Clinical trial NCT04483921: SubsTRate OxidatioN in Girls
Official title: Race Differences in 24-hour Energy Expenditure, Substrate Oxidation, and Appetite in Adolescent Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight Adolescents
Keywords: Energy expenditure
Substrate oxidation
Appetite
Exercise
Energy intake
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Nutrition Obesity Research Center
First posted: 2020-07-23
Enrollment: 14
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within-subjects crossover design. The order of conditions is counterbalanced within each subgroup of participants.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Exercise Day Energy expenditure
timeFrame: 24 hours on Exercise Day
measure: Sedentary Day Energy expenditure
timeFrame: 24 hours on Sedentary Day
measure: Exercise Day Substrate oxidation
timeFrame: 24 hours on Exercise Day
measure: Sedentary Day Substrate oxidation
timeFrame: 24 hours on Sedentary Day
Secondary outcomes:
measure: Exercise Day Appetite
timeFrame: 24 hours on Exercise Day
measure: Sedentary Day Appetite
timeFrame: 24 hours on Sedentary Day
measure: Exercise Day Energy Intake
timeFrame: 24 hours on Exercise Day
measure: Sedentary Day Energy Intake
timeFrame: 24 hours on Sedentary Day
Other outcomes:
measure: Dual-energy x-ray absorptiometry (DXA)
timeFrame: Baseline screening visit
measure: Body shape
timeFrame: Baseline screening visit
measure: Cardiorespiratory fitness
timeFrame: Baseline screening visit
measure: Resting metabolic rate
timeFrame: Baseline screening visit
measure: Implicit activity preferences
timeFrame: Baseline screening visit
measure: Habitual physical activity
timeFrame: 7 days leading up to Exercise Day and Sedentary Day
measure: Habitual sedentary time
timeFrame: 7 days leading up to Exercise Day and Sedentary Day
measure: Habitual food intake
timeFrame: 3 days leading up to Exercise Day and Sedentary Day
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Professor
name: Eric Ravussin, PhD
role: PRINCIPAL_INVESTIGATOR
References: