Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Hypercapnic Ventilatory Response (HCVR)
研究概览
简要总结
Exogenous ketones (EK) are compounds that can increase the level of ketones in the body without needing to change what an individual eats.
Although EK have been researched mainly in relation to energy and exercise, there haven't been many studies focusing specifically on how EKs affect breathing using well-established scientific methods. The investigators believe that EK may help improve breathing, which could be beneficial for situations like high altitudes, sleep apnea, and exercise.
To explore how EK might influence breathing, the investigators are conducting a randomized, placebo-controlled crossover study with healthy volunteers.
详细描述
Healthy volunteers will undergo daytime hypercapnic ventilatory response (HCVR) testing before and after ingesting 40g of exogenous ketones or placebo. Circulating ketone levels (beta-hydroxybutyrate) will be measured at baseline, 1 hour, and 2.5 hours after ingestion (immediately before HCVR testing). Studies will require two visits with a minimum of 48 hr. (and up to a max of 14 days) of washout.
The specific ketone product to be tested is 1,3 butanediol (1,3BD) in a commercially available formulation called "Ketone IQ". A taste-matched placebo will also be supplied by the sponsor. 1,3BD is converted by liver metabolism into the ketone body beta-hydroxybutyrate (BHB) and has been utilized in multiple studies.
PROCEDURES:
This is a randomized, single-blind, crossover study. Each participant will complete two testing sessions with a minimum of 48-hour washout period between visits. The single-blind design enables research staff to measure BHB levels and assess pharmacokinetic timing for potential adjustments to procedure timing, while keeping participants blinded to the intervention.
Baseline visit: A medical history and physical examination will be performed. A urine pregnancy screening test will be conducted for women under 60 years of age. A "run-in" procedure will be performed to confirm that participants can tolerate the taste of the ketone supplement. Participants will then be randomized to one of two arms:
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI of 18 - 30 kg/m2
排除标准
- •No concomitant sleep disorder (e.g. sleep apnea, insomnia, restless leg syndrome, narcolepsy, idiopathic hypersomnia). If there is no known diagnosis of sleep apnea, a STOP-BANG score of 5 or higher is an exclusion.
- •No current daytime respiratory impairment such as uncontrolled asthma, or uncontrolled Chronic Obstructive Pulmonary Disease (COPD), pneumonia, interstitial lung disease.
- •No known history of chronic renal disease or diabetes (type 1 or type 2).
- •No use of supplemental oxygen.
- •Cannot be on a low carbohydrate (<130 g carbohydrate/day) or ketogenic diet, intermittent fasting, or consuming exogenous ketones
- •Cannot be pregnancy or breastfeeding
- •Cannot be on medications: acetazolamide or Sodium-glucose cotransporter-2 (SGLT2) inhibitor, daily opioid use.
- •No history of claustrophobia or panic disorder
- •No frequent alcohol intake (more than 1 drink per day on average, or > 10 drinks per week).
结局指标
主要结局
Hypercapnic Ventilatory Response (HCVR)
时间窗: During each visit, one measurement at baseline, repeated again 2.5 hours after ingesting Ketone-IQ or Placebo
Minute ventilation (L/min) while breathing 7% Carbon Dioxide (CO2). Measured once during each visit.
次要结局
- Ketone Level(During each visit measured 4 times (baseline, 1 hour, 2.5 hours post-ingestion))