HealthyNCT01832662
Coffee Polyphenols Antioxidants
A study testing coffee and maltodextrin enriched with caffeine in people with Healthy, run by Société des Produits Nestlé (SPN).
Trial summary
Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic acids) and bioavailability of these bioactive compounds is now somewhat well understood. In addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence remains to be observed in vivo. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- coffee and maltodextrin enriched with caffeine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jun 2013
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 - 70 years, male and female
- healthy
- BMI 19 - 29 kg/m2
- Coffee drinkers with an average consumption of 1-3 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
- Smokers (more than 5 cigarettes per day)
Show all 9Show fewer
- 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
About this study
Official title: Coffee Antioxidant Efficacy in Humans
Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic acids) and bioavailability of these bioactive compounds is now somewhat well understood. In addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence remains to be observed in vivo. The objective of this trial is to understand if regular (10d) coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and plasma. A secondary objective is to understand if polyphenols isolated from coffee may be as beneficial as the whole beverage in reducing oxidative stress compared to placebo
Read the detailed description
This is an interventional study with a crossover randomized placebo-controlled double-blind design to assess the effect of regular consumption of coffee on oxidative stress compared to placebo.
- Conditions
- Healthy
- Being tested
- coffee, coffee polyphenols mixed with placebo, maltodextrin enriched with caffeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coffeeOther
coffee, placebo enriched with polyphenols and placebo with caffeine
coffee polyphenols mixed with placeboOther
coffee polyphenols mixed with placebo
maltodextrin enriched with caffeineOther
maltodextrin enriched with caffeine
| Study group | Role | What they receive |
|---|---|---|
| Coffee | Experimental | 4 cups/day of 2.5g of coffee each Receives: Other: coffee polyphenols mixed with placebo; Other: maltodextrin enriched with caffeine |
| coffee polyphenols mixed with placebo | Active comparator | 4 cups/day of 2.5g of product each Receives: Other: coffee; Other: maltodextrin enriched with caffeine |
| maltodextrin enriched with caffeine | Placebo comparator | 4 cups/day of 2.5g of product each Receives: Other: coffee; Other: coffee polyphenols mixed with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxidative stress
The level of oxidative stress will be assessed through measurements of urine and plasma beta isoprostane
Measured: Change in plasma and in urine beta isoprostane from baseline to the last day of a 10-day period of product intake
Secondary outcomes (1)
bioavailability of coffee phenolics
plasma kinetics of chlorogenic and phenolic acids.
Measured: Change of plasma chrorogenic and phenolic acids from baseline to the last day of a 10-day period of product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startMar 2011
- Primary completionApr 2012
- Study completionJun 2013
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurice Beaumont, MD, Principal investigator, Nestlé Clinical Development Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832662
- Sponsor's protocol ID
- 10.07.MET
- Status last verified
- Apr 2014
- First submitted
- 8 Apr 2013
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coffee Antioxidant Efficacy in Humans
- ClinicalTrials.gov ID
- NCT01832662
- Acronym / sponsor ID
- 10.07.MET
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Apr 2013 (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 is one of the most widely consumed beverages. It contains polyphenols (chlorogenic acids) and bioavailability of these bioactive compounds is now somewhat well understood. In addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence remains to be observed in vivo. The objective of this trial is to understand if regular (10d) coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and plasma. A secondary objective is to understand if polyphenols isolated from coffee may be as beneficial as the whole beverage in reducing oxidative stress compared to placebo
Detailed description
This is an interventional study with a crossover randomized placebo-controlled double-blind design to assess the effect of regular consumption of coffee on oxidative stress compared to placebo.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coffee | Experimental | Other: coffee polyphenols mixed with placebo, Other: maltodextrin enriched with caffeine4 cups/day of 2.5g of coffee each |
| coffee polyphenols mixed with placebo | Active comparator | Other: coffee, Other: maltodextrin enriched with caffeine4 cups/day of 2.5g of product each |
| maltodextrin enriched with caffeine | Placebo comparator | Other: coffee, Other: coffee polyphenols mixed with placebo4 cups/day of 2.5g of product each |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 20 - 70 years, male and female
- healthy
- BMI 19 - 29 kg/m2
- Coffee drinkers with an average consumption of 1-3 cups per day
- having given informed consent
Key exclusion criteria (9 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
- Alcohol consumption > 2 units a day
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 |
|---|---|---|
| coffeecoffee, placebo enriched with polyphenols and placebo with caffeine | Other | coffee polyphenols mixed with placebo, maltodextrin enriched with caffeine |
| coffee polyphenols mixed with placebocoffee polyphenols mixed with placebo | Other | Coffee, maltodextrin enriched with caffeine |
| maltodextrin enriched with caffeinemaltodextrin enriched with caffeine | Other | Coffee, coffee polyphenols mixed with placebo |
Primary outcome
oxidative stress
Time frame: Change in plasma and in urine beta isoprostane from baseline to the last day of a 10-day period of product intake
The level of oxidative stress will be assessed through measurements of urine and plasma beta isoprostane
1 secondary outcome
bioavailability of coffee phenolics
Time frame: Change of plasma chrorogenic and phenolic acids from baseline to the last day of a 10-day period of product intake
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 21 Apr 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, MD principal investigator
Nestlé Clinical Development Unit
Questions about this trial
What is this clinical trial studying?
A study testing coffee and maltodextrin enriched with caffeine in people with Healthy, run by Société des Produits Nestlé (SPN).
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 9 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
oxidative stress (time frame: Change in plasma and in urine beta isoprostane from baseline to the last day of a 10-day period of product intake). 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 21 Apr 2014.