Safety of Graded-Dose of Histidine as Determined by Circulating Analytes, Sleep Records, Physical Activity, Anthropometric Measurements, and Mood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- HgbA1c in %
研究概览
简要总结
Histidine is an essential amino acid with health benefits that include anti-inflammatory, anti-oxidant, glucoregulatory, and weight management. The current expert opinion for histidine intake is 8 and 12 mg/(kg body weight per day), an estimate that was extrapolated from the infant requirement for histidine. Further, the clinical safety of histidine supplementation above the average dietary intake has not been determined.The overarching objectives are to 1) measure the safety of histidine supplementation and 2) measure the potential benefits of histidine at doses above the average intake and current recommendation in a healthy adult population.
详细描述
Histidine is an essential amino acid with health benefits that include anti-inflammatory, anti-oxidant, glucoregulatory, and weight management. Because of the extended period of time (>35 days) that is required to deplete body histidine pools in adults, it has not been possible to fully determine histidine requirements. The current expert opinion for histidine intake is 8 and 12 mg/(kg body weight per day), an estimate that was extrapolated from the infant requirement for histidine. The average intake of histidine from a normal adult diet in the U.S., Europe, and Japan was reported between 2.12 and 2.40 g/day with the 99th percentile intake in men at 50-70 years of age consuming 5.20 g/day. The clinical safety of histidine supplementation above the average dietary intake has not been determined. Therefore, this study will utilize graded doses of histidine that are at are moderately above the average intake to identify safety and benefits of histidine in a healthy human population. Further, the clinical safety of histidine supplementation above the average dietary intake has not been determined.The overarching objectives are to 1) measure the safety of histidine supplementation and 2) measure the potential benefits of histidine at doses above the average intake and current recommendation in a healthy adult population. Following the completion and review of a health history questionnaire, vitals, and a biochemical panel, participants will be deemed healthy by a nurse practitioner and able to participate. After baseline measures are obtained, supplements (encapsulated histidine) will be provided at three graded doses (4 g/day, 8 g/day and 12 g/day) a forth dose (16 g/day) will be consumed if no adverse effects are observed at the three graded doses. Each dose will be for 28 days followed by a three week recovery period. At baseline, weeks 2 and 4 of supplement, and recovery a basic biochemical panel, anthropometric, urinary and serum zinc, will be conducted. Additionally, body composition will be conducted at baseline and week 4 of each dose. Changes in dietary intake and physical activity will be measured with 4-day food records and Actigraph activity monitors, respectively. Changes in sleep patterns will be measured with the Pittsburgh sleep questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy young males and females aged 21-50 y.
排除标准
- •A body-mass index (BMI) <19.9 kg/m2 or > 29.9 kg/m2
- •taking/on immunosuppressive medications or prescription anti-coagulation therapy
- •pregnancy
- •breastfeeding
- •musculoskeletal disorder
- •alcoholism (>11 drinks per week for women, >14 drinks per week for men) or other drug addiction
- •acute illness
- •inability to travel to Cornell University campus
- •A blood pressure at or above 140/90
- •For individuals desiring to participate in the optional biopsy, a history of a negative or allergic reaction to local anesthetic is an exclusion criteria
结局指标
主要结局
HgbA1c in %
时间窗: at week 4 of each dose
The safety of histidine supplementation at each dose is monitored through circulating HgbA1c
Change in heart rate in beats per minute
时间窗: weeks 0 (baseline and washout), 1, 2, 3, and 4 of each dose
The safety of histidine supplementation at each dose is monitored through heart rate
Change in concentration of zinc in mg/ml
时间窗: at week 0 and 4 of each dose
The safety of histidine supplementation at each dose is monitored through blood markers of zinc
Change in concentration of C-reactive protein mg/L
时间窗: at weeks 0 (washout), 2 and 4 of each dose
The safety of histidine supplementation at each dose is monitored through circulating CRP
Change in concentration of liver enzymes (ALT, ALP, and AST) in Units per Liter
时间窗: at weeks 0 (washout), 2 and 4 of each dose
The safety of histidine supplementation at each dose is monitored through circulating liver enzymes
Change in concentration of total protein and albumin in g/dl
时间窗: at weeks 2 and 4 of each dose
The safety of histidine supplementation at each dose is monitored through circulating total protein and albumin
Change in body weight in kilograms
时间窗: at weeks 0 (washout), 2 and 4 of each dose
The safety of histidine supplementation at each dose is monitored through changes in weight
Change in concentration of blood urea nitrogen, Creatinine, bilirubin and glucose each in mg/gL
时间窗: at weeks 0 (washout), 2 and 4 of each dose
The safety of histidine supplementation at each dose is monitored through circulating blood urea nitrogen, Creatinine, bilirubin and glucose
Change in systolic and diastolic blood pressures in mmHG
时间窗: weeks 0 (baseline and washout), 1, 2, 3, and 4 of each dose
The safety of histidine supplementation at each dose is monitored through blood pressure
次要结局
- Change in dietary intake of energy, macronutrients, and amino acids measured in kcals and g/day with 4 day food record(week 0 to 4 of each dose)
- Change in subjective mood measured in arbitrary units(week 0 to 4 of each dose)
- Change in subjective desire to eat measured in arbitrary units(week 0 to 4 of each dose)
- Change in hours of sleep(week 0 to 4 of each dose)
- Change in physical activity measured in steps per day(week 0 to 4 of each dose)