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临床试验/NCT04938726
NCT04938726已完成不适用

Ketone Monoester Supplementation in Cystic Fibrosis: A Pilot and Feasibility Study

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Pulmonary Function Testing

研究概览

简要总结

This study will examine the effects of a novel ketone monester supplement on patients with cystic fibrosis experiencing an acute pulmonary exacerbation requiring hospitalization. Patients will undergo standard testing along with blood sampling to examine concentrations of inflammatory markers. Patients will then receive the ketone supplement for 5 days followed by post-testing to examine changes in pulmonary function and inflammatory markers

详细描述

Up to 25 hospitalized patients with cystic fibrosis will take part in this study at UAB. Patients will be randomly assigned to receive either an exogenous ketone or placebo supplement. Participants will take the ketone or placebo for 5 days during hospitalization. Participants will drink one 60 mL bottle twice daily of either the ketone or placebo. On day 1 and day 5, before the patient drinks the ketone (or placebo) the patient will be asked to fast overnight for 8 hours. Following administration of the first morning dose of ketones (or placebo) blood samples will be obtained from a finger stick before (time 0 min) and following (15, 30, 60, 90, and 120 min) after they drink the supplement. A commercially available ketone meter (Keto-Mojo, Napa, CA) that provides instant assessment of circulating ketone concentrations will be used to measure ketone concentrations in the blood. Medical history history will be obtained at hospitalization. The study team will also examine the body for any abnormal signs and symptoms. Sputum and blood will be collected prior to and following the ketone supplement or placebo. The hypothesis is that ketone supplementation will reduce inflammation via a well known inflammatory pathway to improve outcomes in patients with cystic fibrosis experiencing an acute pulmonary exacerbation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

All involved with blinded, except for the study pharmacist

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of CF
  • Colonization with P. Aeruginosa
  • Acute pulmonary exacerbation requiring inpatient care

排除标准

  • Concurrent or recent (within 28 d of enrollment) use of corticosteroids
  • Inability to produce sputum
  • Acute respiratory failure
  • Chronic liver or renal disease
  • Pregnancy

结局指标

主要结局

Pulmonary Function Testing

时间窗: 5 days

FEV1.0 (L/sec)

Inflammatory Markers

时间窗: 5 days

Interleukin 1Beta (pg/mL)

次要结局

  • Subjective Respiratory Quality of Life(5-7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric P. Plaisance

Associate Professor and Chair

University of Alabama at Birmingham

研究点 (2)

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