- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04277091
Upper-body High-intensity Interval Training and Mixed Meal Responses
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bath, United Kingdom, BA2 7AY
- Department for Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Non-smoker
- No history of cardiovascular, metabolic, or neuromuscular disease
Exclusion Criteria:
- Individuals with a nut allergy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No exercise
|
|
Experimental: High-intensity interval exercise
10 x 60 s intervals at 80% peak power output (interspersed with 60 s recovery intervals at 10% peak power output)
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Arm-cranking exercise
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Experimental: Moderate-intensity continous exercise
50% peak power output (duration determined to elicit same energy expenditure as high-intensity interval exercise condition)
|
Arm-cranking exercise
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial triglyceride concentrations
Time Frame: 5 hours
|
Postprandial triglyceride concentrations in serum samples
|
5 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial glucose concentrations
Time Frame: 5 hours
|
Postprandial glucose concentrations in serum samples
|
5 hours
|
Postprandial insulin concentrations
Time Frame: 5 hours
|
Postprandial insulin concentrations in serum samples
|
5 hours
|
Postprandial substrate oxidation
Time Frame: 5 hours
|
Postprandial substrate oxidation determined by indirect calorimetry
|
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)
|
Global, central, and local rating of perceived exertion (6-20) during exercise
|
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)
|
Heart rate during exercise
|
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)
|
Affect measured through the Feeling Scale (FS) during exercise.
FS is a one item scale ranging from +5 ("Very good") to -5 ("Very bad").
|
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
|
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.
|
30 min post-exercise
|
Self-efficacy
Time Frame: 30 min post-exercise
|
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").
|
30 min post-exercise
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Bilzon, University of Bath
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EP 18/19 087
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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