Supplementation Trial on Arginine With Metabolic Profiling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Growth Hormone
研究概览
简要总结
This study will assess effects of an acute dose of the amino acid arginine on metabolism in healthy young men.
详细描述
A double - blind randomized, crossover design trial examining arginine vs. placebo beverage treatments will be performed. The primary objective is to determine the effects of arginine assessed by standard laboratory assays and metabolomics. To accomplish the objective standardized meals will be provided for 2 days preceding treatment for dietary consistency. Participants will arrive at the center following a 10-12 hr fast. Blood samples will be collected at baseline (fasting), 1.5 hrs, 3.0 hrs, 6.0 hrs, and 24 hrs post treatment. Plasma prolactin, growth hormone, amino acids, glucose, insulin, triacylglycerols, thyroid hormones (TSH, T3, and T4), sex hormone binding globulin (SHBH), testosterone, cortisol, DHEA, and citrulline will be measured. Metabolomics will be measured at 3 time points for each treatment. Peripheral arterial tonometry (PAT) will also be performed at ~2 hrs following treatment to examine endothelial function in response to nitrous oxide release. In addition, psychological status including fatigue will be assessed using a standardized mood questionnaire (POMS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI 18.5 - 25 kg/m
- •Must be physically active (exercise at least 2 days/week).
- •Willing to refrain from alcohol and supplements for the duration of the study.
- •Willing to refrain from supplement ingestion, nuts, watermelon, and cracklins (fatback) for the 2 weeks prior to the initial treatment diet through the duration of the study.
排除标准
- •HIV or AIDS
- •Uncontrolled CVD/arrhythmia
- •Type I or type II diabetes
- •Pregnancy (or breastfeeding)
- •Diagnosed eating disorder
- •Non-normal sleeping patterns
- •Chronic neurological condition
- •Altered metabolism including growth hormone disorders
- •Use of nicotine or tobacco products
- •Heavy caffeine use (≥ 350 mg caffeine/d)
- •Whole blood donation within previous eight weeks
- •Protein supplementation
- •Protein wasting disease.
- •Exclusionary medications include diuretics, beta-blockers, weight loss medications or diet pills, anti-inflammatory drugs (corticosteroid/ anabolic steroid/NSAID), antipsychotic medication or other medication that may affect fluid balance, metabolism, or body weight.
- •Prisoners and adults who are unable to consent will be excluded from the study.
- •Lastly any other medical, psychiatric, or behavioral factors in the judgement of the Principle Investigator that may interfere with study participation or the ability to follow the protocol.
结局指标
主要结局
Growth Hormone
时间窗: baseline (fasting), 1.5, 3.0, 6.0, and 24.0 hrs
Change in GH
次要结局
未报告次要终点
研究者
John Apolzan
Asst Professor
Pennington Biomedical Research Center