NCT05472168招募中不适用
SNEEX - Impact of Olfactory Odour StimulatioN on Energy EXpenditure
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年1月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in Energy Expenditure
研究概览
简要总结
In this preliminary short-term study it is investigated, whether a short olfactory stimulation with distinct odours impacts energy expenditure in patients with obesity and lean patients.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Age 18-55 years
- •Obesity (BMI ≥30 kg/m2) and Lean (BMI 18-25 kg/m2)
- •Written informed consent
- •Normosmia (defined by sniffing Sticks test)
排除标准
- •• Chronic or acute sinusitis
- •Surgical intervention of the nasal cavity or the paranasal sinus
- •Known allergy to odors used in the study
- •Current illicit drug abuse including daily marijuana and cannabidiol (CBD) consumption (alcohol ≤2 drinks per day allowed)
- •Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease)
- •Diabetes mellitus
- •Treatment with insulin sensitizing drugs including Glucagon-like Peptide (GLP)-1 analogues within the last 3 months
- •History of neurodegenerative diseases, severe head trauma
- •Severe renal impairment (e.g. estimated glomerular filtration rate <30 ml/min/m2)
- •Known liver cirrhosis or other severe liver impairment
- •Use of any kind of decongestant more than twice a week
- •Use of cortisone-containing nasal spray within the last 3 months
- •Acute upper respiratory tract infection
- •Uncontrolled dysthyroidism
- •Uncontrolled hypertension
- •Regular use of psychopharmaceutic drugs
- •Study participants aims to start a new diet or exercise program during the study
- •Bariatric surgery
- •Pregnancy/Lactation
- •Onset of climacteric symptoms within one year (e.g. hot flashes and/or diaphoresis) OR initiation of hormonal replacement therapy in the last three months
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- •Participation in an interventional study within the last 3 months
结局指标
主要结局
Change in Energy Expenditure
时间窗: 6 hours
change in energy expenditure as assessed via calorimetry after olfactory stimulation with different odours.
次要结局
- Energy Expenditure, Additional Odours(6 hours)
- Metabolic Parameters(6 hours)
- Glucose Levels(6 hours)
- Heart Rate(6 hours)
- Blood Pressure(6 hours)
研究者
Katharina Timper
Principal Investigator, Prof. Dr. med.
University Hospital, Basel, Switzerland
研究点 (1)
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