. doi: 10.1016/j.appet.2019.104411. Epub 2019 Aug 21.
- Background: PubMed 30250241McIver VJ, Mattin L, Evans GH, Yau AMW. The effect of brisk walking in the fasted versus fed state on metabolic responses, gastrointestinal function, and appetite in healthy men. Int J Obes (Lond). 2019 Sep;43(9):1691-1700. doi: 10.1038/s41366-018-0215-x. Epub 2018 Sep 24.
- Individual participant dataSharing planned: No. 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 statement: Participants level data is not expected to be available as this complies with the conditions of the ethical approval grated for this study
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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.
Gethin H Evans, PhD study director
Manchester Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIE-First and Continuous-First in people with Weight Loss and Weight Change, Body, run by Manchester Metropolitan University 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 8 inclusion and 11 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 Oct 2019. 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 Lewis R Mattin, MRs (01612471215, l.mattin@mmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gastric emptying rate over a 2-hour period (time frame: 9 breath samples will be collected at pre-Lunch (315 minutes), 345, 360, 375, 390, 405, 420, 435 and 450 minutes. Which is every 15 minutes for a two-hour period post-lunch.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04122209, which also lists 3 linked publications.
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 Oct 2019.