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临床试验/NCT04910724
NCT04910724已完成不适用

Effects of Varying Energy Deficits on Protein Turnover At Rest and Carbohydrate Oxidation During Steady-state Exercise

United States Army Research Institute of Environmental Medicine2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Whole-body protein balance

研究概览

简要总结

This randomized, parallel study will examine the effects of energy balance and varying magnitudes of energy deficit on 1) the protein kinetic responses to consuming high quality protein and 2) carbohydrate oxidation during steady-state exercise. Healthy adults, representative of active duty military personnel, will complete a 2 d energy balance phase followed by a randomly assigned, 5 d energy deficit phase (n=15 per group; 20%, 40% and 60% energy deficit). At the end of each energy phase the effects of energy balance and energy deficit severity on resting postabsorptive (fasting) and postprandial (after consuming ~34 g protein) muscle protein synthesis (MPS) and whole-body protein synthesis, breakdown, and balance (synthesis - breakdown) will be determined. On the next day, the effects energy balance and energy deficit severity on carbohydrate oxidation during steady-state exercise will be determined. Primary study procedures include anthropometric and body composition measures, resting metabolic rate measures, aerobic exercise, tightly controlled diet and exercise interventions, repeated blood sampling, stable isotope infusion, stable isotope ingestion, and percutaneous muscle biopsies. The following hypotheses will be tested: 1) Δ (postprandial - postabsorptive) MPS and Δ whole-body protein balance at rest will progressively decrease as magnitude of energy deficit increases and 2) exogenous carbohydrate oxidation will be higher and endogenous carbohydrate oxidation will be lower during steady-state exercise as magnitude of energy deficit increases.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged 18 - 35 years
  • Body mass index < 30.0 kg/m2
  • Weight stable for the past 2 months (± ~2.27 kg)
  • Healthy without evidence of chronic illness or musculoskeletal injury as determined by the US Army Research Institute of Environmental Medicine Office of Medical Support and Oversight (OMSO) or home duty station medical support
  • Routinely participate in aerobic and/or resistance exercise at least 2 days per week defined by self-report for previous 6 months
  • Willing to refrain from taking any nonsteroidal anti-inflammatory drugs (e.g., aspirin, Advil®, Aleve®, Naprosyn®), or any other aspirin-containing product for 10 days before the first muscle biopsy and at least 5 days after completing the last muscle biopsy
  • Willing to refrain from alcohol, smoking/using any nicotine product (includes e-cigarettes, vaping, chewing tobacco), caffeine, and dietary supplements during the intervention periods of the study
  • Supervisor approval for federal civilian employees and non-Natick Soldier Systems Center Human Research Volunteer (HRV) active duty military personnel
  • Females must have normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or able to provide documentation of oral/hormonal contraceptive use which contains low-dose estrogen/progesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos)

排除标准

  • Metabolic or cardiovascular abnormalities, gastrointestinal disorders (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
  • Significantly abnormal blood clotting as determined by OMSO or home duty station medical support
  • History of complications with lidocaine
  • Present condition of alcoholism, anabolic steroid use, or other substance abuse issues as determined by OMSO or home duty station medical support
  • Blood donation within 8-wk of beginning the study
  • Pregnant, trying to become pregnant, and/or breastfeeding (results of urine pregnancy test and self-report for breastfeeding will be obtained before body composition testing)
  • Unwilling or unable to consume study diets or foods provided due to personal preference, dietary restrictions, and/or food allergies
  • Unwilling or unable to adhere to study physical restrictions

结局指标

主要结局

Whole-body protein balance

时间窗: 2 days

Determined using L-\[1-13C\]-leucine stable isotope.

Muscle Protein Synthesis

时间窗: 2 days

Determined using L-\[ring-2H5\]-phenylalanine stable isotope.

Carbohydrate Oxidation during Steady-state Exercise

时间窗: 2 days

Determined using U-13C-glucose stable isotope.

次要结局

未报告次要终点

研究者

发起方
United States Army Research Institute of Environmental Medicine
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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