HealthyNCT01832701
Coffee, Exercise, and Oxidative Stress
A study testing Coffee in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Coffee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2012to 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Normal and overweight subjects (BMI 19 - 29), with lean mass below the 90th percentile value
- Coffee drinkers with an average consumption of 1-3 cups per day
- Having given informed consent
- VO2 max as a function of age and gender, not higher than the values below:
- Max oxygen uptake (VO2max, in ml/kg/min) in non athletes Age Males Females 20-29 49 41 30-39 47 39 40-49 45 37
Who cannot join
- Digestive (intestinal, gastric, hepatic or pancreatic), renal or metabolic disease, as determined by the medical (screening) visit and a blood chemistry analysis (glucose, cholesterol, LDL, HDL, triglycerides, aspartate transaminase (ASAT), Alanine transaminase (ALAT), C reactive Protein (CRP), creatinin)
- Subjects at cardio-vascular risk rated as intermediate or high (according to the Swiss Society of Cardiology, lipids group (www.agla.ch/p11-1-2.html), meaning those who show at least one of the following criteria:
- History of coronary disease / atherosclerosis
- Diabetes
- High level of risk (familial hypercholesterolemia, hyperlipoproteinemia type III, hypertension)
- Metabolic syndrome defined by the presence of at least 3 out of the following criteria :
Show all 21Show fewer
- Abdominal circumference > 102 cm in men, > 88 cm in women Fasting triglycerides ≥ 1.7 mmol/l HDL-cholesterol < 1.0 mmol/l in men, < 1.3 mmol/l in women Systolic arterial blood pressure ≥ 130 mm Hg and/or diastolic arterial blood pressure ≥ 85 mm Hg Plasma glucose ≥ 6.1 mmol/l
- Anemia (Erythrocytes < 4.6 T/l (male) or < 4.2 T/l (women); Hemoglobin Hb < 13 g/dl (male) or Hb < 12 g/dl (women); Hematocrit Ht < 40% (male) or Ht < 37% (women); sera iron < 0.6 mg/l or plasma ferritin < 120 microg /l (male) or < 60 microg/l (non menopausal women)
- Troubles of hemostasis as determined by platelets number, prothrombin time and activated partial thromboplastin time
- Have had a gastrointestinal surgery, except appendicectomy
- Pregnancy
- History of food or medication allergy
- Have a regular consumption of medication (only those impacting oxidative stress biomarkers (eg. impacting the metabolism of lipids / LDL / VLDL), oral contraception excepted)
- Have taken antibiotic therapy within the last 3 months
- Smokers (more than 5 cigarettes per day)
- Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
- Have a high alcohol consumption (more than 2 drinks/day)
- Taking more than 3 cups of coffee per day
- Consumption of illicit drugs
- Subject who cannot be expected to comply with the study procedures, including consuming the test products.
- Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinical Development Unit / Metabolic Unit
Lausanne, 1000
About this study
Official title: Coffee and Oxidative Stress During Exercise in Healthy 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 (14d) coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and plasma after an acute stress caused by exercise.
Read the detailed description
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. However, even if chlorogenic acids are known to be antioxidants in the cup, reliable evidence remains to be observed in vivo.
After medical examination and approval, subjects will undergo 2 periods of 21 days. The first 7 days will consist of a dietary restriction to lower the polyphenols intake. Then subjects will drink at random one of the three treatments for 14 days (4 cups/day). Blood and urine samples will be collected throughout the study to evaluate in vivo effects on oxidative biomarkers. Furthermore, at day 21, subjects will undergo a physical regimen to increase acutely and transiently their oxidative damage. Blood and urine samples collected throughout this challenge will allow us to evaluate the effect of coffee intake in reducing oxidative damage created by exercise compared to placebo.
- Conditions
- Healthy
- Being tested
- Coffee, Placebo comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoffeeOther
coffee versus placebo
Placebo comparatorOther
maltodextrine with caffeine
| Study group | Role | What they receive |
|---|---|---|
| coffee | Experimental | 4 cups of soluble coffee per day (2.5g per cup) Receives: Other: Placebo comparator |
| Maltodextrine with caffeine | Placebo comparator | 4 cups per day containing 2.5 g of product each Receives: Other: Coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxidative stress
Oxidative stress will be assessed though urine beta-isoprostane measurements
Measured: Change in oxidative stress from baseline to the last day of a 14-day period of product intake
Secondary outcomes (1)
Bioavailability of coffee antioxidative compounds
Measures of phenolic and chlorogenic acids in urine
Measured: Change in urine phenolic and chlorogenic acids from baseline to the last day of a 14-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 2012
- Primary completionFeb 2013
- 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
- 24 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, Clinical Development Unit / Metabolic Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832701
- Sponsor's protocol ID
- 10.38.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 and Oxidative Stress During Exercise in Healthy Humans
- ClinicalTrials.gov ID
- NCT01832701
- Acronym / sponsor ID
- 10.38.MET
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Feb 2013 (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 (14d) coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and plasma after an acute stress caused by exercise.
Detailed description
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. However, even if chlorogenic acids are known to be antioxidants in the cup, reliable evidence remains to be observed in vivo.
After medical examination and approval, subjects will undergo 2 periods of 21 days. The first 7 days will consist of a dietary restriction to lower the polyphenols intake. Then subjects will drink at random one of the three treatments for 14 days (4 cups/day). Blood and urine samples will be collected throughout the study to evaluate in vivo effects on oxidative biomarkers. Furthermore, at day 21, subjects will undergo a physical regimen to increase acutely and transiently their oxidative damage. Blood and urine samples collected throughout this challenge will allow us to evaluate the effect of coffee intake in reducing oxidative damage created by exercise compared to placebo.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coffee | Experimental | Other: Placebo comparator4 cups of soluble coffee per day (2.5g per cup) |
| Maltodextrine with caffeine | Placebo comparator | Other: Coffee4 cups per day containing 2.5 g of product each |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy
- Normal and overweight subjects (BMI 19 - 29), with lean mass below the 90th percentile value
- Coffee drinkers with an average consumption of 1-3 cups per day
- Having given informed consent
- VO2 max as a function of age and gender, not higher than the values below:
Key exclusion criteria (21 listed)
- Digestive (intestinal, gastric, hepatic or pancreatic), renal or metabolic disease, as determined by the medical (screening) visit and a blood chemistry analysis (glucose, cholesterol, LDL, HDL, triglycerides, aspartate transaminase (ASAT), Alanine transaminase (ALAT), C reactive Protein (CRP), creatinin)
- Subjects at cardio-vascular risk rated as intermediate or high (according to the Swiss Society of Cardiology, lipids group (www.agla.ch/p11-1-2.html), meaning those who show at least one of the following criteria:
- Abdominal circumference > 102 cm in men, > 88 cm in women Fasting triglycerides ≥ 1.7 mmol/l HDL-cholesterol < 1.0 mmol/l in men, < 1.3 mmol/l in women Systolic arterial blood pressure ≥ 130 mm Hg and/or diastolic arterial blood pressure ≥ 85 mm Hg Plasma glucose ≥ 6.1 mmol/l
- Anemia (Erythrocytes < 4.6 T/l (male) or < 4.2 T/l (women); Hemoglobin Hb < 13 g/dl (male) or Hb < 12 g/dl (women); Hematocrit Ht < 40% (male) or Ht < 37% (women); sera iron < 0.6 mg/l or plasma ferritin < 120 microg /l (male) or < 60 microg/l (non menopausal women)
- Troubles of hemostasis as determined by platelets number, prothrombin time and activated partial thromboplastin time
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 versus placebo | Other | Maltodextrine with caffeine |
| Placebo comparatormaltodextrine with caffeine | Other | coffee |
Primary outcome
oxidative stress
Time frame: Change in oxidative stress from baseline to the last day of a 14-day period of product intake
Oxidative stress will be assessed though urine beta-isoprostane measurements
1 secondary outcome
Bioavailability of coffee antioxidative compounds
Time frame: Change in urine phenolic and chlorogenic acids from baseline to the last day of a 14-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
Clinical Development Unit / Metabolic Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 6 inclusion and 21 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.
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. 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 oxidative stress from baseline to the last day of a 14-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.