NCT06033898

Brief Summary

The purpose of the study is to investigate the effect of different periods of physical inactivity on postprandial lipid metabolism in the morning after exercise by measuring plasma triglyceride levels and fat oxidation (burning). The study is a crossover intervention with all healthy participants performing three trials varying in length of physical inactive (12 hours, 24 hours, and 36 hours). All trials include a physical activity control phase (\>10,000 steps/24hr), a physical inactive phase (\<1,000 - 1,500 steps/12hr), a moderate intensity cycling session, and a high-fat tolerance test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2024

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

September 5, 2023

Last Update Submit

February 26, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Fat oxidation (fat burning)

    Exhaled gas will be collected during the high fat tolerance test. Fat oxidation will be calculated based on the gas volume and CO2 and O2 proportion.

    A total of 5 measurements will be done, specifically are before the high fat meal (baseline) and each hour after the high fat meal for 4 hours. The whole test takes about 5 hours from 9 am to 2 pm on the last day of each trial.

  • Plasma triglyceride

    Fingertip blood will be collected during the high fat tolerance test.

    A total of 5 measurements will be done, specifically are before the high fat meal (baseline) and each hour after the high fat meal for 4 hours. The whole test takes about 5 hours from 9 am to 2 pm on the last day of each trial.

Study Arms (3)

12-hr trial

EXPERIMENTAL

Participants will go through a 48-hr physical activity control phase with 10,000 steps taken every 24 hours (9 pm to 9 pm the next day). This phase will be followed with a 12-hour physical inactive phase (9 pm to 9 am the next morning). Less than 1,000 steps during this 12 hours (mostly night time) will be required. The 1-hr cycling session will take place from 8 pm to 9 pm the same day when inactive phase starts. A high fat tolerance test that lasts 5 hours will take place at 9 am the last day.

Behavioral: 12 hours of physical inactivity

24-hr trial

EXPERIMENTAL

Participants will go through a 48-hr physical activity control phase with 10,000 steps taken every 24 hours (9 am to 9 am the next morning). This phase will be followed with a 24-hour physical inactive phase (9 am to 9 am the next morning). During this 24 hours, from 9 am to 9 pm (mostly daytime), less than 1,500 steps is required, and from 9 pm to 9 am the next morning (mostly night), less than 1,000 steps is required. The 1-hr cycling session will take place from 8 pm to 9 pm on the day when inactive phase starts. A high fat tolerance test that lasts 5 hours will take place at 9 am the last day.

Behavioral: 24 hours of physical inactivity

36-hr trial

EXPERIMENTAL

Participants will go through a 48-hr physical activity control phase with 10,000 steps taken every 24 hours (9 pm to 9 pm the next day). This phase will be followed with a 36-hour physical inactive phase (9 pm - 9 am on the high fat tolerance day). During the inactive phase, it includes two 12 hours that mostly at night (9 pm - 9 am the next day) and one 12 hours (9 am to 9 pm the same day) that mostly in the day. Less than 1,500 steps is required for 9 pm - 9 am periods, and less than 1,000 steps is needed for 9 am - 9 pm (same day) phase. The 1-hr cycling session will take place from 8 pm to 9 pm the second last day in the trial. A high fat tolerance test that lasts 5 hours will take place at 9 am the last day.

Behavioral: 36 hours of physical inactivity

Interventions

A pedometer will be worn by participants during the whole trial. Steps will be monitored. Participants will be required to reach 10,000 steps per 24 hours for 48 hours, and then limit their steps below 1000 steps. A diet record form, a sleep record, and a step record form will be given to participants to log in their diet, sleep time and steps taken through out the whole trial. Participant will be asks to mimic the diet between trials.

12-hr trial

A pedometer will be worn by participants during the whole trial. Steps will be monitored. Participants will be required to reach 10,000 steps per 24 hours for 48 hours, and then limit their steps below 1,000 - 1,500 steps per 12 hours for 24 hours. A diet record form, a sleep record, and a step record form will be given to participants to log in their diet, sleep time and steps taken through out the whole trial. Participant will be asks to mimic the diet between trials.

24-hr trial

A pedometer will be worn by participants during the whole trial. Steps will be monitored. Participants will be required to reach 10,000 steps per 24 hours for 48 hours, and then limit their steps below 1,000 - 1,500 steps per 12 hours for 36 hours. A diet record form, a sleep record, and a step record form will be given to participants to log in their diet, sleep time and steps taken through out the whole trial. Participant will be asks to mimic the diet between trials.

36-hr trial

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or female between the age of 18-65 years old
  • Untrained or recreationally active
  • No metabolic disease, no lactose intolerance, not taking medicines altering lipid or carbohydrate metabolism
  • No injury or disease affecting the cycling ability.

You may not qualify if:

  • On medications that alter lipid or carbohydrate metabolism
  • lactose intolerant
  • General health problems: Heart problems or coronary artery disease, hypertension, lung or respiratory problems.
  • Exercise problems: Chest pain, fainting, palpitations, told to give up sports because of health problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

Study Officials

  • Jieting Wang, M.S.

    The University of Texas of Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 13, 2023

Study Start

October 1, 2023

Primary Completion

May 12, 2024

Study Completion

May 12, 2024

Last Updated

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations