The Effect of Coffee on Energy Expenditure and Caffeine Metabolism

Not Applicable

Recruiting

• Conditions: Healthy

• Registration Number: NCT06712511
• Lead Sponsor: Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

Brief Summary

Obesity is a risk factor for chronic diseases, and improving energy expenditure is a way to prevent and treat obesity. The purpose of this project is to explore the relationship between the effect of coffee on energy expenditure and caffeine metabolism, which has important significance in the rational application of caffeine.

Detailed Description

The investigators will study the relationship between the effect of coffee on energy expenditure and caffeine metabolism. The investigators will recruit healthy participants. Participants will be forbidden to consume stimulant drinks such as coffee for 24 hours before the experiment. 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. The changes of drinking water/coffee on total energy expenditure (TEE), body temperature, heart rate, blood pressure, electrocardiogram, memory，cognition, sleep time and so on will be observed. The concentration of caffeine and its metabolites in the blood and urine will be measured by liquid chromatography-mass spectrometry (LC-MS) and gas chromatography-mass spectrometry (GC-MS).

Study Timeline

• Study Start: 2024-10-23
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-12-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-27
• Primary Completion: 2029-06-30
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

• Diabetes.
• Hypoglycemia.
• Gout.
• Osteoporosis.
• Gastric ulcer.
• Pancreatitis.
• Intestinal obstruction.
• Blood phobia.
• Pathological hypo or hyper tension.
• Impaired glucose tolerance.
• Claustrophobia.
• HIV,etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total energy expenditure	2 days	Total energy expenditure will be measured by Chamber (OMNICAL).
The concentration of caffeine and its metabolites in urine	2 days	The contents of caffeine and it's metabolites will be measured by gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS ).
The concentration of caffeine and its metabolites in serum	1 day	The concentration of caffeine and its metabolites in serum will be measured by gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS ).

Secondary Outcome Measures

Name	Time	Method
Body temperature	2 days	Body temperature of participants will be measured by body temperature patch (RIT-P02-MED).
Electrocardiogram (ECG)	2 days	ECG of participants will be measured by Amu ECG belt, 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.
Blood pressure	2 days	Systolic and diastolic blood pressure of participants will be measured by Omron digital sphygmomanometer.
Height	The morning of the first day of the experiment, 5 mins	Height will be measured by seca 217 stable stadiometer. Subjects wearing no shoes.
Body weight	The morning of the first day of the experiment, 5 mins	Fasting body weight will be measured by Bioimpedance Analysis (TANITA, MC-980).
Fat mass	The morning of the first day of the experiment, 10 mins	Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).
Fat free mass	on the morning of the experiment, 5 mins	Fat free mass will be Bioimpedance Analysis (Tanita, MC-980).
Heart rate	2 days	Heart rate will be measured by Polar heart rate belts.
Hunger rating	2 days	Hunger score will be measured on (Visual Analogue Scale) VAS by a pen and a paper. According to the scores of each participant, the highest score was 100 % hunger rate, and hunger rate (%) at other time points will be obtained from hunger score × 100 % / the highest score.
Memory and cognitive tests	The morning of the experiment, 60 mins	Memory and cognitive tests will be tested by Cognitive Experiment Standard Toolbox (CEST).
Physical activity	7 days	The physical activity of volunteers will be recorded by accelerometer (GT3XP-BTLE).
Sleep duration	2 days	The sleep duration of volunteers will be recorded by polar watch.
Waist circumferences	The morning of the first day of the experiment,10 mins.	Waist circumferences will be measured using a whole body laser scanner (TG2000-F).

Trial Locations

Locations (1)

Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences; 🇨🇳 Shenzhen, Guangdong, China