Development of a Clinical Experimental Heat Stress Protocol and Exploration of the Effect of Niacinamide on Physiologic, Metabolic, and Biochemical Responses to Heat Stress
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Urinary neutrophil gelatinase-associated lipocalin
研究概览
简要总结
The goal of this clinical trial is to learn about the processes occurring in the kidneys while under heat stress in healthy volunteers. The main questions it aims to answer are:
- How do the chemicals produced by the body change under conditions of higher versus lower heat stress?
- What role does a specific area of the body's metabolism, known as NAD+ metabolism, play in the body's response to heat stress, and can this response be modified by taking vitamin B3?
详细描述
To answer these questions, researchers will compare the chemical changes in each participant under progressively higher levels of heat stress, and while taking either vitamin B3 or a placebo.
This clinical trial will occur in two stages. Participants may choose participate in stage 1 only, stage 2 only, or both parts of this clinical trial.
During stage 1, participants will exercise using a stationary rowing ergometer in a hot and humid environmental chamber for three sessions, each session separated by about a week.
- Each session, they will be asked to work out at a progressively higher intensity with climate conditions kept the same in the chamber.
- More intense exercise produces greater heat stress, resulting in lower, moderate, and higher levels of heat stress exposure across the three sessions.
- Researchers will see how chemicals in the blood and urine, along with physical measurements like heart rate and body temperature, change across these different levels of heat stress.
During stage 2, participants will exercise using the same rowing ergometer in the same environmental chamber. They will do this for two sessions, each separated by about a week.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer
- •Estimated glomerular filtration rate greater than 90 ml/min/1.73m2
- •Urine albumin/creatinine ratio less than 30mg/g
- •Nonsmoker
- •No regular dietary supplements, particularly vitamin B3
- •Physically fit, defined as having a VO2 max of between 35 and 60mL/kg/min
排除标准
- •Medical condition preventing safe participation in exercise during heat
- •Allergy to Vitamin B3
- •Severe food allergies or dietary restrictions that would preclude eating the planned study diet without major modifications
研究组 & 干预措施
Vitamin B3, then placebo
Individuals will receive 1000mg oral Vitamin B3 daily for two days leading up to their first exercise session, and oral placebo daily for two days leading up to their second exercise session.
干预措施: Vitamin B3 (Dietary Supplement)
Placebo, then vitamin B3
Individuals will receive 1000mg oral placebo daily for two days leading up to their first exercise session, and oral vitamin B3 daily for two days leading up to their second exercise session.
干预措施: Vitamin B3 (Dietary Supplement)
结局指标
主要结局
Urinary neutrophil gelatinase-associated lipocalin
时间窗: Pre- and immediately post- heat stress exposure
Marker of stress and injury in the kidney
Urinary TIMP2 (tissue inhibitor of metalloproteinase-2) and IGFBP7 (insulin-like growth factor-binding protein 7)
时间窗: Pre- and immediately post- heat stress exposure
Marker of kidney stress and injury
次要结局
- Urine Quinolinate to Tryptophan Ratio(Pre- and immediately post- heat stress exposure)
- Serum creatinine(Pre- and immediately post- heat stress exposure)
研究者
Nathan Raines
Assistant Professor of Medicine
Beth Israel Deaconess Medical Center