Clinical trial NCT04122209: Does the Timing of When High Intensity Intermittent Exercise is Undertaken Matter?
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Loss
Weight Change, Body
Nutritional and Metabolic Disease
Keywords: Nutritional
Metabolic
Endocrine
Lead sponsor: Manchester Metropolitan University
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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 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

1. The order in which continuous and HIIE is undertaken will result in differences in gastric emptying rate after ingesting a semi-sold lunch?
2. 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?
3. 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?
4. 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.

Eligibility criteria: 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. Not vegan or lactose intolerant
8. Subsequently be physically active, in order to complete the trials.

Exclusion Criteria:

1. Not healthy
2. Female
3. Under 18 years
4. Over 40 years
5. Body mass index = \>29.9 kg/m2;
6. Smokers
7. History of GI symptoms or disease,
8. Consuming prescription medication
9. Lactose Intolerant
10. Vegan
11. Subsequently not physically active, in order to complete the trials

Primary outcomes:
measure: Change in gastric emptying rate over a 2-hour period
timeFrame: 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.
measure: Changes in circulating levels of key gut hormones during the trial day
timeFrame: 10 samples will be collected at 0 (baseline), 30, 75, 135, 195, 255, 285, 315, 390, 450 minutes (End of trial)
measure: Changes in circulating levels of key metabolic markers during the trial day
timeFrame: 10 samples will be collected at 0 (baseline), 30, 75, 135, 195, 255, 285, 315, 390, 450 minutes (End of trial)
measure: Changes in substrate oxidation during the trial day
timeFrame: 8 measurements of substrate oxidation will be taken at 0 (baseline), 30, 135, 195, 255, 285, 390, and 450 minutes (End of trial)
measure: Changes in appetite using a visual analogue scales (VAS) questionnaire
timeFrame: 10 VAS questionnaires will be completed at 0 (baseline), 30, 75, 135, 195, 255, 285, 315, 390, 450 minutes (End of trial)
measure: Post trial energy intake
timeFrame: 24-hours post-trial total dietary intake
Secondary outcomes:
measure: Changes in well-being
timeFrame: 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
measure: Changes in perceived exertion
timeFrame: 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
measure: Changes in heart rate during exercise
timeFrame: Continues exercise ( 5, 10, 15, 20, 25 and 30-minutes ) and Intermittent ( 1, 3, 6, 9, 12, 15, 18, 21, 24 and 27-minutes)
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Metropolitan University
Study officials:
affiliation: Manchester Metropolitan University
name: Gethin H Evans, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: McIver 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.
citation: McIver 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.