Breakfast, Exercise and Metabolic Health in Healthy Women

March 31, 2023 updated by: Yung-Chih Chen, National Taiwan Normal University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Metabolic health
Time Frame: 150 minutes
Changes in postprandial blood glucose and insulin responses (e.g., area under the curve) post-exercise between trials
150 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Inflammation
Time Frame: 305 minutes
Changes in inflammation biomarkers (e.g., IL-6, IL-10 and IL-1ra, etc.) responses during trials
305 minutes
Appetite
Time Frame: 30 minutes
ad libitum lunch energy intake (i.e., kcal) after OGTT between trials
30 minutes
Visual analogue scale (VAS)
Time Frame: 305 minutes
Changes in VAS from 1-100 mm (e.g., appetite & mood, etc.) between trials
305 minutes
Substrate oxidation
Time Frame: 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.
305 minutes
Blood pressure
Time Frame: 305 minutes
Changes in blood pressure (e.g., systolic and diastolic blood pressure) during trials
305 minutes
Cognition
Time Frame: 305 minutes
Changes in cognitive performance (e.g., reaction time in milliseconds and accuracy in percentage) during trials
305 minutes
Energy intake
Time Frame: 600 minutes
Changes in energy intake (e.g, total calories) using food diary once participants leaving the laboratory until midnight
600 minutes
Physical activity level
Time Frame: 600 minutes
Changes in physical activity level using an accelerometer to record once participants leaving the laboratory until midnight
600 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan Normal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yung-Chih 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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