NCT05308381

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 16, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

March 16, 2022

Last Update Submit

March 31, 2023

Conditions

Keywords

High protein breakfastpostprandial glycaemiaAppetiteEnergy balance

Outcome Measures

Primary Outcomes (1)

  • Metabolic health

    Changes in postprandial blood glucose and insulin responses (e.g., area under the curve) post-exercise between trials

    150 minutes

Secondary Outcomes (10)

  • Lipid profile

    150 minutes

  • Gut hormones

    150 minutes

  • Appetite

    30 minutes

  • Visual analogue scale (VAS)

    305 minutes

  • Substrate oxidation

    305 minutes

  • +5 more secondary outcomes

Study Arms (3)

Fasted exercise

EXPERIMENTAL

Fasted prior to exercise

Behavioral: Fasted exercise

High protein breakfast exercise

EXPERIMENTAL

High protein breakfast consumption prior to exercise

Behavioral: High protein breakfast exercise

High carbohydrate breakfast exercise

EXPERIMENTAL

High carbohydrate breakfast consumption prior to exercise

Behavioral: High carbohydrate breakfast exercise

Interventions

Fasted exerciseBEHAVIORAL

Participants will remain fast (Fasted) 2 h prior to 45 min exercise at 65% VO2max.

Fasted exercise

Participants will consume a high protein breakfast (Protein) 2 h prior to 45 min exercise at 65% VO2max.

High protein breakfast exercise

Participants will consume a high carbohydrate breakfast (Carbohydrate) 2 h prior to 45 min exercise at 65% VO2max.

High carbohydrate breakfast exercise

Eligibility Criteria

Age30 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Normal University

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Appetitive Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Yung-Chih Chen, PhD

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yung-Chih Chen, PhD

CONTACT

Chen, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants and Researchers will be blinded to the interventions.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigatior

Study Record Dates

First Submitted

March 16, 2022

First Posted

April 4, 2022

Study Start

March 15, 2022

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

April 4, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations