The Interaction of Body Composition, Sex Hormones and Exercise in Men
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Lean mass
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Resistance Exercise Training
12-weeks of progressive and individualized resistance exercise training
干预措施: Resistance Exercise Training (Behavioral)
Resistance Exercise Training
12-weeks of progressive and individualized resistance exercise training
干预措施: Aerobic Exercise Training (Behavioral)
Aerobic Exercise Training
12-weeks of progressive and individualized aerobic exercise training
干预措施: Resistance Exercise Training (Behavioral)
Aerobic Exercise Training
12-weeks of progressive and individualized aerobic exercise training
干预措施: Aerobic Exercise Training (Behavioral)
结局指标
主要结局
Lean mass
时间窗: 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
KISS1
时间窗: 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
Fat Mass
时间窗: 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
Testosterone
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
Luteinizing Hormone
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
Aromatase
时间窗: 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
时间窗: 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
GnRH
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
Total Cholesterol
时间窗: 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
次要结局
- Body Mass(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(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(Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants)
- Blood Pressure(Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants)
- ALT(Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants)
- AST(Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants)
- Bone Mineral Density(Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants)
- Height(Baseline/enrollment)
- Waist Circumference(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(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(Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants)
- Aerobic Capacity(Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants)
- Resting Energy Expenditure(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(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(Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants)