Breakfast, Exercise and Metabolic Health in Healthy Women

Impact of Different Pre-exercise Breakfast 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 in active healthy women.

Study Overview

• Status: Recruiting
• Conditions: Appetitive Behavior; Energy Balance; Metabolic Health
• Intervention / Treatment: Behavioral: Fasted exercise; Behavioral: High protein breakfast exercise; Behavioral: High carbohydrate breakfast exercise

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

• Study Contact: Name: Yung-Chih Chen, PhD; Phone Number: +886277496979; Email: yc.chen@ntnu.edu.tw
• Study Contact Backup: Name: Chen, PhD; Email: yc.chen@ntnu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan Normal University
    • Contact: Yung-Chih Chen, PhD; Email: yc.chen@ntnu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fasted exercise; Fasted prior to exercise	Behavioral: Fasted 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	Behavioral: High protein breakfast 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	Behavioral: High carbohydrate breakfast 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	Changes in postprandial blood glucose and insulin responses (e.g., area under the curve) post-exercise between trials	150 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan Normal University
• Investigators: Principal Investigator: Yung-Chih Chen, PhD, National Taiwan Normal University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Appetite; Energy balance; postprandial glycaemia; High protein breakfast
• 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