HealthyNCT06712667
The Effect of Coffee on People with High Intensity Exercise and the Characteristics of 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
The purpose of this project is to explore the relationship between the effect of coffee on exercise performance and caffeine metabolism. 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?
- Yes, some participants may receive a placebo
- How many people
- 24 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 18-40 years old
Who cannot join
- Diabetes Hypoglycemia Gout Osteoporosis Gastric ulcer Pancreatitis 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
The purpose of this project is to explore the relationship between the effect of coffee on exercise performance and caffeine metabolism.
Read the detailed description
The investigators will study the relationship between the impact of coffee on exercise and caffeine metabolism. The investigators will recruit healthy elite athletes. 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. Each participant does six rides, with one day of caffeine washout before each ride. In all trials, each participant will ride at the same time of day. Before riding, drink 200 ml water, decaffeinated coffee or coffee in random order, and the caffeine content of coffee is 200 mg. After 60 minutes of drinking, they start riding, after the completion of the riding, the subjects perceived and judged the perception between the baseline load and the comparison load. After the completion of the judgment, the next level of stimulus parameters will randomly generated to conduct the experiment. Each person conducted 6 groups of intervention experiments. Changes in average exercise performance, heart rate, electrocardiogram and body temperature will be observed after drinking decaffeinated coffee or coffee compared with drinking water. The concentration of caffeine and its metabolites in urine before and after drinking within 3 hours will be measured by liquid chromatography-mass spectrometry (LC-MS) or gas chromatography-mass spectrometry (GC-MS).
- Conditions
- Healthy
- Being tested
- Caffeine content
- Keywords
- Coffee, Caffeine, Exercise, Caffeine metabolism
- Medical subject headings
- Motor Activity
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 with different amounts of caffeine.
| Study group | Role | What they receive |
|---|---|---|
| Water | Placebo comparator | The participants will drink 200 ml water. Receives: Other: Caffeine content |
| Decaffeinated coffee | Experimental | The participants will drink 200 ml decaffeinated coffee. Receives: Other: Caffeine content |
| Coffee | Experimental | The participants will drink 200 ml coffee, the caffeine content is 200 mg. Receives: Other: Caffeine content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise performance
After the completion of the riding, the subjects perceived and judged the perception between the baseline load and the comparison load.
Measured: On the experimental day, it lasts 2 weeks.
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 experimental day, it lasts 2 weeks.
Secondary outcomes (10)
Body temperature
Body temperature of participants will be measured by ear temperature gun.
Measured: On the experimental day, it lasts 2 weeks.
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: On the experimental day, it lasts 2 weeks.
Blood pressure
Systolic and diastolic blood pressure of participants will be measured by Omron digital sphygmomanometer.
Measured: On the experimental day, it lasts 2 weeks.
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 measured by Bioimpedance Analysis (Tanita, MC-980).
Measured: The morning of the first day of the experiment, 10 mins
Bone mass
Bone mass will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi).
Measured: The morning of the first day of the experiment, 10 mins
Heart rate
Heart rate will be measured by heart rate belt.
Measured: 2 weeks
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
- 24 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
- NCT06712667
- Sponsor's protocol ID
- SIAT IRB240915H0915
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Coffee on People with High Intensity Exercise and the Characteristics of Caffeine Metabolism
- ClinicalTrials.gov ID
- NCT06712667
- Acronym / sponsor ID
- SIAT IRB240915H0915
- Conditions
- Healthy
- Keywords
- Coffee, Caffeine, Exercise, Caffeine metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 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.
The purpose of this project is to explore the relationship between the effect of coffee on exercise performance and caffeine metabolism.
Detailed description
The investigators will study the relationship between the impact of coffee on exercise and caffeine metabolism. The investigators will recruit healthy elite athletes. 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. Each participant does six rides, with one day of caffeine washout before each ride. In all trials, each participant will ride at the same time of day. Before riding, drink 200 ml water, decaffeinated coffee or coffee in random order, and the caffeine content of coffee is 200 mg. After 60 minutes of drinking, they start riding, after the completion of the riding, the subjects perceived and judged the perception between the baseline load and the comparison load. After the completion of the judgment, the next level of stimulus parameters will randomly generated to conduct the experiment. Each person conducted 6 groups of intervention experiments. Changes in average exercise performance, heart rate, electrocardiogram and body temperature will be observed after drinking decaffeinated coffee or coffee compared with drinking water. The concentration of caffeine and its metabolites in urine before and after drinking within 3 hours will be measured by liquid chromatography-mass spectrometry (LC-MS) or 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Water | Placebo comparator | Other: Caffeine contentThe participants will drink 200 ml water. |
| Decaffeinated coffee | Experimental | Other: Caffeine contentThe participants will drink 200 ml decaffeinated coffee. |
| Coffee | Experimental | Other: Caffeine contentThe participants will drink 200 ml coffee, the caffeine content is 200 mg. |
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 (1 listed)
- Diabetes Hypoglycemia Gout Osteoporosis Gastric ulcer Pancreatitis Intestinal obstruction Blood phobia Pathological hypo or hyper tension Impaired glucose tolerance Claustrophobia HIV,etc.
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 with different amounts of caffeine. | Other | Coffee, Decaffeinated coffee, Water |
Primary outcome
Exercise performance
Time frame: On the experimental day, it lasts 2 weeks.
After the completion of the riding, the subjects perceived and judged the perception between the baseline load and the comparison load.
Urine metabolites
Time frame: On the experimental day, it lasts 2 weeks.
The contents of metabolites will be measured by gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS ).
10 secondary outcomes
Body temperature
Time frame: On the experimental day, it lasts 2 weeks.
Electrocardiogram (ECG)
Time frame: On the experimental day, it lasts 2 weeks.
Blood pressure
Time frame: On the experimental day, it lasts 2 weeks.
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: The morning of the first day of the experiment, 10 mins
Bone mass
Time frame: The morning of the first day of the experiment, 10 mins
Heart rate
Time frame: 2 weeks
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 26 Feb 2025.
- Individual participant dataSharing planned: No
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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 1 inclusion and 1 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 26 Feb 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. Some participants in this study may receive a placebo. 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?
Exercise performance (time frame: On the experimental day, it lasts 2 weeks.). The study lists 2 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 26 Feb 2025.