High-Intensity Interval TrainingNCT04277091
Upper-body High-intensity Interval Training and Mixed Meal Responses
A study testing High-intensity interval training and Moderate-intensity continuos training in people with High-Intensity Interval Training, run by University of Bath at 1 site in United Kingdom.
Trial summary
Cycling and running-based high-intensity interval training are well-established to improve a variety of health outcomes. However, the efficacy of upper-body high-intensity interval training, vital for individuals with lower-body impairments, has yet to be well-characterized. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- High-Intensity Interval Training
- What is being tested?
- High-intensity interval training and Moderate-intensity continuos training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Oct 2019to 1 Jan 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smoker
- No history of cardiovascular, metabolic, or neuromuscular disease
Who cannot join
- Individuals with a nut allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Upper-body High-intensity Interval Exercise vs. Moderate-intensity Continuous Exercise on Postprandial Metabolism
Cycling and running-based high-intensity interval training are well-established to improve a variety of health outcomes. However, the efficacy of upper-body high-intensity interval training, vital for individuals with lower-body impairments, has yet to be well-characterized. The purpose of this study is to compare the effect of a single bout of upper-body high-intensity interval exercise (HIIE) in comparison to traditional moderate-intensity continuous exercise (MICE) on the blood response (e.g. glucose, insulin, fats) following a meal.
This study is recruiting able-bodied adults (aged 18-65 years). Participants will need to attend the laboratory at the University of Bath for two preliminary sessions, and three main study trials.
Read the detailed description
The aim of this research is to determine the metabolic responses to a mixed-meal tolerance test following an acute bout of HIIE and an energy-matched MICE bout in able-bodied persons. The hypothesis is that HIIE and MICE will be more effective at reducing the total triglyceride responses compared to a resting control condition.
Preliminary measurements:
Preliminary testing will include measurements of weight and height. There will also be an assessment of resting metabolic rate and maximal exercise capacity. On a second visit, a HIIE familiarisation session will be performed to determine total energy expenditure of the session. All of the exercise protocols will take place on an arm crank ergometer at the University of Bath.
Main trial days:
Before all main trials, participants will be asked to refrain from performing any strenuous physical activity in the 48-h prior (i.e. day 0 and 1) and consuming alcohol/caffeine in the 24-h prior (i.e. day 1). On day 1, participants will be asked to record/replicate their diet using a weighed food-diary. Participants will be asked perform exercise (HIIE and MICE only) at 18:00 on day 1, having consumed no food (other than plain water) from 14:00. They will be given a standardised dinner to eat at 20:00, and asked to avoid the ingestion of any further food (other than plain water) for the rest of the evening.
On day 2 and upon arrival to the laboratory, a cannula will be inserted into a vein, and a baseline blood sample and expired air sample will be taken. The participant will then be asked to consume a smoothie, consisting of peanut butter, banana, coconut oil, sugar, and chocolate-flavoured whey protein powder. The meal should be consumed within 10 minutes and blood samples will be taken from the cannula at 15, 30, 45 60, and 90 minutes and then at every hour for 5 hours after consumption of the meal to monitor changes in metabolic markers. Expired gas samples will also be taken hourly and indirect calorimetry will be used to estimate relative fat and carbohydrate metabolism in response to the meal.
- Conditions
- High-Intensity Interval Training
- Being tested
- High-intensity interval training, Moderate-intensity continuos training
- Keywords
- postprandial metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingOther
Arm-cranking exercise
Moderate-intensity continuos trainingOther
Arm-cranking exercise
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No exercise |
| High-intensity interval exercise | Experimental | 10 x 60 s intervals at 80% peak power output (interspersed with 60 s recovery intervals at 10% peak power output) Receives: Other: High-intensity interval training |
| Moderate-intensity continous exercise | Experimental | 50% peak power output (duration determined to elicit same energy expenditure as high-intensity interval exercise condition) Receives: Other: Moderate-intensity continuos training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial triglyceride concentrations
Postprandial triglyceride concentrations in serum samples
Measured: 5 hours
Secondary outcomes (8)
Postprandial glucose concentrations
Postprandial glucose concentrations in serum samples
Measured: 5 hours
Postprandial insulin concentrations
Postprandial insulin concentrations in serum samples
Measured: 5 hours
Postprandial substrate oxidation
Postprandial substrate oxidation determined by indirect calorimetry
Measured: 5 hours
Rating of Perceived Exertion
Global, central, and local rating of perceived exertion (6-20) during exercise
Measured: HIIE: End of Warm-Up, 8 min, 12 min, 16 min, 20 min, 24 min. MICE: 0, 20, 40, 60, 80, 100% through exercise session (exact time points dependent on exercise time for each participant)
Heart Rate
Heart rate during exercise
Measured: HIIE: End of Warm-Up, 8 min, 12 min, 16 min, 20 min, 24 min. MICE: 0, 20, 40, 60, 80, 100% through exercise session (exact time points dependent on exercise time for each participant)
Affect
Affect measured through the Feeling Scale (FS) during exercise. FS is a one item scale ranging from +5 ("Very good") to -5 ("Very bad").
Measured: HIIE: End of Warm-Up, 8 min, 12 min, 16 min, 20 min, 24 min. MICE: 0, 20, 40, 60, 80, 100% through exercise session (exact time points dependent on exercise time for each participant)
Exercise Enjoyment
Enjoyment measured by the Physical Activity Enjoyment Scale (PACES). PACES is a 17-item scale, with each item scored from 1 to 7. The total score will be calculated.
Measured: 30 min post-exercise
Self-efficacy
Confidence in ability to perform exercise performed during trial in the next 4 weeks measured using a 5-item scale ranging from 0% ("Not at all" to 100% ("Extremely confident").
Measured: 30 min post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start21 Oct 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Intensity Interval TrainingStudies 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
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Bilzon, University of Bath
- Investigators
- James Bilzon, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277091
- Sponsor's protocol ID
- EP 18/19 087
- Status last verified
- Jul 2022
- First submitted
- 10 Feb 2020
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Upper-body High-intensity Interval Exercise vs. Moderate-intensity Continuous Exercise on Postprandial Metabolism
- ClinicalTrials.gov ID
- NCT04277091
- Acronym / sponsor ID
- EP 18/19 087
- Conditions
- High-Intensity Interval Training
- Keywords
- postprandial metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 20 Feb 2020 (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.
Cycling and running-based high-intensity interval training are well-established to improve a variety of health outcomes. However, the efficacy of upper-body high-intensity interval training, vital for individuals with lower-body impairments, has yet to be well-characterized. The purpose of this study is to compare the effect of a single bout of upper-body high-intensity interval exercise (HIIE) in comparison to traditional moderate-intensity continuous exercise (MICE) on the blood response (e.g. glucose, insulin, fats) following a meal.
This study is recruiting able-bodied adults (aged 18-65 years). Participants will need to attend the laboratory at the University of Bath for two preliminary sessions, and three main study trials.
Detailed description
The aim of this research is to determine the metabolic responses to a mixed-meal tolerance test following an acute bout of HIIE and an energy-matched MICE bout in able-bodied persons. The hypothesis is that HIIE and MICE will be more effective at reducing the total triglyceride responses compared to a resting control condition.
Preliminary measurements:
Preliminary testing will include measurements of weight and height. There will also be an assessment of resting metabolic rate and maximal exercise capacity. On a second visit, a HIIE familiarisation session will be performed to determine total energy expenditure of the session. All of the exercise protocols will take place on an arm crank ergometer at the University of Bath.
Main trial days:
Before all main trials, participants will be asked to refrain from performing any strenuous physical activity in the 48-h prior (i.e. day 0 and 1) and consuming alcohol/caffeine in the 24-h prior (i.e. day 1). On day 1, participants will be asked to record/replicate their diet using a weighed food-diary. Participants will be asked perform exercise (HIIE and MICE only) at 18:00 on day 1, having consumed no food (other than plain water) from 14:00. They will be given a standardised dinner to eat at 20:00, and asked to avoid the ingestion of any further food (other than plain water) for the rest of the evening.
On day 2 and upon arrival to the laboratory, a cannula will be inserted into a vein, and a baseline blood sample and expired air sample will be taken. The participant will then be asked to consume a smoothie, consisting of peanut butter, banana, coconut oil, sugar, and chocolate-flavoured whey protein powder. The meal should be consumed within 10 minutes and blood samples will be taken from the cannula at 15, 30, 45 60, and 90 minutes and then at every hour for 5 hours after consumption of the meal to monitor changes in metabolic markers. Expired gas samples will also be taken hourly and indirect calorimetry will be used to estimate relative fat and carbohydrate metabolism in response to the meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No exercise |
| High-intensity interval exercise | Experimental | Other: High-intensity interval training10 x 60 s intervals at 80% peak power output (interspersed with 60 s recovery intervals at 10% peak power output) |
| Moderate-intensity continous exercise | Experimental | Other: Moderate-intensity continuos training50% peak power output (duration determined to elicit same energy expenditure as high-intensity interval exercise condition) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-smoker
- No history of cardiovascular, metabolic, or neuromuscular disease
Key exclusion criteria (1 listed)
- Individuals with a nut allergy
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 |
|---|---|---|
| High-intensity interval trainingArm-cranking exercise | Other | High-intensity interval exercise |
| Moderate-intensity continuos trainingArm-cranking exercise | Other | Moderate-intensity continous exercise |
Primary outcome
Postprandial triglyceride concentrations
Time frame: 5 hours
Postprandial triglyceride concentrations in serum samples
8 secondary outcomes
Postprandial glucose concentrations
Time frame: 5 hours
Postprandial insulin concentrations
Time frame: 5 hours
Postprandial substrate oxidation
Time frame: 5 hours
Rating of Perceived Exertion
Time frame: HIIE: End of Warm-Up, 8 min, 12 min, 16 min, 20 min, 24 min. MICE: 0, 20, 40, 60, 80, 100% through exercise session (exact time points dependent on exercise time for each participant)
Heart Rate
Time frame: HIIE: End of Warm-Up, 8 min, 12 min, 16 min, 20 min, 24 min. MICE: 0, 20, 40, 60, 80, 100% through exercise session (exact time points dependent on exercise time for each participant)
Affect
Time frame: HIIE: End of Warm-Up, 8 min, 12 min, 16 min, 20 min, 24 min. MICE: 0, 20, 40, 60, 80, 100% through exercise session (exact time points dependent on exercise time for each participant)
Exercise Enjoyment
Time frame: 30 min post-exercise
Self-efficacy
Time frame: 30 min post-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
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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.
James Bilzon principal investigator
University of Bath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training and Moderate-intensity continuos training in people with High-Intensity Interval Training, run by University of Bath 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 27 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial triglyceride concentrations (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2022; AzTrials last refreshed its copy on 31 Oct 2026.