- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05291065
Breakfast, Exercise and Metabolic Health in Healthy Men
April 4, 2023 updated by: Yung-Chih Chen, National Taiwan Normal University
Impact of Different Pre-exercise Breakfast Composition on Post-exercise Glycaemic Response, Appetite and Energy Balance
This project aims to investigate the impact of acute bout of submaximal exercise under different pre-exercise dietary conditions (fasted state versus high carbohydrate breakfast versus high protein breakfast) on postprandial glycaemic, appetite regulation and energy balance.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Participants will be asked to arrive to the laboratory between 08:00 and 9:00 am after not eating for between 12-14 hours i.e. in a fasted state (water intake is permitted and encouraged).
Participants will then be given one of three test drinks (i.e., breakfast): 1) water only; 2) high carbohydrate drink; or 3) high protein (whey protein) drink.
Each of these drinks will also contain 500 mL of water and artificial sweetener.
2 h after breakfast, participants will then exercise on a treadmill for 45 min followed by a 2-h oral glucose tolerance test (OGTT) and 30 min ad libitum lunch intake.
Blood samples, blood pressures and questionnaire (e.g., appetite and mood) will be collected in a regular pattern throughout the trials.
Cognitive functions will be tested at baseline, pre-exercise and 2 h post-exercise.
Energy balance will be assessed using food diary and an accelerometer for the rest of the day after leaving the laboratory until midnight.
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yung-Chih Chen, PhD
- Phone Number: +886277496979
- Email: yc.chen@ntnu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan
- Recruiting
- National Taiwan Normal University
-
Contact:
- Yung-Chih Chen, PhD
- Email: yc.chen@ntnu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy physical active men (self-reported regular exercise at least 30 min moderate-intensity 3 times per week)
- Aged between 30 to 55 years
- Weight stable for more than 3 months (no change in weight +/- 3%)
- Non-smoker
Exclusion Criteria:
- Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
- Taking medications that may influence lipid or carbohydrate metabolism or immune system function
- Women
- Physically inactive
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fasted exercise
Fasted prior to exercise
|
Participants will remain fast (Fasted) 2 h prior to 45 min exercise at 65% VO2max.
|
Experimental: High protein breakfast exercise
High protein breakfast consumption prior to exercise
|
Participants will consume a high protein breakfast (Protein) 2 h prior to 45 min exercise at 65% VO2max.
|
Experimental: High carbohydrate breakfast exercise
High carbohydrate breakfast consumption prior to exercise
|
Participants will consume a high carbohydrate breakfast (Carbohydrate) 2 h prior to 45 min exercise at 65% VO2max.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic health
Time Frame: 150 minutes
|
Changes in blood glycaemic and insulinaemic responses post-exercise between trials
|
150 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lipid profile
Time Frame: 150 minutes
|
Changes in blood triglycerides, cholesterol & NEFA concentrations post-exercise between trials
|
150 minutes
|
Gut hormones
Time Frame: 150 minutes
|
Changes in gut hormones (e.g., GLP-1, PYY and GIP, etc.) responses post-exercise between trials
|
150 minutes
|
Appetite
Time Frame: 30 minutes
|
ad libitum lunch intake after OGTT between trials
|
30 minutes
|
Visual analogue scale (VSA)
Time Frame: 305 minutes
|
Changes in VSA (e.g., appetite & mood, etc) between trials
|
305 minutes
|
Substrate oxidation
Time Frame: 305 minutes
|
Changes in total energy expenditure, lipid oxidation and carbohydrate oxidation between trials
|
305 minutes
|
Inflammation
Time Frame: 305 minutes
|
Changes in inflammation biomarkers (e.g., IL-6, IL-10 and IL-1ra, etc.) responses during trials
|
305 minutes
|
Blood pressure
Time Frame: 305 minutes
|
Changes in blood pressure during trials
|
305 minutes
|
Cognition
Time Frame: 305 minutes
|
Changes in cognitive performance during trials
|
305 minutes
|
Energy balance
Time Frame: 480 minutes
|
Changes in energy intake and physical activity once participants leaving the laboratory until midnight
|
480 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chen, PhD, National Taiwan Normal University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2022
Primary Completion (Anticipated)
January 1, 2024
Study Completion (Anticipated)
January 1, 2024
Study Registration Dates
First Submitted
March 14, 2022
First Submitted That Met QC Criteria
March 14, 2022
First Posted (Actual)
March 22, 2022
Study Record Updates
Last Update Posted (Actual)
April 5, 2023
Last Update Submitted That Met QC Criteria
April 4, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 202012HM031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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