HealthyNCT01523028
Influence of Breakfast Consumption on Chlorogenic Acid Metabolism in Humans
A study testing Soluble Coffee in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Germany.
Trial summary
Data and knowledge gathered on bioavailability of coffee phenolics is becoming more and more important, hence underlying the importance of better understanding the fate of these potential health promoting antioxidants. Read more about this study
- Who is it for?
- Ages 20 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Soluble Coffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to Dec 2012
- 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 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Aged 20-44 years
- Caucasian origin
- Body mass index (BMI) 19-25 kg/m2
- Used to drinking coffee (similar to study coffee) on a daily basis
- Being able to tolerate a 48-hour coffee abstinence
- Normal oral glucose tolerance test
- Having signed the informed consent form
Who cannot join
- Taking medication or dietary supplements
- Smoking
- Performing a competitive sport
- Having metabolic disorders
- Long gut transit time (>24 h)
- Blood donor
Show all 10Show fewer
- Irregularity in menstrual cycle (for women)
- Pregnancy (for women)
- Subject who cannot be expected to comply with the study procedures.
- Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Data and knowledge gathered on bioavailability of coffee phenolics is becoming more and more important, hence underlying the importance of better understanding the fate of these potential health promoting antioxidants. However, some analytical barriers as well as some key aspects of metabolism still remain to be fully elucidated to get the full picture of coffee metabolism and bioavailability. One aspect addressed in the present study is the impact of food matrix in modulating absorption, plasma appearance and urinary excretion of coffee bioactives.
- Conditions
- Healthy
- Being tested
- Soluble Coffee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble CoffeeOther
Amounts of chlorogenic acids will be normalized to body weight (3.1 mg CA / kg BW). Coffee will be reconstituted in 200 mL hot water and consumed 3 times in a row (min 1-week interval), alone or with a breakfast:
- 200 mL coffee or
- 200 mL coffee + 2 bread rolls + honey
- 200 mL coffee + 1 bread roll + peanut butter
| Study group | Role | What they receive |
|---|---|---|
| Coffee, bread and honey | Experimental | 200 mL coffee + 2 bread rolls + honey Receives: Other: Soluble Coffee |
| Coffee, bread and peanut butter | Experimental | 200 mL coffee + 1 bread roll + peanut butter Receives: Other: Soluble Coffee |
| 200 mL black coffee | Experimental | Not described Receives: Other: Soluble Coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of plasma areas under the curve of coffee phenolics
Measured: Measurements over 24h after coffee ingestion
Secondary outcomes (2)
Plasma AUC, Cmax and Tmax of individually measured coffee chlorogenic and phenolic acids
Measured: Measurements done over 24h after coffee ingestion
Urinary excretion of coffee chlorogenic and phenolic acids expressed as % ingested dose
Measured: Measurements done over 24h after coffee ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionDec 2012
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
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523028
- Sponsor's protocol ID
- 11.12.NRC
- Status last verified
- Jun 2013
- First submitted
- 27 Jan 2012
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Breakfast Consumption on Chlorogenic Acid Metabolism in Humans
- ClinicalTrials.gov ID
- NCT01523028
- Acronym / sponsor ID
- 11.12.NRC
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Feb 2012 (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.
Data and knowledge gathered on bioavailability of coffee phenolics is becoming more and more important, hence underlying the importance of better understanding the fate of these potential health promoting antioxidants. However, some analytical barriers as well as some key aspects of metabolism still remain to be fully elucidated to get the full picture of coffee metabolism and bioavailability. One aspect addressed in the present study is the impact of food matrix in modulating absorption, plasma appearance and urinary excretion of coffee bioactives.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coffee, bread and honey | Experimental | Other: Soluble Coffee200 mL coffee + 2 bread rolls + honey |
| Coffee, bread and peanut butter | Experimental | Other: Soluble Coffee200 mL coffee + 1 bread roll + peanut butter |
| 200 mL black coffee | Experimental | Other: Soluble Coffee |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy men and women
- Aged 20-44 years
- Caucasian origin
- Body mass index (BMI) 19-25 kg/m2
- Used to drinking coffee (similar to study coffee) on a daily basis
Key exclusion criteria (10 listed)
- Taking medication or dietary supplements
- Smoking
- Performing a competitive sport
- Having metabolic disorders
- Long gut transit time (>24 h)
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 |
|---|---|---|
| Soluble CoffeeAmounts of chlorogenic acids will be normalized to body weight (3.1 mg CA / kg BW). Coffee will be reconstituted in 200 mL hot water and consumed 3 times in a row (min 1-week interval), alone or with a breakfast: * 200 mL coffee or * 200 mL coffee + 2 bread rolls + honey * 200 mL coffee + 1 bread roll + peanut butter | Other | 200 mL black coffee, Coffee, bread and honey, Coffee, bread and peanut butter |
Primary outcome
Sum of plasma areas under the curve of coffee phenolics
Time frame: Measurements over 24h after coffee ingestion
2 secondary outcomes
Plasma AUC, Cmax and Tmax of individually measured coffee chlorogenic and phenolic acids
Time frame: Measurements done over 24h after coffee ingestion
Urinary excretion of coffee chlorogenic and phenolic acids expressed as % ingested dose
Time frame: Measurements done over 24h after coffee 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 2013.
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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 Soluble Coffee in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Germany.
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 8 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 2013. 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 Germany. 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?
Sum of plasma areas under the curve of coffee phenolics (time frame: Measurements over 24h after coffee 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 2013.