NCT04223284已完成不适用
Olfactory Odour Stimulation for Metabolism Control - the "OLFAMET-Study"
University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2019年12月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change of area under blood glucose curve (AUBGC)
研究概览
简要总结
In this preliminary short-term study it is investigated, whether a short olfactory stimulation with D-Limonene leads to an acute improvement of glucose metabolism in patients with obesity.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Obesity (BMI ≥35 kg/m2)
- •Written informed consent
- •Normosmia (defined by sniffin Sticks test)
排除标准
- •Known allergy to D-Limonene, citrus fruits, citrus flavours, SLVO
- •Regular smoking
- •Current illicit drug abuse including daily marijuana and cannabidiol (CBD) consumption (alcohol ≤2 drinks per day allowed)
- •Diabetes mellitus
- •Pre-Treatment with insulin sensitizing drugs including GLP-1 analogues
- •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
- •Acute upper respiratory tract infection
- •Uncontrolled dysthyroidism
- •Uncontrolled hypertension
- •Regular use of psychopharmaceutic drugs
- •Patient aims to start a new diet or exercise program during the study
- •Bariatric surgery
- •Pregnancy/Lactation
- •Symptoms of menopause
- •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 of area under blood glucose curve (AUBGC)
时间窗: Time Frame: baseline blood exam (timepoint 0) and further blood collections: 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution
area under the blood glucose curve (AUBGC) during a mixed-meal test after stimulation with D-Limonene compared to baseline
次要结局
- Change in plasma levels of glucagon-like peptide 1 (GLP-1)(Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
- Change in plasma levels of Leptin(Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
- Change in plasma Levels of Interleukin-6(Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
- Change in plasma peak glucose levels(Time Frame: baseline blood exam (timepoint 0) and further blood collections: 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
- Change in plasma levels of lipids like LDL-cholesterine, total cholesterine, triglycerides(Time Frame: baseline blood exam (timepoint 0) and further blood collections: 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
- Visual Analogue Scale (VAS score)(Time Frame: baseline VAS score (timepoint 0) and VAS scores will be evaluated after 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
- Change in plasma insulin levels(Time Frame: baseline blood exam (timepoint 0) and further blood collections: 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
- Change in heart rate(Blood pressure and heart rate will be measured at the following times: baseline (timepoint 0) and 30, 60, 120 minutes drinking a standardized mixed-meal solution)
- Change in blood pressure(Blood pressure and heart rate will be measured at the following times: baseline (timepoint 0) and 30, 60, 120 minutes drinking a standardized mixed-meal solution)
- Change in plasma levels of gastric inhibitory polypeptide (GIP)(Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
- Change in plasma levels of Peptide YY (PYY)(Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
- Change in plasma Levels of C-reactive protein(Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
- AUBGC(Time Frame: baseline blood exam (timepoint 0) and further blood collections: 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
- Change in plasma levels of Ghrelin(Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
- Change in plasma levels of Glucagon(Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
研究者
研究点 (2)
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