The Interaction of Body Composition, Sex Hormones and Exercise in Men
- Conditions
- Normal-weight Obesity
- Registration Number
- NCT06970457
- Lead Sponsor
- Oklahoma State University
- Brief Summary
The overall objective of this project is to advance understanding of the causes of normal weight obesity (NWO) in men, namely the hormone profile and related potential mediating mechanisms, and the efficacy of different modes of exercise to restore body composition and cardiometabolic health in this population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 96
- Biological male
- BMI 18.5 - 24.9 kg/m2 or >/= 30 kg/m2
- Body fat <20% or >/= 25%
- Ability and willingness to engage in an exercise training regimen
- Presence of a chronic health condition, or regular use of associate prescribed medications, that would substantially impact study variables
- Excessive alcohol use or use of tobacco products, vape products, or illicit drugs
- Presence of an electrical implant, such as a pacemaker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Luteinizing Hormone Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Luteinizing Hormone (LH), measured in serum via Invitrogen™ Luteinizing Hormone Human ELISA Kit; measured in pg/mL
FSH Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Follicle Stimulating Hormone (FSH), measured in serum via Invitrogen™ Human FSH ELISA Kit; measured in pg/mL
Adiponectin Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Adiponectin, measured in serum via Invitrogen™ Adiponectin Human ELISA Kit; measured in pg/mL
Leptin Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Leptin, measured in serum via Invitrogen™ Leptin Human ELISA Kit; measured in pg/mL
Total Cholesterol Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Total Cholesterol, measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in mg/dL
Lean mass Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Lean mass, measured in kg and as a percentage of total body mass Measured through dual-energy X ray absorptiometry
Testosterone Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Human testosterone, measured in serum via Novus Biologicals Human Testosterone ELISA Kit (Colorimetric). Measured in pg/mL.
Human Growth Hormone Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Human Growth Hormone (HGH), measured in serum via R\&D Systems™ Human Growth Hormone Quantikine ELISA Kit Measured in pg/mL
SHBG Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Sex Hormone Binding Globulin (SHBG), measured in serum via R\&D Systems™ Human SHBG Quantikine ELISA Kit; measured in pg/mL
Estradiol Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Human estradiol, measured in serum via Novus Biologicals Human Estradiol ELISA Kit (Colorimetric); measured in pg/mL
Fat Mass Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Fat mass, measured in kg and as a percentage of total body mass Measured through dual-energy X ray absorptiometry
Aromatase Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Aromatase enzyme, measured in serum via Invitrogen™ Human Aromatase ELISA Kit; measured in ng/mL
Insulin Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Insulin, measured in serum via Eagle Biosciences Inc Insulin Ultrasensitive ELISA; measured in mU/L
KISS1 Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Kisspeptin (KISS1), measured in serum via Biomatik Corporation Human Kisspeptin 1 (KISS1) ELISA Kit; measured in pg/mL
GnRH Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Gonadotropin-releasing hormone (GnRH), measured in serum via Biomatik Corporation Human Gonadotropin Releasing Hormone (GnRH) ELISA Kit; measured in pg/mL
Inflammatory Cytokine Panel Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Human High Sensitivity T-Cell 15-Plex Discovery Assay®, conducted by Eve Technologies, that includes GM-CSF, IFN-γ, IL-1β, IL-1RA, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p40, IL-12p70, IL-13, MCP-1 and TNFα; measured in pg/mL
Triglycerides Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Triglycerides, measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in mg/dL
Visceral Adipose Tissue Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Visceral Adipose Tissue (VAT), measured in g and g/cm3 via dual-energy X ray absorptiometry
Glucose Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Glucose, measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in mg/dL
HDL-C Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants High-density Lipoprotein Cholesterol (HDL-C), measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in mg/dL
- Secondary Outcome Measures
Name Time Method ALT Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Alanine Transaminase (ALT) liver enzyme, measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in U/L
Upper-body Muscle Strength Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Upper-body Muscle Strength, measured via three-repetition maximum (3RM) bench press; measured in pounds.
Blood Pressure Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Blood Pressure, both systolic and diastolic, measured with an automated blood pressure cuff; measured in mmHg.
Upper-body Muscle Power Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Upper-body Muscle Power, measured via seated medicine ball toss; measured in inches (thrown).
Lower-body Muscle Power Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Lower-body Muscle Power, measured via maximal voluntary contraction of the knee extensors with a Biodex dynamometer; measured as peak torque in Nm.
AST Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Aspartate Aminotransferase (AST), measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in U/L
Bone Mineral Density Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Whole-body Bone Mineral Density (BMD), measured via dual-energy X ray absorptiometry; measured in g/cm3
Height Baseline/enrollment Height, measured in inches via portable stadiometer
Body Mass Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Body mass, measured in kg via Seca mBCA (medical body composition analyzer) 514
Waist Circumference Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Waist Circumference, measured in inches via standard Gulick tape measure.
Free-living Dietary Intake Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Free-Living Dietary Intake, measured via 3-day food record. Participant completes the record for 3 days and returns to the researchers.
Free-living Physical Activity Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Free-living Physical Activity, assessed through accelerometry via Actigraph wGT3X-BT accelerometers. Participant wears the accelerometer for 3 days, then returns it to the researchers.
Aerobic Capacity Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Aerobic Capacity, also known as VO2peak, assessed via YMCA submaximal exercise test, completed on a cycle ergometer.
Resting Energy Expenditure Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Resting Energy Expenditure (REE), measured via indirect calorimetry. The test is conducted with a Parvo Medics True One 2400 metabolic analysis system with a canopy hood; measured as kcal/day.
Lower-body Muscle Strength Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants Lower-body Muscle Strength, measured via knee extensor test with a Biodex dynamometer and three-repetition maximum (3RM) leg press exercise; measured as peak torque in Nm and pounds, respectively.
Trial Locations
- Locations (1)
Oklahoma State University
🇺🇸Stillwater, Oklahoma, United States