Assessment of BHB Concentration Agreement Among Sampling Locations and the Impact of Ketosis on Erythropoietin Levels: A Two-Part Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Venous Plasma Beta-hydroxybutyrate (BHB) From Baseline to Peak During Acute Ketosis Exposure
研究概览
简要总结
This study aims to address two key aspects. First, the suitability of selecting a specific sampling site for BHB measurement in patients and research, as well as potential differences between capillary and venous blood measurements. Additionally, the study will investigate the effects of ketosis on EPO concentrations, sex hormone levels, hemodynamic markers, and blood pressure.
This investigation will utilize blood samples collected from baseline and at Day 15, between which participants are exposed to intermittent ketosis or placebo in a randomized parallel design.
详细描述
Aim and Perspective The primary objective of this study is to ascertain The agreement between estimates of beta-hydroxybutyrate (BHB) in capillary and venous blood and whether this agreement is influenced by the level of BHB.
The agreement in BHB measurements between finger and earlobe capillary samples. The agreement in BHB measurements between venous estimates obtained through a point-of-care device (KetoSure) and full blood estimates obtained through hydrophilic interaction liquid chromatography tandem mass spectrometry (HLCMS).
A central aim of the study is also to investigate The impact of ketosis on short-term and longer-term erythropoietin (EPO) levels.
The resulting effects of EPO on erythropoiesis and iron metabolism during a two-week period of intermittent ketosis.
The effects of ketosis on sex hormones including derived factors. The effects of ketosis on hemodynamic markers and blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants are blinded to the drink (intervention) being either ketosis (obtained by ingestion of a ketone monoester drink) or placebo (a taste and volume matched drink). Drinks are provided in similar neutral unlabelled bottles
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-60 years
- •BMI 19-30 kg/m2
- •Expected ease of catheter insertion
- •Considered of sound health
- •Oral and written informed consent
排除标准
- •Inability to fully understand the consent including consent forms
- •Inability to cooperate to the study
- •electrolyte disorders
- •acute or chronic kidney disease or ompromised renal function including excess risk
- •servere hypertension
- •autoimmune disease
- •liver or bile disease
- •diabetes mellitus
- •reactive hypoglycemia or similar disorders
- •treatment with drugs, and dietary supplements with inference on key metabolic or hormonal markers, e.g. insulin, glucagon, DDP-IV inhibitors, GLP-1 RA, sulfunylurea
- •use of illegal or otherwise use of medicinal products without prescription
- •anemia or other know disease of the hematopoietic system
- •previous bariatric surgery
- •previous myocardial infarction or uncontrolled myocardial ischemia
- •recent intended/unintended weight loss
- •allergies to catheters or adhesives
研究组 & 干预措施
Ketosis
Ketosis (the condition being investigated) is obtained by ingestion of a ketone monoester
干预措施: Ketone monoester (Dietary Supplement)
Control
The control arm is a drink matched in taste, volume, appearence, and viscosity to that of the active/experimental arm
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in Venous Plasma Beta-hydroxybutyrate (BHB) From Baseline to Peak During Acute Ketosis Exposure
时间窗: Baseline (0 minutes) to peak concentration during acute ketosis exposure (0-180 minutes)
Venous plasma beta-hydroxybutyrate (BHB) concentration measured in mmol/L. The outcome represents the change from baseline (0 minutes) to the maximum observed BHB concentration during the acute ketosis exposure.
Serum Erythropoietin Concentration at Day 15
时间窗: Day 15 (end of randomized treatment)
Serum erythropoietin (EPO) concentration measured in IU/L. Values represent the mean concentration at the end of randomized treatment.
Estradiol Concentration at Day 15
时间窗: Day 15 (end of randomized treatment)
Plasma estradiol measured in pmol/L at Day 15. Values represent the mean concentration at the end of randomized treatment.
次要结局
- Serum Ferritin Concentration at Day 15(Day 15 (end of randomized treatment))
研究者
Henrik Holm Thomsen
Consultant
Central Jutland Regional Hospital