The Interaction of Body Composition, Sex Hormones and Exercise in Men

Обзор

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.

Вмешательства

• Поведенческое Resistance Exercise Training
  12-week progressive and individualized resistance exercise training program
• Поведенческое Aerobic Exercise Training
  12-week progressive and individualized aerobic exercise training program

Первичные конечные точки

• Fat Mass [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
• Lean mass [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
• Testosterone [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
• Human Growth Hormone [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
• Estradiol [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
• SHBG [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
• Luteinizing Hormone [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
• FSH [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
• Adiponectin [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
• Leptin [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]

Вторичные конечные точки (12)

• ALT [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
• AST [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
• Bone Mineral Density [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
• Height [Срок оценки: Baseline/enrollment]
• Body Mass [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
• Waist Circumference [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
• Aerobic Capacity [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
• Resting Energy Expenditure [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Oklahoma State University — Stillwater

Идентификаторы

NCT: NCT06970457 · IRB-24-542

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗