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SubsTRate OxidatioN in Girls (STRONG)

Primary Purpose

Overweight Adolescents

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acute exercise
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight Adolescents focused on measuring Energy expenditure, Substrate oxidation, Appetite, Exercise, Energy intake

Eligibility Criteria

13 Years - 17 Years (Child)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Pennington Biomedical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Sedentary

Arm Description

Participants will complete a prescribed exercise bout.

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

Outcomes

Primary Outcome Measures

Exercise Day Energy expenditure
Total energy expenditure and its components (sleeping, wake [non-exercise], activity) as measured by the metabolic chamber
Sedentary Day Energy expenditure
Total energy expenditure and its components (sleeping, wake [non-exercise], activity) as measured by the metabolic chamber
Exercise Day Substrate oxidation
Non-protein respiratory quotient (i.e., carbohydrate and fat utilization) as measured by the metabolic chamber
Sedentary Day Substrate oxidation
Non-protein respiratory quotient (i.e., carbohydrate and fat utilization) as measured by the metabolic chamber

Secondary Outcome Measures

Exercise Day Appetite
Overall subjective appetite and its components (hunger, fullness, desire to eat, prospective food consumption, satisfaction, food wanting) assessed by visual analog scales (0-100 mm) during the metabolic chamber assessments
Sedentary Day Appetite
Overall subjective appetite and its components (hunger, fullness, desire to eat, prospective food consumption, satisfaction, food wanting) assessed by visual analog scales (0-100 mm) during the metabolic chamber assessments
Exercise Day Energy Intake
Objectively measured food intake during the metabolic chamber assessments will be converted to energy intake in kilocalories
Sedentary Day Energy Intake
Objectively measured food intake during the metabolic chamber assessments will be converted to energy intake in kilocalories

Full Information

First Posted
July 14, 2020
Last Updated
May 5, 2023
Sponsor
Pennington Biomedical Research Center
Collaborators
Nutrition Obesity Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT04483921
Brief Title
SubsTRate OxidatioN in Girls
Acronym
STRONG
Official Title
Race Differences in 24-hour Energy Expenditure, Substrate Oxidation, and Appetite in Adolescent Girls
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
Nutrition Obesity Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Aim 1: Measure 24-hour energy expenditure and its components (resting, activity, and sleep energy expenditure) and compare differences between African-American and White girls. Hypothesis: Total, resting, and sleep energy expenditure will be lower in African-American relative to White girls. Activity energy expenditure will be equivalent per the study design. Aim 2: Measure and compare substrate oxidation and associations with appetite (i.e., hunger, desire to eat) and energy intake between African-American and White girls. Hypothesis: African-American girls will have a higher RQ at rest, during exercise, and following exercise, and RQ will be positively associated with subjective appetite ratings and energy intake.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight Adolescents
Keywords
Energy expenditure, Substrate oxidation, Appetite, Exercise, Energy intake

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Within-subjects crossover design. The order of conditions is counterbalanced within each subgroup of participants.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Participants will complete a prescribed exercise bout.
Arm Title
Sedentary
Arm Type
No Intervention
Arm Description
Participants will rest quietly in a seated position for the equivalent amount of time prescribed for the exercise condition.
Intervention Type
Other
Intervention Name(s)
Acute exercise
Intervention Description
Participants will complete a morning exercise bout at 70% of their individual maximal aerobic capacity to burn 200 kilocalories above their basal metabolic rate.
Primary Outcome Measure Information:
Title
Exercise Day Energy expenditure
Description
Total energy expenditure and its components (sleeping, wake [non-exercise], activity) as measured by the metabolic chamber
Time Frame
24 hours on Exercise Day
Title
Sedentary Day Energy expenditure
Description
Total energy expenditure and its components (sleeping, wake [non-exercise], activity) as measured by the metabolic chamber
Time Frame
24 hours on Sedentary Day
Title
Exercise Day Substrate oxidation
Description
Non-protein respiratory quotient (i.e., carbohydrate and fat utilization) as measured by the metabolic chamber
Time Frame
24 hours on Exercise Day
Title
Sedentary Day Substrate oxidation
Description
Non-protein respiratory quotient (i.e., carbohydrate and fat utilization) as measured by the metabolic chamber
Time Frame
24 hours on Sedentary Day
Secondary Outcome Measure Information:
Title
Exercise Day Appetite
Description
Overall subjective appetite and its components (hunger, fullness, desire to eat, prospective food consumption, satisfaction, food wanting) assessed by visual analog scales (0-100 mm) during the metabolic chamber assessments
Time Frame
24 hours on Exercise Day
Title
Sedentary Day Appetite
Description
Overall subjective appetite and its components (hunger, fullness, desire to eat, prospective food consumption, satisfaction, food wanting) assessed by visual analog scales (0-100 mm) during the metabolic chamber assessments
Time Frame
24 hours on Sedentary Day
Title
Exercise Day Energy Intake
Description
Objectively measured food intake during the metabolic chamber assessments will be converted to energy intake in kilocalories
Time Frame
24 hours on Exercise Day
Title
Sedentary Day Energy Intake
Description
Objectively measured food intake during the metabolic chamber assessments will be converted to energy intake in kilocalories
Time Frame
24 hours on Sedentary Day
Other Pre-specified Outcome Measures:
Title
Dual-energy x-ray absorptiometry (DXA)
Description
Total body composition (fat, muscle, bone tissue) measured by Hologic Discovery DXA
Time Frame
Baseline screening visit
Title
Body shape
Description
3D optical imaging assessment of body shape by Fit3D scanner
Time Frame
Baseline screening visit
Title
Cardiorespiratory fitness
Description
Maximal aerobic capacity assessed by graded cycle ergometer test to volitional fatigue
Time Frame
Baseline screening visit
Title
Resting metabolic rate
Description
Measured over a 30-minute period by ventilated hood and metabolic cart
Time Frame
Baseline screening visit
Title
Implicit activity preferences
Description
Relative preference for physical versus sedentary activities as assessed by a forced-choice behavioral task
Time Frame
Baseline screening visit
Title
Habitual physical activity
Description
Accelerometry measures of usual physical activity before each experimental visit
Time Frame
7 days leading up to Exercise Day and Sedentary Day
Title
Habitual sedentary time
Description
Accelerometry measures of usual sedentary time before each experimental visit
Time Frame
7 days leading up to Exercise Day and Sedentary Day
Title
Habitual food intake
Description
Food intake diary/dietary record to assist participants in maintaining consistent diet before each experimental visit
Time Frame
3 days leading up to Exercise Day and Sedentary Day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Ravussin, PhD
Phone
2257633186
Email
eric.ravussin@pbrc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Fearnbach, PhD
Phone
2257632612
Email
nicole.fearnbach@pbrc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Ravussin, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Ravussin, PhD
Phone
225-763-3186
Email
eric.ravussin@pbrc.edu
First Name & Middle Initial & Last Name & Degree
Nicole Fearnbach, PhD
Phone
2257632612
Email
nicole.fearnbach@pbrc.edu
First Name & Middle Initial & Last Name & Degree
Nicole Fearnbach, PhD
First Name & Middle Initial & Last Name & Degree
Leanne Redman, PhD
First Name & Middle Initial & Last Name & Degree
Peter Katzmarzyk, PhD
First Name & Middle Initial & Last Name & Degree
Daniel Hsia, MD
First Name & Middle Initial & Last Name & Degree
Neil Johannsen, PhD
First Name & Middle Initial & Last Name & Degree
Heather Allaway, PhD
First Name & Middle Initial & Last Name & Degree
Eric Ravussin, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

SubsTRate OxidatioN in Girls

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