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HealthyPhase 2NCT00868205

Coffee and In-vivo Oxidative Stress

A Phase 2 study testing Coffee consumption in people with Healthy, run by TNO at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Food and beverage intake that leads to a decrease in the level of in vivo markers of oxidative stress indicates that such foods and beverages act as antioxidants (AOX) in humans. Read more about this study

Who is it for?
Ages 35 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Coffee consumption
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteNetherlands
Study dates
Mar 2009to Mar 2010
Phase
Phase 2
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 35 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy as assessed by the
  • health and lifestyle questionnaire, (P8353 F02; in Dutch)
  • results of the pre-study laboratory tests
  • Males and females aged >= 35 and <= 65 years at Week 01 of the study
  • Body Mass Index (BMI) >= 20.0 but <= 34.9 kg/m2
  • Blood pressure (automated measurement at site): systolic blood pressure <= 139 mm Hg and diastolic blood pressure <= 89 mm Hg
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  • Fasting glucose <= 6.9 mmol/L
  • No smoking or moderate smoking of 1 to 19 cigarettes per day, with the proportion of smokers and nonsmokers representative of the European adult population aged 35-65 years
  • Normal European eating habits as assessed by P8353 F02. Fruit and vegetable consumption at a level representative or less for the European population as assessed by P8353 F06
  • Habitual caffeinated coffee drinker who consumes > 1 cup per day on at least 5 days per week as assessed by P8353 F02
  • Voluntary participation
  • Having given written informed consent
  • Willing to comply with the study procedures
  • Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
  • Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.

Who cannot join

  • Subjects with one or more of the following characteristics will be excluded from participation:
  • Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
  • Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
  • Having a history of medical or surgical events that may significantly affect the study outcome (including cardiovascular disease or hypertension at repeated measurements, hypercholesterolemia, hyperglycaemia, kidney or liver disease, cancer, mental illness) based on the health questionnaire
  • Hypertension as indicated by a systolic BP >= 140 mm Hg or a diastolic BP >= 90 mm Hg
  • Hypercholesterolemia as indicated by a fasting LDL-cholesterol >= 4.9 mmol/L at a single screening visit or the use of anti-hypercholesterolemia drugs
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  • Diabetes as indicated by a fasting blood glucose >= 7.0 mmol/L at a single screening visit
  • Having (a history of) (severe) gastro-intestinal complaints
  • Using medication for high blood pressure, high cholesterol level, gastro-intestinal complaints, or antidepressants. With the exception of medication for heartburn
  • Not willing to give up the use of coffee, tea, dark chocolate (and foods/beverages containing dark chocolate), vitamin supplements, mineral supplements, herbal products (food, beverage, or supplements), antioxidant dietary supplements, omega-3 fatty acid supplements including flaxseed oil and fish oil supplements, red wine or rose wines, port, sherry, or specific fortified foods
  • Not willing to give up the consumption of coffee beans as food or in foods or the consumption of coffee or espresso in foods (e.g. Tiramisu)
  • The use of any non-study caffeinated/decaffeinated coffee beverage or caffeinated/decaffeinated espresso-based beverage (espresso, cappuccino, latte, frappuccino, or frappe
  • Alcohol consumption > 28 units/week for males and > 21 units/week for females
  • Eating lots of fruit and vegetables (i.e. more than 400 gram vegetables per day and more than 4 servings of fruit per day at screening and during the study. This is twice that of the Dutch dietary recommendations for fruit and vegetable intake)
  • Changing smoking habits (> 5 cigarettes per day)
  • Exercising heavily (> 7 hours/week)
  • Not willing to give up supplement (antioxidant containing) use (to be specified)
  • Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
  • Reported slimming or medically prescribed diet
  • Reported vegan, vegetarian or macrobiotic
  • Recent blood donation (<1 month prior to the start of the study)
  • Not willing to give up blood donation during the study.
  • Pregnant or lactating or wishing to become pregnant in the period of the study
  • Personnel of TNO Quality of Life, their partner and their first and second degree relatives
  • Not having a general practitioner
  • Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • TNO Quality of Life

    Zeist, Utrecht, 3700 AJ

Other trials in Netherlands

About this study

Official title: The Relationship Between Short- and Mid-term Intake of Coffee on in Vivo Levels of Oxidative Stress Parameters in Healthy Adults.

Food and beverage intake that leads to a decrease in the level of in vivo markers of oxidative stress indicates that such foods and beverages act as antioxidants (AOX) in humans. Coffee drinking at a high level (> 900 ml/day) for a short period of time (1 week) has been shown to reduce DNA oxidative damage-as indicated by a decrease in the level of percent tail DNA (%T)- in study populations comprised mainly of young adults aged < 30 years. It is not clear whether such findings remain present over a longer period of time, and to extend such findings across a population that is more representative of European adults who consume common daily intakes of coffee, which is a low-to-moderate daily intake level (< 750 ml/day). As such, the investigators propose to determine the effect of drinking 3 and 5 cups of coffee per day (equivalent to 450 and 750 ml per day, respectively) for 8-weeks on markers of in vivo oxidative stress relative to control in a population of healthy adults free of chronic diseases aged 35 to 65 years. To ensure that overall health is considered, the investigators will also evaluate the effect on markers of cardiovascular health, inflammation, and glycemic control.

Read the detailed description

Objective: The main objective of the present study is to determine the short- and mid-term effects of a coffee, on oxidative stress parameters in humans.

Study design: randomized, placebo-controlled, investigator-blinded, 3-arm parallel Study population: 168 apparently healthy volunteers: males and females aged >=35 and <= 65 years.

Intervention: The treatments consist of daily consumption of either:

Treatment 1: 0.45 L coffee (3 cups) and 0.30 L bottled water daily or; Treatment 2: 0.75 L coffee (5 cups) daily or; Treatment 3: 0.75 L water daily Duration of the treatment intervention is 8 weeks. Before the intervention period starts, a run-in period of five weeks where all subjects maintain their low antioxidant diet (Dutch average) is conducted by all subjects in order to standardize the antioxidant intake of the subjects.

Main study parameters/endpoints: Mean level of %T as a measure of DNA oxidative damage at week 8. Secondary outcome is the mean level of 8-isoprostane in 24 hr urine.

Conditions
Healthy
Being tested
Coffee consumption
Keywords
oxidative stress, Comet assay, antioxidants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coffee consumptionDietary supplement

    3 or 5 cups of coffee daily for eight weeks

Study groups in NCT00868205
Study groupRoleWhat they receive
low coffee doseExperimental3 cups of coffee daily for 8 weeks
Receives: Dietary Supplement: Coffee consumption
high coffee doseExperimental5 cups of coffee daily for eight weeks
Receives: Dietary Supplement: Coffee consumption
ControlNo interventionConsumption of water instead of coffee daily for eight weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DNA oxidative damage (Comet assay, %T)

    Measured: week 0, 4, 5,6,9 and 13

Secondary outcomes (1)

  1. Lipid oxidative damage (8-isoprostane in urine)

    Measured: week 5,6,9,13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionJul 2009
  4. Study completionMar 2010

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00868205
Sponsor's protocol ID
P8353
Status last verified
Feb 2012
First submitted
23 Mar 2009
Last updated
28 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • Bichler J, Cavin C, Simic T, Chakraborty A, Ferk F, Hoelzl C, Schulte-Hermann R, Kundi M, Haidinger G, Angelis K, Knasmuller S. Coffee consumption protects human lymphocytes against oxidative and 3-amino-1-methyl-5H-pyrido[4,3-b]indole acetate (Trp-P-2) induced DNA-damage: results of an experimental study with human volunteers. Food Chem Toxicol. 2007 Aug;45(8):1428-36. doi: 10.1016/j.fct.2007.02.001. Epub 2007 Feb 12.

    PubMed 17376579

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Coffee consumption in people with Healthy, run by TNO at 1 site in Netherlands.

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 15 inclusion and 26 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 28 Feb 2012. 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 Netherlands. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

DNA oxidative damage (Comet assay, %T) (time frame: week 0, 4, 5,6,9 and 13). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00868205, which also lists 1 linked publication.

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 28 Feb 2012.

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