DRKS00024755已完成未知
Metabolic Responses to Glucose and Fructose supplementation in healthy individuals: a double-blind randomized crossover-controlled trial (MERGE1) - MERGE1
niversität Bayreuth Institut für Sportwissenschaften Division of Exercise Physiology and Metabolism0 个研究点目标入组 15 人开始时间: 2021年6月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Informed consent obtained
- •- Body mass index 18.0–29.9 kg/m2 (both inclusive)
- •- Normal glucose tolerance (measured via overnight fasting blood glucose levels)
排除标准
- •- Enrolment in other study
- •- Known or suspected hypersensitivity to trial product(s) or related products
- •Receipt of any investigational medicinal product within 1 week prior to screening in this trial
- •-Suffer from or history of a life-threatening disease (i.e. cancer judged not to be in full remission except basal cell skin cancer or squamous cell skin cancer)
- •- Suffer from or history of a clinically severe diseases that directly influence the study results, as judged by the Investigator. This does not prohibit the participation of patients taking medications that influences the metabolism (e.g. statin) or cardio-respiratory system (e.g. asthma spray) as long as the therapy is stable and is not adapted throughout the run of the trial. Furthermore, it does not excluded patients how have celiac disease (or similar diseases or allergies), as long as the disease is stable, and patients are able to stay on their specific (e.g.) gluten-free diet.
- •- Suffer from any chronic (metabolic) disorder or severe disease which, in the opinion of the Investigator might jeopardise participant’s safety or compliance with the protocol
- •-heart rate <35 beats per minute (bpm) at screening (after resting for 5 min in supine position)
- •- Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-150 mmHg for systolic or 50-95 mmHg for diastolic (excluding white-coat hypertension).
- •- Significant abnormal ECG at screening, as judged by the Investigator
- •- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
- •- mental incapacity or language barriers precluding adequate understanding or cooperation
- •- people who, in the opinion of their general practitioner or the Investigator, should not participate
- •- Any condition that would interfere with trial participation or evaluation of results, as judged by the Investigator
- •- Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (including sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner)
研究者
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