Clinical trial NCT05291065: Breakfast, Exercise and Metabolic Health in Healthy Men
Official title: Impact of Different Pre-exercise Breakfast Composition on Post-exercise Glycaemic Response, Appetite and Energy Balance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Health
Appetitive Behavior
Energy Balance
Keywords: High protein breakfast
postprandial glycaemia
Appetite
Energy balance
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 12
Sex: MALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metabolic health
timeFrame: 150 minutes
Secondary outcomes:
measure: Lipid profile
timeFrame: 150 minutes
measure: Gut hormones
timeFrame: 150 minutes
measure: Appetite
timeFrame: 30 minutes
measure: Visual analogue scale (VSA)
timeFrame: 305 minutes
measure: Substrate oxidation
timeFrame: 305 minutes
measure: Inflammation
timeFrame: 305 minutes
measure: Blood pressure
timeFrame: 305 minutes
measure: Cognition
timeFrame: 305 minutes
measure: Energy balance
timeFrame: 480 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Normal University
Study officials:
affiliation: National Taiwan Normal University
name: Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: