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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04277091
Other study ID # EP 18/19 087
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 21, 2019
Est. completion date January 1, 2021

Study information

Verified date July 2022
Source University of Bath
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date January 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Non-smoker - No history of cardiovascular, metabolic, or neuromuscular disease Exclusion Criteria: - Individuals with a nut allergy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
High-intensity interval training
Arm-cranking exercise
Moderate-intensity continuos training
Arm-cranking exercise

Locations

Country Name City State
United Kingdom Department for Health Bath

Sponsors (1)

Lead Sponsor Collaborator
University of Bath

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postprandial triglyceride concentrations Postprandial triglyceride concentrations in serum samples 5 hours
Secondary Postprandial glucose concentrations Postprandial glucose concentrations in serum samples 5 hours
Secondary Postprandial insulin concentrations Postprandial insulin concentrations in serum samples 5 hours
Secondary Postprandial substrate oxidation Postprandial substrate oxidation determined by indirect calorimetry 5 hours
Secondary Rating of Perceived Exertion 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)
Secondary Heart Rate 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)
Secondary 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"). 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)
Secondary 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. 30 min post-exercise
Secondary 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"). 30 min post-exercise
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