HealthNCT03817944
Effects of Coffee Consumption on Health Among Adults
A study testing Warm Water, Caffeinated Coffee and Decaffeinated Coffee in people with Health, run by Zhejiang University at 1 site in China.
Trial summary
The purpose of this study is to research the changes of typical thermal processing food intervention on health outcome, metabolites, and gut microbiota, in order to explore the molecular mechanism of interaction between maillard reaction associated hazards and complex food matrix, and provide scientific basis and… Read more about this study
- Who is it for?
- Ages 17 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Health
- What is being tested?
- Warm Water, Caffeinated Coffee and Decaffeinated Coffee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Non-smoking, non-occupational exposed healthy volunteers, 18.5<BMI<30 kg/m^2, were screened. If the evaluation of disease history, blood biochemistry and blood routine was normal, the volunteers were considered healthy.
Who cannot join
- The main exclusion criteria included people with high exposure to cold and fever, recent drug intake (including dietary supplement intake), alcohol intake, vegetarians, pregnancy, high-temperature processed meat and beverages such as coffee and milk tea.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placebo-controlled Study on Intervention Effect of Coffee on Glucose and Lipid Homeostasis Disorders
The purpose of this study is to research the changes of typical thermal processing food intervention on health outcome, metabolites, and gut microbiota, in order to explore the molecular mechanism of interaction between maillard reaction associated hazards and complex food matrix, and provide scientific basis and reference model for combining food nutrition and safety protection.
- Conditions
- Health
- Being tested
- Warm Water, Caffeinated Coffee, Decaffeinated Coffee
- Keywords
- body weight, glucose, lipid, metabolites, gut microbiota
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm WaterOther
300 mL Warm Water per day for 8 weeks
Caffeinated CoffeeOther
300 mL Caffeinated Coffee per day for 8 weeks
Decaffeinated CoffeeOther
300 mL Decaffeinated Coffee per day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Warm Water | Placebo comparator | 300 mL Warm Water per day for 8 weeks Receives: Other: Warm Water |
| Caffeinated Coffee | Experimental | 300 mL Caffeinated Coffee per day for 8 weeks Receives: Other: Caffeinated Coffee |
| Decaffeinated Coffee | Experimental | 300 mL Decaffeinated Coffee per day for 8 weeks Receives: Other: Decaffeinated Coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose from baseline
Measured: 8 weeks
Change in blood lipids from baseline
Measured: 8 weeks
Secondary outcomes (3)
Urinary biomarkers levels of acrylamide, furans, and furfuryl alcohol
Urinary levels of environmental pollutants (e.g., acrylamide, furans, and furfuryl alcohol), measured using liquid chromatography-mass spectrometry (LC-MS)
Measured: 8 weeks; 24 hours
Change of metabolites
Measured: 8 weeks
Change in gut microbiota
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start18 Oct 2021
- Primary completion18 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Zhang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817944
- Sponsor's protocol ID
- RCT-Coffee
- Status last verified
- May 2025
- First submitted
- 23 Jan 2019
- Last updated
- 6 May 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 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled Study on Intervention Effect of Coffee on Glucose and Lipid Homeostasis Disorders
- ClinicalTrials.gov ID
- NCT03817944
- Acronym / sponsor ID
- RCT-Coffee
- Conditions
- Health
- Keywords
- body weight, glucose, lipid, metabolites, gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Jan 2019 (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 research the changes of typical thermal processing food intervention on health outcome, metabolites, and gut microbiota, in order to explore the molecular mechanism of interaction between maillard reaction associated hazards and complex food matrix, and provide scientific basis and reference model for combining food nutrition and safety protection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Warm Water | Placebo comparator | Other: Warm Water300 mL Warm Water per day for 8 weeks |
| Caffeinated Coffee | Experimental | Other: Caffeinated Coffee300 mL Caffeinated Coffee per day for 8 weeks |
| Decaffeinated Coffee | Experimental | Other: Decaffeinated Coffee300 mL Decaffeinated Coffee per day for 8 weeks |
Who may qualify
- Ages
- 17 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Non-smoking, non-occupational exposed healthy volunteers, 18.5<BMI<30 kg/m^2, were screened. If the evaluation of disease history, blood biochemistry and blood routine was normal, the volunteers were considered healthy.
Key exclusion criteria (1 listed)
- The main exclusion criteria included people with high exposure to cold and fever, recent drug intake (including dietary supplement intake), alcohol intake, vegetarians, pregnancy, high-temperature processed meat and beverages such as coffee and milk tea.
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 |
|---|---|---|
| Warm Water300 mL Warm Water per day for 8 weeks | Other | Warm Water |
| Caffeinated Coffee300 mL Caffeinated Coffee per day for 8 weeks | Other | Caffeinated Coffee |
| Decaffeinated Coffee300 mL Decaffeinated Coffee per day for 8 weeks | Other | Decaffeinated Coffee |
Primary outcome
Change in blood glucose from baseline
Time frame: 8 weeks
Change in blood lipids from baseline
Time frame: 8 weeks
3 secondary outcomes
Urinary biomarkers levels of acrylamide, furans, and furfuryl alcohol
Time frame: 8 weeks; 24 hours
Change of metabolites
Time frame: 8 weeks
Change in gut microbiota
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm Water, Caffeinated Coffee and Decaffeinated Coffee in people with Health, run by Zhejiang University 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: finished, as of the sponsor's last update on 6 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood glucose from baseline (time frame: 8 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 6 May 2025.