NCT06407050

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 (4 hours, 8 hours, and 12 hours). All trials include a physical activity control phase (\>8,500 steps/24hr), a physical inactive phase, 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 Apr 2024

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

Study Start

First participant enrolled

April 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

May 6, 2024

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.

    Through study completion, around 9 months

  • Plasma triglyceride

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

    Through study completion, around 9 months

Study Arms (3)

4-hr trial

EXPERIMENTAL

Participants will go through a day of routine step counts and sleep hour monitor, 2 days of being physical active by taking ambulatory steps, 4 hours of physical inactivity intervention, and moderate intensity cycling, and 1 high fat tolerance test.

Behavioral: 4 hours of physical inactivity

8-hr Trial

EXPERIMENTAL

Participants will go through a day of routine step counts and sleep hour monitor, 2 days of being physical active by taking ambulatory steps, 8 hours of physical inactivity intervention, and moderate intensity cycling, and 1 high fat tolerance test.

Behavioral: 8 hours of physical inactivity

12-hr Trial

EXPERIMENTAL

Participants will go through a day of routine step counts and sleep hour monitor, 2 days of being physical active by taking ambulatory steps, 12 hours of physical inactivity intervention, and moderate intensity cycling, and 1 high fat tolerance test.

Behavioral: 12 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 8,500 steps per day for the first 2 days. On the third day participants need to take 600 steps hourly for 8 hours from 7 am to 3 pm and another 2,000 steps between 3:40 pm to 4 pm. Participant will then stay inactive from 4 pm to 8 pm and do a cycling for one hour in the lab. During the inactivity period, participants will remain seated and steps are only allowed for food, water, and bathroom use. A 3 day food log will be given to participants to log in their diet. Participant will be asks to mimic the diet between trials. A Fitbit will be worn by participants to record the sleep hours during the trial.

4-hr trial

A pedometer will be worn by participants during the whole trial. Steps will be monitored. Participants will be required to reach 8,500 steps per day for the first 2 days. On the third day participants need to take 600 steps hourly for 4 hours from 7 am to 11 am and then 2,000 steps between 11:40 am to 12 pm. During the inactivity period, participants will remain seated and steps are only allowed for food, water, and bathroom use. Participant will then stay inactive from 12 pm to 8 pm and do a cycling for one hour in the lab. A 3 day food log will be given to participants to log in their diet. Participant will be asks to mimic the diet between trials. A Fitbit will be worn by participants to record the sleep hours during the trial.

8-hr Trial

A pedometer will be worn by participants during the whole trial. Steps will be monitored. Participants will be required to reach 8,500 steps per day for the first 2 days. On the third day, participant will take 2,000 steps between 7:40 am to 8 am and then stay inactive from 8 am to 8 pm. During the inactivity period, participants will remain seated and steps are only allowed for food, water, and bathroom use. Right after the inactivity intervention, participant will do a 1-hr cycling in lab. A 3 day food log will be given to participants to log in their diet. Participant will be asks to mimic the diet between trials. A Fitbit will be worn by participants to record the sleep hours during the trial.

12-hr Trial

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female between the age of 18-40 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

Related Publications (1)

  • Coyle EF, Burton HM, Satiroglu R. Inactivity Causes Resistance to Improvements in Metabolism After Exercise. Exerc Sport Sci Rev. 2022 Apr 1;50(2):81-88. doi: 10.1249/JES.0000000000000280.

    PMID: 35025844BACKGROUND

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

May 6, 2024

First Posted

May 9, 2024

Study Start

April 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations