Variation in the Impact of Coffee on the Metabolic Rate

Healthy Clinical Trial

Official title:

Variation in the Impact of Coffee on the Metabolic Rate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06432504
• Other study ID #: SIAT IRB 221115H0629
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
• Contact: John R Speakman, PhD
• Phone: 13466654659
• Email: j.speakman[@]abdn.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Caffeine content
Participants will drink the same volume of coffee with different amounts of caffeine.

Locations

Country	Name	City	State
China	Shenzhen Institute of Advanced Technology	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting energy expenditure	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.	On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Primary	Urine metabolites	The contents of metabolites will be measured by gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS ).	On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Primary	Expired gases	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.	On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Secondary	Body temperature	Body temperature of participants will be measured by body temperature patch (RIT-P02-MED) before and after coffee consumption.	On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Secondary	Electrocardiogram (ECG)	ECG of participants will be measured by Amu ECG belt before and after coffee consumption, the changes in P wave, PR interval, PR segment, QRS wave group, J point, ST segment, T wave, QT interval, and U wave will be observe.	On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Secondary	Blood samples	Venous blood collected by nurses, blood samples will be used for whole genome exon sequencing to analyze single nucleotide polymorphisms.	Baseline : empty stomach On the first moring of experiment.
Secondary	Blood pressure	Systolic and diastolic blood pressure of participants will be measured by Omron digital sphygmomanometer before and after coffee consumption.	On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Secondary	Height	Height will be measured by seca 217 stable stadiometer.	On the first moring of experiment, it lasts 5 minutes.
Secondary	Body weight	Fasting body weight will be measured by Bioimpedance Analysis (TANITA, MC-980).	On the first moring of experiment, it lasts 5 minutes.
Secondary	Fat mass	Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).	On the second moring of experiment, it lasts 10 minutes.
Secondary	Fat free mass	Fat free mass will be Bioimpedance Analysis (TANITA, MC-980).	On the first moring of experiment, it lasts 5 minutes.
Secondary	Bone mass	Bone mass will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi).	On the first moring of experiment, it lasts 10 minutes.
Secondary	Heart rate	Heart rate will be measured by Omron sphygmomanometer.	On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Secondary	Body water, extracellular fluid and intracelluar fluid	Body water, extracellular fluid and intracelluar fluid will be measured by Bioimpedance Analysis (TANITA, MC-980).	On the first moring of experiment, it lasts 0.5 hours and 3 hours.