NCT06743009招募中不适用
The Metabolic Effects of the Exercise-metabolite N-lactoyl-phenylalanine (Lac-Phe)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- ad libitum meal test
研究概览
简要总结
The goal of this double-blinded, randomized cross-over clinical trial is to assess the isolated (i.e. outside the context of exercise) effects of Lac-Phe on appetite and glucose concentrations in healthy volunteers with obesity (BMI 28-35).
The main questions it aims to answer are:
- Does Lac-Phe reduce appetite in humans?
- Does Lac-Phe have glucose-lowering properties in humans?
During the study, participants will:
- receive an intravenous infusion of Lac-Phe on one study day and a NaCl infusion on another study day.
- drink a standard mixed meal
- eat an ad libitum meal test
- answer appetite questionnaires
- indirect calorimetry
- blood samples for hormone and substate analyses
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A body mass index (BMI) between 28-35 kg/m2
- •Older than 18 years of age
- •Hgb within a normal range (females: 7.3-9.5 mmol/L, males: 8.3-10.5 mmol/L)
- •Females can be included if they are either postmenopausal or actively use hormonal contraception (e.g., oral contraceptive pill or hormone-releasing intrauterine device).
排除标准
- •Medications affecting glucose metabolism (e.g., Saxenda).
- •Ongoing cancer or other acute/chronic serious diseases (PI will determine)
- •Inability to understand Danish or English
- •Deemed unsuitable to participate by the PI and co-investigators.
结局指标
主要结局
ad libitum meal test
时间窗: On the study day, from times 240 minutes and until meal completion as assessed by study participant
Meal intake (kcal) during the ad libitum meal test
次要结局
- Lac-phe(During the study day, time 0-240 minutes)
- glucose(During the study day, time 0-240 minutes)
- lactate(During the study day, time 0-240 minutes)
- c-peptide(During the study day, time 0-240 minutes)
- triglycerider(During the study day, time 0-240 minutes)
- GLP-1(During the study day, time 0-240 minutes)
- GIP(During the study day, time 0-240 minutes)
- Ghrelin(During the study day, time 0-240 minutes)
- insulin(During the study day, time 0-240 minutes)
- free fatty acids(During the study day, time 0-240 minutes)
- LEAP2(From baseline to end of study day (time 0-240 minutes))
- Glucagon(From baseline to end of study day (time 0-240 minutes))
- Gastric emptying assessed by acetaminophen(From baseline to end of study day (time 0-240 minutes))
- Subjective appetite - appetite questionaire(Hourly thoughout the study - times 0, 60, 120, 180 and 240 minutes)
- Energy expenditure(After 60 and approx 180 minutes)
研究者
研究点 (2)
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