HealthyNCT06712511
The Effect of Coffee on Energy Expenditure and Caffeine Metabolism
A study testing Caffeine content in people with Healthy, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Caffeine content
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults.
- Must be able to drink coffee.
Who cannot join
- Diabetes.
- Hypoglycemia.
- Gout.
- Osteoporosis.
- Gastric ulcer.
- Pancreatitis.
Show all 12Show fewer
- Intestinal obstruction.
- Blood phobia.
- Pathological hypo or hyper tension.
- Impaired glucose tolerance.
- Claustrophobia.
- HIV,etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
Shenzhen, Guangdong, 518055
Huanan Zhang, Master, 13371016641, hnzhang2021@163.com
About this study
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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Caffeine content
- Keywords
- Coffee, Caffeine, Energy expenditure, Caffeine metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine contentOther
Participants will drink the same volume of water or coffee, caffeine content is 2mg/kg by body weight.
| Study group | Role | What they receive |
|---|---|---|
| water | Experimental | The participants will drink 200 ml water four times at 1 hour intervals. Receives: Other: Caffeine content |
| coffee | Experimental | The participants will drink 200 ml coffee four times at 1 hour intervals. Receives: Other: Caffeine content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total energy expenditure
Total energy expenditure will be measured by Chamber (OMNICAL).
Measured: 2 days
The concentration of caffeine and its metabolites in urine
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 ).
Measured: 2 days
The concentration of caffeine and its metabolites in serum
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 ).
Measured: 1 day
Secondary outcomes (13)
Body temperature
Body temperature of participants will be measured by body temperature patch (RIT-P02-MED).
Measured: 2 days
Electrocardiogram (ECG)
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.
Measured: 2 days
Blood pressure
Systolic and diastolic blood pressure of participants will be measured by Omron digital sphygmomanometer.
Measured: 2 days
Height
Height will be measured by seca 217 stable stadiometer. Subjects wearing no shoes.
Measured: The morning of the first day of the experiment, 5 mins
Body weight
Fasting body weight will be measured by Bioimpedance Analysis (TANITA, MC-980).
Measured: The morning of the first day of the experiment, 5 mins
Fat mass
Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).
Measured: The morning of the first day of the experiment, 10 mins
Fat free mass
Fat free mass will be Bioimpedance Analysis (Tanita, MC-980).
Measured: on the morning of the experiment, 5 mins
Heart rate
Heart rate will be measured by Polar heart rate belts.
Measured: 2 days
Hunger rating
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.
Measured: 2 days
Memory and cognitive tests
Memory and cognitive tests will be tested by Cognitive Experiment Standard Toolbox (CEST).
Measured: The morning of the experiment, 60 mins
Physical activity
The physical activity of volunteers will be recorded by accelerometer (GT3XP-BTLE).
Measured: 7 days
Sleep duration
The sleep duration of volunteers will be recorded by polar watch.
Measured: 2 days
Waist circumferences
Waist circumferences will be measured using a whole body laser scanner (TG2000-F).
Measured: The morning of the first day of the experiment,10 mins.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start23 Oct 2024
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John R. Speakman, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
- Investigators
- John R Speakman, PhD, Study chair, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712511
- Sponsor's protocol ID
- SIAT IRB 240715H0902
- Status last verified
- Mar 2025
- First submitted
- 26 Nov 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Coffee on Energy Expenditure and Caffeine Metabolism
- ClinicalTrials.gov ID
- NCT06712511
- Acronym / sponsor ID
- SIAT IRB 240715H0902
- Conditions
- Healthy
- Keywords
- Coffee, Caffeine, Energy expenditure, Caffeine metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| water | Experimental | Other: Caffeine contentThe participants will drink 200 ml water four times at 1 hour intervals. |
| coffee | Experimental | Other: Caffeine contentThe participants will drink 200 ml coffee four times at 1 hour intervals. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults.
- Must be able to drink coffee.
Key exclusion criteria (12 listed)
- Diabetes.
- Hypoglycemia.
- Gout.
- Osteoporosis.
- Gastric ulcer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine contentParticipants will drink the same volume of water or coffee, caffeine content is 2mg/kg by body weight. | Other | coffee, water |
Primary outcome
Total energy expenditure
Time frame: 2 days
Total energy expenditure will be measured by Chamber (OMNICAL).
The concentration of caffeine and its metabolites in urine
Time frame: 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
Time frame: 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 ).
13 secondary outcomes
Body temperature
Time frame: 2 days
Electrocardiogram (ECG)
Time frame: 2 days
Blood pressure
Time frame: 2 days
Height
Time frame: The morning of the first day of the experiment, 5 mins
Body weight
Time frame: The morning of the first day of the experiment, 5 mins
Fat mass
Time frame: The morning of the first day of the experiment, 10 mins
Fat free mass
Time frame: on the morning of the experiment, 5 mins
Heart rate
Time frame: 2 days
Hunger rating
Time frame: 2 days
Memory and cognitive tests
Time frame: The morning of the experiment, 60 mins
Physical activity
Time frame: 7 days
Sleep duration
Time frame: 2 days
Waist circumferences
Time frame: The morning of the first day of the experiment,10 mins.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John R Speakman, PhD study chair
Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine content in people with Healthy, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John R Speakman, PhD (15810868669, j.speakman@abdn.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total energy expenditure (time frame: 2 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.