NCT04483921

Brief Summary

This study will examine race differences in total energy expenditure and respiratory quotient (RQ) during and after exercise, compared to a sedentary control condition, in adolescent girls who are classified as overweight. In addition, subjective appetite and objective energy intake will be measured throughout the assessment periods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 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

July 14, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

3.1 years

First QC Date

July 14, 2020

Last Update Submit

April 1, 2024

Conditions

Keywords

Energy expenditureSubstrate oxidationAppetiteExerciseEnergy intake

Outcome Measures

Primary Outcomes (4)

  • Exercise Day Energy expenditure

    Total energy expenditure and its components (sleeping, wake \[non-exercise\], activity) as measured by the metabolic chamber

    24 hours on Exercise Day

  • Sedentary Day Energy expenditure

    Total energy expenditure and its components (sleeping, wake \[non-exercise\], activity) as measured by the metabolic chamber

    24 hours on Sedentary Day

  • Exercise Day Substrate oxidation

    Non-protein respiratory quotient (i.e., carbohydrate and fat utilization) as measured by the metabolic chamber

    24 hours on Exercise Day

  • Sedentary Day Substrate oxidation

    Non-protein respiratory quotient (i.e., carbohydrate and fat utilization) as measured by the metabolic chamber

    24 hours on Sedentary Day

Secondary Outcomes (4)

  • Exercise Day Appetite

    24 hours on Exercise Day

  • Sedentary Day Appetite

    24 hours on Sedentary Day

  • Exercise Day Energy Intake

    24 hours on Exercise Day

  • Sedentary Day Energy Intake

    24 hours on Sedentary Day

Other Outcomes (8)

  • Dual-energy x-ray absorptiometry (DXA)

    Baseline screening visit

  • Body shape

    Baseline screening visit

  • Cardiorespiratory fitness

    Baseline screening visit

  • +5 more other outcomes

Study Arms (2)

Exercise

EXPERIMENTAL

Participants will complete a prescribed exercise bout.

Other: Acute exercise

Sedentary

NO INTERVENTION

Participants will rest quietly in a seated position for the equivalent amount of time prescribed for the exercise condition.

Interventions

Participants will complete a morning exercise bout at 70% of their individual maximal aerobic capacity to burn 200 kilocalories above their basal metabolic rate.

Exercise

Eligibility Criteria

Age13 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Female
  • Age 13-17 years, inclusive
  • Achieved menarche based on parent- and/or self-report
  • Overweight based on BMI percentile for age and sex (≥ 85th and \< 95th)
  • Self-identification as non-Hispanic White or African-American
  • Willing to maintain current physical activity, sleep schedule, and dietary habits during the study
  • Willing to comply with study procedures

You may not qualify if:

  • Contraindications to exercise testing as defined by the American College of Sports Medicine (i.e., medical history of cardiovascular, pulmonary, or physical conditions that affect the ability to exercise)
  • Food allergies
  • Dietary restrictions
  • Unwilling to consume study foods
  • History of polycystic ovary syndrome (PCOS)
  • Current amenorrhea or other menstrual cycle irregularities
  • Pregnant or currently breastfeeding
  • Current anemia
  • Use of medications affecting metabolism or sleep
  • Inability to properly or safely complete the study procedures per the investigators' discretion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Eric Ravussin, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Within-subjects crossover design. The order of conditions is counterbalanced within each subgroup of participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 23, 2020

Study Start

July 15, 2020

Primary Completion

September 2, 2023

Study Completion

October 20, 2023

Last Updated

April 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

De-identified IPD will be housed indefinitely on secure digital servers as part of the Pennington Biomedical Clinical Database. De-identified IPD may be made available to other researchers upon reasonable request to the Principal Investigator, following Pennington Biomedical's standard procedures for data use agreements and secure data transfers.

Locations