HealthyNCT01089920
Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans
A study testing Green tea and Coffee in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
Coffee and green tea are 2 widely consumed beverages. Both contain polyphenol antioxidant compounds (chlorogenic acids for coffee and catechins for tea). The bioavailability of catechins is somewhat known and has been referenced in the literature. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Green tea and Coffee
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2009to Feb 2010
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 - 65 years, male and female
- Healthy as determined by the medical questionnaire and the medical visit
- Normal weight: BMI 18 - 25
- Coffee drinkers with an average consumption of 2-5 cups per day
- Having given informed consent
Who cannot join
- Intestinal or metabolic diseases / disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer
- Have had a gastrointestinal surgery, except appendicectomy
- Difficulty to swallow
- Have a regular consumption of medication
- Have taken antibiotic therapy within the last 6 months
- Alcohol consumption > 2 units a day
Show all 10Show fewer
- Smokers (more than 5 cigarettes per day)
- Have given blood within the last 3 weeks
- Volunteers who cannot be expected to comply with treatment
- Currently participating or having participated in another clinical trial during the last 3 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Coffee and green tea are 2 widely consumed beverages. Both contain polyphenol antioxidant compounds (chlorogenic acids for coffee and catechins for tea). The bioavailability of catechins is somewhat known and has been referenced in the literature. However, bioavailability data from tea infusion is non-existent, even though it reflects better how consumers drink this beverage. In addition, bioavailability of coffee chlorogenic acids is less understood and no dose response study has been reported so far in the literature. Thus, there is a great need to understand and reinforce our knowledge on the bioavailability of coffee and tea polyphenol compounds.
- Conditions
- Healthy
- Being tested
- Green tea, Coffee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green teaOther
Infusion (tea bags) from commercially available green tea
CoffeeOther
Also called Soluble coffee
Soluble coffee commercially available
| Study group | Role | What they receive |
|---|---|---|
| High dose coffee | Experimental | High dose of polyphenols from soluble coffee Receives: Other: Coffee |
| Medium dose coffee | Experimental | Medium dose of polyphenols from soluble coffee Receives: Other: Coffee |
| Low dose coffee | Experimental | Low dose of polyphenols from soluble coffee Receives: Other: Coffee |
| High dose green tea | Experimental | High dose of green tea polyphenols from infusion Receives: Other: Green tea |
| Medium dose green tea infusion | Experimental | Medium dose of green polyphenols from infusion Receives: Other: Green tea |
| Low dose green tea infusion | Experimental | low dose of polyphenols from an infusion of green tea Receives: Other: Green tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare plasma Area under the curve (AUC) of highest and lowest dose of coffee for chlorogenic and phenolic acid metabolites
Measured: Measurements done over 24h after ingestion
Secondary outcomes (2)
Compare Area under the curve (AUC), Maximum plasma concentration (Cmax), Time to reach maximum plasma concentration (Tmax) and half-life (T1/2) of all three doses of coffee for chlorogenic and phenolic acid metabolites
Measured: Measurements done over 12h after ingestion
Compare AUC, Cmax, Tmax and T1/2 of all three doses of green tea for catechin metabolites
Measured: Measurements done over 12h after ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startSep 2009
- Primary completionFeb 2010
- Study completionFeb 2010
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.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurice Beaumont, M.D., Ph.D., Principal investigator, Nestec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089920
- Sponsor's protocol ID
- 09.06.MET
- Status last verified
- Jun 2014
- First submitted
- 18 Mar 2010
- Last updated
- 5 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans
- ClinicalTrials.gov ID
- NCT01089920
- Acronym / sponsor ID
- 09.06.MET
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 19 Mar 2010 (estimated)
- 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.
Coffee and green tea are 2 widely consumed beverages. Both contain polyphenol antioxidant compounds (chlorogenic acids for coffee and catechins for tea). The bioavailability of catechins is somewhat known and has been referenced in the literature. However, bioavailability data from tea infusion is non-existent, even though it reflects better how consumers drink this beverage. In addition, bioavailability of coffee chlorogenic acids is less understood and no dose response study has been reported so far in the literature. Thus, there is a great need to understand and reinforce our knowledge on the bioavailability of coffee and tea polyphenol compounds.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| High dose coffee | Experimental | Other: CoffeeHigh dose of polyphenols from soluble coffee |
| Medium dose coffee | Experimental | Other: CoffeeMedium dose of polyphenols from soluble coffee |
| Low dose coffee | Experimental | Other: CoffeeLow dose of polyphenols from soluble coffee |
| High dose green tea | Experimental | Other: Green teaHigh dose of green tea polyphenols from infusion |
| Medium dose green tea infusion | Experimental | Other: Green teaMedium dose of green polyphenols from infusion |
| Low dose green tea infusion | Experimental | Other: Green tealow dose of polyphenols from an infusion of green tea |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 - 65 years, male and female
- Healthy as determined by the medical questionnaire and the medical visit
- Normal weight: BMI 18 - 25
- Coffee drinkers with an average consumption of 2-5 cups per day
- Having given informed consent
Key exclusion criteria (10 listed)
- Intestinal or metabolic diseases / disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer
- Have had a gastrointestinal surgery, except appendicectomy
- Difficulty to swallow
- Have a regular consumption of medication
- Have taken antibiotic therapy within the last 6 months
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 |
|---|---|---|
| Green teaInfusion (tea bags) from commercially available green tea | Other | High dose green tea, Low dose green tea infusion, Medium dose green tea infusion |
| CoffeeAlso: Soluble coffeeSoluble coffee commercially available | Other | High dose coffee, Low dose coffee, Medium dose coffee |
Primary outcome
Compare plasma Area under the curve (AUC) of highest and lowest dose of coffee for chlorogenic and phenolic acid metabolites
Time frame: Measurements done over 24h after ingestion
2 secondary outcomes
Compare Area under the curve (AUC), Maximum plasma concentration (Cmax), Time to reach maximum plasma concentration (Tmax) and half-life (T1/2) of all three doses of coffee for chlorogenic and phenolic acid metabolites
Time frame: Measurements done over 12h after ingestion
Compare AUC, Cmax, Tmax and T1/2 of all three doses of green tea for catechin metabolites
Time frame: Measurements done over 12h after ingestion
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 5 Jun 2014.
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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.
Maurice Beaumont, M.D., Ph.D. principal investigator
Nestec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green tea and Coffee in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 5 inclusion and 10 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 5 Jun 2014. 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 Switzerland. 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?
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?
Compare plasma Area under the curve (AUC) of highest and lowest dose of coffee for chlorogenic and phenolic acid metabolites (time frame: Measurements done over 24h after ingestion). 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 5 Jun 2014.