Breakfast, Exercise and Metabolic Health in Healthy Women

Appetitive Behavior Clinical Trial

Official title:

Impact of Different Pre-exercise Breakfast on Post-exercise Glycaemic Response, Appetite and Energy Balance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05308381
• Other study ID #: 202012HM031-
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2023
• Source: National Taiwan Normal University
• Contact: Yung-Chih Chen, PhD
• Phone: +886277496979
• Email: yc.chen[@]ntnu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 in active healthy women.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy physical active women (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

• Men

• Physically inactive

Related Conditions & MeSH terms

• Appetitive Behavior
• Energy Balance
• Metabolic Health

Intervention

Behavioral:
• Fasted exercise
Participants will remain fast (Fasted) 2 h prior to 45 min exercise at 65% VO2max.
• High protein breakfast exercise
Participants will consume a high protein breakfast (Protein) 2 h prior to 45 min exercise at 65% VO2max.
• High carbohydrate breakfast exercise
Participants will consume a high carbohydrate breakfast (Carbohydrate) 2 h prior to 45 min exercise at 65% VO2max.

Locations

Country	Name	City	State
Taiwan	National Taiwan Normal University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan Normal University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic health	Changes in postprandial blood glucose and insulin responses (e.g., area under the curve) post-exercise between trials	150 minutes
Secondary	Lipid profile	Changes in blood triglycerides, cholesterol & NEFA concentrations post-exercise between trials	150 minutes
Secondary	Gut hormones	Changes in gut hormones (e.g., GLP-1, PYY and GIP, etc.) responses post-exercise between trials	150 minutes
Secondary	Appetite	ad libitum lunch energy intake (i.e., kcal) after OGTT between trials	30 minutes
Secondary	Visual analogue scale (VAS)	Changes in VAS from 1-100 mm (e.g., appetite & mood, etc.) between trials	305 minutes
Secondary	Substrate oxidation	Changes in total energy expenditure (i.e., kcal), lipid oxidation (i.e., kcal) and carbohydrate oxidation (i.e., kcal) between trials including pre-exercise, during exercise and post-exercise period.	305 minutes
Secondary	Inflammation	Changes in inflammation biomarkers (e.g., IL-6, IL-10 and IL-1ra, etc.) responses during trials	305 minutes
Secondary	Blood pressure	Changes in blood pressure (e.g., systolic and diastolic blood pressure) during trials	305 minutes
Secondary	Cognition	Changes in cognitive performance (e.g., reaction time in milliseconds and accuracy in percentage) during trials	305 minutes
Secondary	Energy intake	Changes in energy intake (e.g, total calories) using food diary once participants leaving the laboratory until midnight	600 minutes
Secondary	Physical activity level	Changes in physical activity level using an accelerometer to record once participants leaving the laboratory until midnight	600 minutes