Breakfast, Exercise and Metabolic Health in Healthy Women

Not Applicable

Recruiting

• Conditions: Appetitive Behavior; Energy Balance; Metabolic Health
• Interventions: Behavioral: Fasted exercise; Behavioral: High protein breakfast exercise; Behavioral: High carbohydrate breakfast exercise

• Registration Number: NCT05308381
• Lead Sponsor: National Taiwan Normal University

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 in active healthy women.

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 Timeline

• Study Start: 2022-03-15
• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-25
• Study First Posted: 2022-04-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-04
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fasted exercise	Fasted exercise	Fasted prior to exercise
High protein breakfast exercise	High protein breakfast exercise	High protein breakfast consumption prior to exercise
High carbohydrate breakfast exercise	High carbohydrate breakfast exercise	High carbohydrate breakfast consumption prior to exercise

Primary Outcome Measures

Name	Time	Method
Metabolic health	150 minutes	Changes in postprandial blood glucose and insulin responses (e.g., area under the curve) post-exercise between trials

Secondary Outcome Measures

Name	Time	Method
Gut hormones	150 minutes	Changes in gut hormones (e.g., GLP-1, PYY and GIP, etc.) responses post-exercise between trials
Lipid profile	150 minutes	Changes in blood triglycerides, cholesterol \& NEFA concentrations post-exercise between trials
Appetite	30 minutes	ad libitum lunch energy intake (i.e., kcal) after OGTT between trials
Visual analogue scale (VAS)	305 minutes	Changes in VAS from 1-100 mm (e.g., appetite \& mood, etc.) between trials
Blood pressure	305 minutes	Changes in blood pressure (e.g., systolic and diastolic blood pressure) during trials
Substrate oxidation	305 minutes	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.
Inflammation	305 minutes	Changes in inflammation biomarkers (e.g., IL-6, IL-10 and IL-1ra, etc.) responses during trials
Energy intake	600 minutes	Changes in energy intake (e.g, total calories) using food diary once participants leaving the laboratory until midnight
Cognition	305 minutes	Changes in cognitive performance (e.g., reaction time in milliseconds and accuracy in percentage) during trials
Physical activity level	600 minutes	Changes in physical activity level using an accelerometer to record once participants leaving the laboratory until midnight

Trial Locations

Locations (1)

National Taiwan Normal University; 🇨🇳 Taipei, Taiwan