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临床试验/NCT06432504
NCT06432504招募中不适用

Variation in the Impact of Coffee on the Metabolic Rate

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Expired gases

研究概览

简要总结

The purpose of this study is to explore variation in the impact of coffee on metabolic rate. The investigators plan to recruit healthy participants, half male and half female.

详细描述

The investigators will study the variation in the impact of coffee on metabolic rate and investigate the impacts of age, sex, body composition and regularity of habitual coffee consumption on this effect. The investigators will recruit healthy participants, half male and half female. Participants will be required to perform no strenuous exercise for 14 hours and no moderate of vigorous exercise for 2 hours before the measurements. When the participants arrive at the lab on the day of the experiment, they will sign an informed consent form, a health history questionnaire and a daily coffee consumption questionnaire. Participants will be randomly allocated into 3 groups and given 180mls of coffee to consume containing 100, 200 or 300 mg of caffeine. A fourth group will be dosed with 100 mg of caffeine containing 13C uniform labelled caffeine to trace the pattern of caffeine degradation via the appearance of 13CO2 in the breath and labelled compounds in the urine. The primary outcome is the change in resting metabolic rate from before and after coffee drinking. Secondary outcome measures are heart rate, electrocardiogram, blood pressure, body temperature which will be measured before and after the coffee consumption. Professional nurses will take 8ml of venous blood from all participants as genotyping blood samples. Genomic DNA will be extracted from whole blood samples and analysed for single nucleotide polymorphisms (SNPS).

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 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adults 18-40 years old

排除标准

  • Those who have undergone surgery in the past 6 months. People are requiring long-term medication. People have metabolic diseases, like diabetes, hypoglycemia, gout, osteoporosis, etc.
  • People have digestive diseases, like gastric ulcer, pancreatitis, intestinal obstruction, etc.
  • Those who have recently lost weight for various medical reasons ( like cancer, etc.).
  • People are suffering from infectious diseases ( like HIV, etc.). People have blood phobia, pathological hypo or hyper tension. People with impaired glucose tolerance. Those who are afflicted with claustrophobia.

结局指标

主要结局

Expired gases

时间窗: On the first moring of experiment, it lasts 0.5 hours and 3 hours.

Gases will be collected before and after coffee consumption, Gases will be measured by CO2 isotope analyzer (CCIA2-912) to observe the change of labelled CO2.

Resting energy expenditure

时间窗: On the first moring of experiment, it lasts 0.5 hours and 3 hours.

Resting energy expenditure will be measured using indirect calorimetry via a respiratory hood system (COSMED). The subject attends in the lab after an overnight fast. The person lies down on a flat bed and the hood is placed over their head. Resting energy expenditure will be measured before and after coffee consumption. The extra energy expenditure is equal to the resting energy expenditure after drinking coffee minus the resting energy expenditure before drinking coffee.

Urine metabolites

时间窗: On the first moring of experiment, it lasts 0.5 hours and 3 hours.

The contents of metabolites will be measured by gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS ).

次要结局

  • Body temperature(On the first moring of experiment, it lasts 0.5 hours and 3 hours.)
  • Body weight(On the first moring of experiment, it lasts 5 minutes.)
  • Blood pressure(On the first moring of experiment, it lasts 0.5 hours and 3 hours.)
  • Electrocardiogram (ECG)(On the first moring of experiment, it lasts 0.5 hours and 3 hours.)
  • Fat free mass(On the first moring of experiment, it lasts 5 minutes.)
  • Height(On the first moring of experiment, it lasts 5 minutes.)
  • Body water, extracellular fluid and intracelluar fluid(On the first moring of experiment, it lasts 0.5 hours and 3 hours.)
  • Blood samples(Baseline : empty stomach On the first moring of experiment.)
  • Fat mass(On the second moring of experiment, it lasts 10 minutes.)
  • Bone mass(On the first moring of experiment, it lasts 10 minutes.)
  • Heart rate(On the first moring of experiment, it lasts 0.5 hours and 3 hours.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John R. Speakman

Professor

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

研究点 (1)

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