Body Composition Clinical Trial
Official title:
Breakfast, Energy Metabolism, and Skeletal Muscle Health in Obese Children
NCT number | NCT03602144 |
Other study ID # | BEMS1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 21, 2018 |
Est. completion date | August 31, 2020 |
Verified date | February 2021 |
Source | University of Arkansas, Fayetteville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
One in every three children ages 2-19 years is overweight or obese. Although multifactorial in nature, obesity is primarily attributed to a mismatch between energy intake and energy expenditure (EE). Daily EE (DEE) can be partitioned between resting metabolic rate (RMR), EE associated with physical activity, and the thermic effect of food (TEF). RMR corresponds to the energy needed to sustain the body functions at rest and is also related to body composition (i.e., ratio of skeletal muscle mass to fat mass). Skeletal muscle mass is a large contributor to RMR; the more skeletal muscle mass, the higher the RMR (i.e., more energy expended at rest). In addition, muscle plays a central role in whole body protein metabolism and disrupted muscle metabolism is associated with the development of many common chronic diseases associated with obesity such as type 2 diabetes and cardiovascular disease. Although the contribution of disrupted muscle metabolism to chronic disease is well-established in older adults, the potential impact in children is unknown. The overall objective for this primary project application is to determine the role of breakfast protein consumption in improving energy metabolism, energy balance and skeletal muscle health in obese, school-aged children.
Status | Completed |
Enrollment | 88 |
Est. completion date | August 31, 2020 |
Est. primary completion date | September 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 14 Years |
Eligibility | Inclusion Criteria: - Resides within Northwest Arkansas - Age 8-12 years old - BMI >5th percentile - All ethnicities Exclusion Criteria: - Food allergies - Dietary restrictions - Regularly skip breakfast (> 5 times per week) - Prescription medications - Claustrophobic - Fear of needles - Classified as a picky eater by parent/guardian |
Country | Name | City | State |
---|---|---|---|
United States | University of Arkansas | Fayetteville | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas, Fayetteville | University of Arkansas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Whole body energy expenditure (WBEE) | WBEE will be measured using doubly labeled water. | WBEE will be measured as the change between WBEE during day 1 and day 42 of the intervention. | |
Secondary | Appetite (VAS) | Appetite response to test beverages will be measured using visual analog scales. Appetite and palatability were assessed using a traditional 100-mm visual analog scale (VAS) [33] with opposing anchors (e.g., "extremely hungry" or "not hungry at all") at time points 0, 15, 30, 60, 90, and 120 min. Questions consisted of: "how hungry do you feel at this moment", "how full do you feel at this moment", "how strong is your desire to eat this moment" and "how much food do you think you can eat at this moment". A higher number is associated with increased hunger. | VAS will be measured on day 1 and day 42. | |
Secondary | Glycemic Response | Glucose and insulin will be measured using commercially available kits. | Glycemic response will be measured on day 1 and day 42. | |
Secondary | Muscle mass | Muscle mass will be measured using stable isotope-labeled creatine. | Change in muscle mass will be determined by the difference in muscle mass between day 1 and day 42. | |
Secondary | Muscle fractional synthesis rate (FSR) | FSR will be measured using deuterated water and markers of muscle health in plasma. | FSR will be determined as the change between baseline (day 0) and day 42. | |
Secondary | Whole body protein turnover (WPT) | WPT will be measured via stable isotope-labeled nitrogen. | Change in WPT will be determined by the difference in WPT between day 1 and day 42. | |
Secondary | Resting energy expenditure (REE) | REE will be measured using indirect calorimetry. | Change in REE will be determined by the difference in REE between day 1 and day 42. | |
Secondary | Body composition | Body composition will be measured via dual x-ray absorptiometry. | Change in body composition will be determined by the difference in body composition between day 1 and day 42. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05512559 -
Body Composition Analysis and Time to Emergence From Remimazolam
|
||
Enrolling by invitation |
NCT05515835 -
Relationship Between Effect Duration of Rocuronium and Body Composition Analysis Data.
|
||
Completed |
NCT04136821 -
The Long-term Effects of Oceanix™ on Resistance Training Adaptations
|
N/A | |
Completed |
NCT03432130 -
Injury Occurrence in Hip-hop Dance
|
N/A | |
Completed |
NCT04504799 -
Validation of the New HAG-B19 Scale for Measuring Lean and Fat Body Masse
|
||
Withdrawn |
NCT04021446 -
A Supervised Clinic-to-Community Exercise Intervention to Improve Cardiometabolic Health in Survivors of AYA Cancer
|
N/A | |
Completed |
NCT03412578 -
Effect of Tactile/Kinaesthetic Massage Therapy on DXA Parameter of Preterm Infants
|
N/A | |
Completed |
NCT02211612 -
Overeating Different Fats and Influence on Muscle Mass and Body Fat Accumulation
|
N/A | |
Completed |
NCT02000492 -
Frequent Ballgames Training for 9-11 Year Old Schoolchildren
|
N/A | |
Completed |
NCT01209936 -
Hydration Factor Study for the Stayhealthy BC3
|
N/A | |
Recruiting |
NCT06061315 -
Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men
|
N/A | |
Completed |
NCT05730660 -
Quercetin Phytosome® Chronic Fatigue Syndrome
|
N/A | |
Recruiting |
NCT04969588 -
Kinect Equations for Body Indices and Body Composition
|
||
Completed |
NCT04828655 -
Analysis of Bioparametric Measures for Correlating Daily Habits and Reducing Blood Pressure
|
N/A | |
Completed |
NCT04404413 -
High-Intensity Interval Training and Intermittent Fasting on Body Composition and Physical Performance in Active Women
|
N/A | |
Completed |
NCT05052164 -
Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women
|
N/A | |
Completed |
NCT03352583 -
Effects of Casein Timing on Body Composition and Performance
|
N/A | |
Enrolling by invitation |
NCT03587233 -
Are Women With Higher Professional Status More Sedentary Compared to Men?
|
N/A | |
Recruiting |
NCT05556239 -
STAY-STRONG Study of Exercise Training During Chemotherapy
|
N/A | |
Active, not recruiting |
NCT04306523 -
Early Genetic and Environmental Influences on Eating - The Baylor Infant Twins Study
|