HealthyNCT06432504
Variation in the Impact of Coffee on the Metabolic Rate
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
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. 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
- 100 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2024to 31 Dec 2026
- 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 18-40 years old
Who cannot join
- 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.
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
Shenzhen, Guangdong, 518055
Hannan Zhang, Bachelor, 13371016641, hnzhang2021@163.com
About this study
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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Caffeine content
- Keywords
- Coffee, Caffeine, Metabolic rate, Caffeine clearance
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 coffee with different amounts of caffeine.
| Study group | Role | What they receive |
|---|---|---|
| caffeine content 100mg | Experimental | The participants will drink 180 mls coffee Receives: Other: Caffeine content |
| caffeine content 200mg | Experimental | The participants will drink 180 mls coffee. Receives: Other: Caffeine content |
| caffeine content 300mg | Experimental | The participants will drink 180 mls coffee Receives: Other: Caffeine content |
| 13C3 caffeine content 100mg | Experimental | The participants will drink 180 mls coffee (caffeine content 100mg) containing 13C labelled caffeine to trace the pattern of caffeine degradation. Receives: Other: Caffeine content |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Urine metabolites
The contents of metabolites will be measured by gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS ).
Measured: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
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.
Measured: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Secondary outcomes (11)
Body temperature
Body temperature of participants will be measured by body temperature patch (RIT-P02-MED) before and after coffee consumption.
Measured: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
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.
Measured: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Blood samples
Venous blood collected by nurses, blood samples will be used for whole genome exon sequencing to analyze single nucleotide polymorphisms.
Measured: Baseline : empty stomach On the first moring of experiment.
Blood pressure
Systolic and diastolic blood pressure of participants will be measured by Omron digital sphygmomanometer before and after coffee consumption.
Measured: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Height
Height will be measured by seca 217 stable stadiometer.
Measured: On the first moring of experiment, it lasts 5 minutes.
Body weight
Fasting body weight will be measured by Bioimpedance Analysis (TANITA, MC-980).
Measured: On the first moring of experiment, it lasts 5 minutes.
Fat mass
Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).
Measured: On the second moring of experiment, it lasts 10 minutes.
Fat free mass
Fat free mass will be Bioimpedance Analysis (TANITA, MC-980).
Measured: On the first moring of experiment, it lasts 5 minutes.
Bone mass
Bone mass will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi).
Measured: On the first moring of experiment, it lasts 10 minutes.
Heart rate
Heart rate will be measured by Omron sphygmomanometer.
Measured: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Body water, extracellular fluid and intracelluar fluid
Body water, extracellular fluid and intracelluar fluid will be measured by Bioimpedance Analysis (TANITA, MC-980).
Measured: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start6 Mar 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (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
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 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
- NCT06432504
- Sponsor's protocol ID
- SIAT IRB 221115H0629
- Status last verified
- May 2024
- First submitted
- 2 Apr 2024
- Last updated
- 29 May 2024
- 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 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation in the Impact of Coffee on the Metabolic Rate
- ClinicalTrials.gov ID
- NCT06432504
- Acronym / sponsor ID
- SIAT IRB 221115H0629
- Conditions
- Healthy
- Keywords
- Coffee, Caffeine, Metabolic rate, Caffeine clearance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 May 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.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| caffeine content 100mg | Experimental | Other: Caffeine contentThe participants will drink 180 mls coffee |
| caffeine content 200mg | Experimental | Other: Caffeine contentThe participants will drink 180 mls coffee. |
| caffeine content 300mg | Experimental | Other: Caffeine contentThe participants will drink 180 mls coffee |
| 13C3 caffeine content 100mg | Experimental | Other: Caffeine contentThe participants will drink 180 mls coffee (caffeine content 100mg) containing 13C labelled caffeine to trace the pattern of caffeine degradation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults 18-40 years old
Key exclusion criteria (4 listed)
- 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.
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 coffee with different amounts of caffeine. | Other | 13C3 caffeine content 100mg, caffeine content 100mg, caffeine content 200mg, caffeine content 300mg |
Primary outcome
Resting energy expenditure
Time frame: 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
Time frame: 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 ).
Expired gases
Time frame: 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.
11 secondary outcomes
Body temperature
Time frame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Electrocardiogram (ECG)
Time frame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Blood samples
Time frame: Baseline : empty stomach On the first moring of experiment.
Blood pressure
Time frame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Height
Time frame: On the first moring of experiment, it lasts 5 minutes.
Body weight
Time frame: On the first moring of experiment, it lasts 5 minutes.
Fat mass
Time frame: On the second moring of experiment, it lasts 10 minutes.
Fat free mass
Time frame: On the first moring of experiment, it lasts 5 minutes.
Bone mass
Time frame: On the first moring of experiment, it lasts 10 minutes.
Heart rate
Time frame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
Body water, extracellular fluid and intracelluar fluid
Time frame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.
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 29 May 2024.
Related trials for Healthy
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
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 1 inclusion and 4 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 29 May 2024. 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 (13466654659, 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?
Resting energy expenditure (time frame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.). 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 29 May 2024.