Abundance of a Natural Odour in Human Cerebrospinal Fluid After Olfactory Exposure - the OLFO-Brain Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Detection of a natural odour in human CSF
研究概览
简要总结
The goal of this clinical trial is to investigate the abundance of a natural odour in human cerebrospinal fluid in obese and lean participants after inhalation thereof. Participants will undergo blood sample collection and inhalation of either a natural odour or placebo through an inhaler in addition to a liquor puncture prescribed in standard of care context.
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
- Single (Participant)
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
- •Obese Participants:
- •Age 18-60 years
- •Written informed consent
- •Scheduled for routine liquor puncture
- •BMI ≥ 30 kg/m2
- •No proven diagnose of diabetes
- •Inclusion Criteria Lean Participants:
- •Age 18-60 years
- •Written informed consent
- •Scheduled for routine liquor puncture
- •BMI 18-25 kg/m2
排除标准
- •Known allergy to the natural odour
- •Acute upper respiratory tract infection, acute or chronic sinusitis
- •Present or past surgical intervention of the nasal cavity, the paranasal sinus, the pituitary or the frontal brain
- •Pregnancy/lactation
- •Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease, severe renal impairment with an estimated glomerular filtration rate <30 ml/min/m2)
- •Inability to understand the study procedure and to sign the study consent
研究组 & 干预措施
Verum (natural odour)
Participants will inhale 50 uL of a natural odour contained in mini-inhaler over a period of 15 min.
干预措施: Inhalation - Natural Odour (Combination Product)
Placebo Inhalation
Participants will inhale 50 uL of placebo (propylene glycol) contained in mini-inhaler over a period of 15 min.
干预措施: Inhalation - Placebo (Combination Product)
结局指标
主要结局
Detection of a natural odour in human CSF
时间窗: 1 time assessment at baseline
Detection of a natural odour in human CSF within 30 min following end of an 15 min olfactory stimulation thereof compared to placebo. The presence of the Verum (natural odour) will be assessed via Gas Chromatography-Mass Spectrometry. This will be analyzed using a binary logistic regression model to determine the odds ratio of detecting a natural odour in the CSF post-stimulation. The model will account for variables such as age, sex, and BMI category (obese vs. lean). The significance level will be set at p \< 0.05.
次要结局
- Change in abundance of a natural odour in blood before and after olfactory stimulation in relation to abundance in human CSF.(2 times assessment at baseline (immediately before olfactory stimulation and within 30 min following end of olfactory stimulation))
- Abundance of a natural odour in human CSF of obese versus lean participants(1 time assessment at baseline)
- Change in abundance of a natural odour in blood before and after olfactory stimulation in obese as compared to lean participants.(2 times assessment at baseline (immediately before olfactory stimulation and within 30 min following end of olfactory stimulation))