Clinical trial NCT06432504: Variation in the Impact of Coffee on the Metabolic Rate
Official title: Variation in the Impact of Coffee on the Metabolic Rate
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Coffee
Caffeine
Metabolic rate
Caffeine clearance
Lead sponsor: Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

Healthy adults 18-40 years old

Exclusion Criteria:

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.

Primary outcomes:
measure: Resting energy expenditure
timeFrame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
measure: Urine metabolites
timeFrame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
measure: Expired gases
timeFrame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Secondary outcomes:
measure: Body temperature
timeFrame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
measure: Electrocardiogram (ECG)
timeFrame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
measure: Blood samples
timeFrame: Baseline : empty stomach On the first moring of experiment.
measure: Blood pressure
timeFrame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
measure: Height
timeFrame: On the first moring of experiment, it lasts 5 minutes.
measure: Body weight
timeFrame: On the first moring of experiment, it lasts 5 minutes.
measure: Fat mass
timeFrame: On the second moring of experiment, it lasts 10 minutes.
measure: Fat free mass
timeFrame: On the first moring of experiment, it lasts 5 minutes.
measure: Bone mass
timeFrame: On the first moring of experiment, it lasts 10 minutes.
measure: Heart rate
timeFrame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
measure: Body water, extracellular fluid and intracelluar fluid
timeFrame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Institute of Advanced Technology
state: Guangdong
Study officials:
affiliation: Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
name: John R Speakman, PhD
role: STUDY_CHAIR
References: