Does the Timing of When High Intensity Intermittent Exercise is Undertaken Matter? (HIIE)
Primary Purpose
Weight Loss, Weight Change, Body, Nutritional and Metabolic Disease
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
HIIE-First
Continuous-First
Sponsored by
About this trial
This is an interventional basic science trial for Weight Loss focused on measuring Nutritional, Metabolic, Endocrine
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Not healthy
- Female
- Under 18 years
- Over 40 years
- Body mass index = >29.9 kg/m2;
- Smokers
- History of GI symptoms or disease,
- Consuming prescription medication
- Lactose Intolerant
- Vegan
- Subsequently not physically active, in order to complete the trials
Sites / Locations
- Manchester Metropolitan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HIIE-First
Continuous-First
Arm Description
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).
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)
Outcomes
Primary Outcome Measures
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.
Changes in circulating levels of key gut hormones during the trial day
Hormones will be collected from serum blood samples
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)
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
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.
Post trial energy intake
24-hour post trial energy intake using weighed food intake dietary record
Secondary Outcome Measures
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.
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
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
Full Information
NCT ID
NCT04122209
First Posted
September 3, 2019
Last Updated
October 16, 2019
Sponsor
Manchester Metropolitan University
1. Study Identification
Unique Protocol Identification Number
NCT04122209
Brief Title
Does the Timing of When High Intensity Intermittent Exercise is Undertaken Matter?
Acronym
HIIE
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
May 18, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Manchester Metropolitan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Weight Change, Body, Nutritional and Metabolic Disease
Keywords
Nutritional, Metabolic, Endocrine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HIIE-First
Arm Type
Experimental
Arm Description
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).
Arm Title
Continuous-First
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
HIIE-First
Intervention Description
Multiple exercise bout during the same day; HIIE first followed by continuous exercise
Intervention Type
Other
Intervention Name(s)
Continuous-First
Intervention Description
Multiple exercise bout during the same day; Continuous exercise first followed by HIIE
Primary Outcome Measure Information:
Title
Change in gastric emptying rate over a 2-hour period
Description
Gastric emptying rate of a semi-solid meal will be measured using the 13C breath test.
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.
Title
Changes in circulating levels of key gut hormones during the trial day
Description
Hormones will be collected from serum blood samples
Time Frame
10 samples will be collected at 0 (baseline), 30, 75, 135, 195, 255, 285, 315, 390, 450 minutes (End of trial)
Title
Changes in circulating levels of key metabolic markers during the trial day
Description
Serum blood samples will be collected to measure Metabolic markers ( Glucose, triglycerides, Cholesterol and Non-esterified fatty acids)
Time Frame
10 samples will be collected at 0 (baseline), 30, 75, 135, 195, 255, 285, 315, 390, 450 minutes (End of trial)
Title
Changes in substrate oxidation during the trial day
Description
Substrate oxidation will be measured using a breath-by breath gas analyser for a 15-minutes period during each measurement
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)
Title
Changes in appetite using a visual analogue scales (VAS) questionnaire
Description
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.
Time Frame
10 VAS questionnaires will be completed at 0 (baseline), 30, 75, 135, 195, 255, 285, 315, 390, 450 minutes (End of trial)
Title
Post trial energy intake
Description
24-hour post trial energy intake using weighed food intake dietary record
Time Frame
24-hours post-trial total dietary intake
Secondary Outcome Measure Information:
Title
Changes in well-being
Description
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.
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
Title
Changes in perceived exertion
Description
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
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
Title
Changes in heart rate during exercise
Description
Heart rate will be measured every 5-minutes during the continues exercise and every 3-minutes during the intermittent 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)
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male participants will be recruited for this study, as we are unsure if hormonal responses between males and females would influence the outcomes within key measurements. Introducing females within this research area is important. However, for this current study we were particularly interested in data from male participates only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Not healthy
Female
Under 18 years
Over 40 years
Body mass index = >29.9 kg/m2;
Smokers
History of GI symptoms or disease,
Consuming prescription medication
Lactose Intolerant
Vegan
Subsequently not physically active, in order to complete the trials
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lewis R Mattin, MRs
Phone
01612471215
Email
l.mattin@mmu.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Gethin H Evans, PhD
Phone
01612471208
Email
gethin.evans@mmu.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gethin H Evans, PhD
Organizational Affiliation
Manchester Metropolitan University
Official's Role
Study Director
Facility Information:
Facility Name
Manchester Metropolitan University
City
Manchester
ZIP/Postal Code
M1 5GD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lewis R Mattin, MRs
Phone
01612471215
Email
l.mattin@mmu.ac.uk
First Name & Middle Initial & Last Name & Degree
Gethin H Evans, PhD
Phone
01612471208
Email
gethin.evans@mmu.ac.uk
First Name & Middle Initial & Last Name & Degree
Lewis R Mattin, MRs
First Name & Middle Initial & Last Name & Degree
Gethin H Evans, PhD
First Name & Middle Initial & Last Name & Degree
Adora MW Yau, PhD
First Name & Middle Initial & Last Name & Degree
Victoria J McIver, MRs
First Name & Middle Initial & Last Name & Degree
Lewis J James, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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
Citations:
PubMed Identifier
29921786
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.
Results Reference
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PubMed Identifier
31445052
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.
Results Reference
background
PubMed Identifier
30250241
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.
Results Reference
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Does the Timing of When High Intensity Intermittent Exercise is Undertaken Matter?
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