Breath Ammonia as a Malnutrition Screening Tool
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Breath Ammonia
研究概览
简要总结
The purpose of this research study is to understand how breath is related to nutritional status. The procedures involved in this study include blood and breath sampling, questionnaires about health history, medications, nutritional status and diet, and a physical examination. Breath markers will be compared between individuals with and without malnutrition and be compared to indicators of malnutrition. Some individuals will undergo an interventional study involving 2 days of consuming study beverages and fasting along with providing additional breath samples to see if the breath changes in response to short-term changes in nutritional status.
详细描述
Research Summary: This research involves a cross-sectional study investigating whether breath molecules (in particular ammonia and nitric oxide) are related to the presence and magnitude of malnutrition as measured by the gold-standard nutrition focused physical examination (NFPE). It also involves an interventional study in a subset of cross-sectional participants looking at whether acute changes in nutritional status through anabolic feeding protocols or fasting protocols is related to short term changes in breath molecules.
Purpose of the Research: The purpose is to identify early evidence of breath biomarkers of malnutrition. It uses a combination of breath analysis and current malnutrition screening tools (questionnaires).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The randomization scheme will be blinded to the PI and biostatistician. Due to the intervention (feeding vs fasting), the participant and other study staff cannot be blinded.
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-95 years
- •Malnutrition group (Cross-sectional study only); not involved in intervention: Diagnosed with malnutrition (verified in medical history)
排除标准
- •Chronic kidney, liver or pulmonary disease
- •Anabolic steroid use other than testosterone (e.g., oxandrolone)
- •Patients judged unsuitable for enrollment by the study medical investigator
- •Pregnant women or women who are nursing
- •Unable or unwilling to consume study beverages or fast for 24 hours each arm
结局指标
主要结局
Breath Ammonia
时间窗: Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms
Breath ammonia (ppm)
次要结局
- Breath volatile organic compounds(Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms)
- Fractional Exhaled Nitric Oxide(Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms)
研究者
Jacob T. Mey, PhD RD
Assistant Professor - Research
Pennington Biomedical Research Center