SubsTRate OxidatioN in Girls

Overweight Adolescents Clinical Trial

— STRONG  

Official title:

Race Differences in 24-hour Energy Expenditure, Substrate Oxidation, and Appetite in Adolescent Girls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04483921
• Other study ID #: PBRC 2020-003
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: October 20, 2023

Study information

• Verified date: April 2024
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 20, 2023
• Est. primary completion date: September 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight Adolescents

Intervention

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

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Nutrition Obesity Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dual-energy x-ray absorptiometry (DXA)	Total body composition (fat, muscle, bone tissue) measured by Hologic Discovery DXA	Baseline screening visit
Other	Body shape	3D optical imaging assessment of body shape by Fit3D scanner	Baseline screening visit
Other	Cardiorespiratory fitness	Maximal aerobic capacity assessed by graded cycle ergometer test to volitional fatigue	Baseline screening visit
Other	Resting metabolic rate	Measured over a 30-minute period by ventilated hood and metabolic cart	Baseline screening visit
Other	Implicit activity preferences	Relative preference for physical versus sedentary activities as assessed by a forced-choice behavioral task	Baseline screening visit
Other	Habitual physical activity	Accelerometry measures of usual physical activity before each experimental visit	7 days leading up to Exercise Day and Sedentary Day
Other	Habitual sedentary time	Accelerometry measures of usual sedentary time before each experimental visit	7 days leading up to Exercise Day and Sedentary Day
Other	Habitual food intake	Food intake diary/dietary record to assist participants in maintaining consistent diet before each experimental visit	3 days leading up to Exercise Day and Sedentary Day
Primary	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
Primary	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
Primary	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
Primary	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	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	24 hours on Exercise Day
Secondary	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	24 hours on Sedentary Day
Secondary	Exercise Day Energy Intake	Objectively measured food intake during the metabolic chamber assessments will be converted to energy intake in kilocalories	24 hours on Exercise Day
Secondary	Sedentary Day Energy Intake	Objectively measured food intake during the metabolic chamber assessments will be converted to energy intake in kilocalories	24 hours on Sedentary Day