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Sponsors and Collaborators: |
TNO Quality of Life Kraft Foods |
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Information provided by: | TNO Quality of Life |
ClinicalTrials.gov Identifier: | NCT00868205 |
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.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Dietary Supplement: Coffee consumption |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Relationship Between Short- and Mid-Term Intake of Coffee on in Vivo Levels of Oxidative Stress Parameters in Healthy Adults. |
Estimated Enrollment: | 180 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
low coffee dose: Experimental
3 cups of coffee daily for 8 weeks
|
Dietary Supplement: Coffee consumption
3 or 5 cups of coffee daily for eight weeks
|
high coffee dose: Experimental
5 cups of coffee daily for eight weeks
|
Dietary Supplement: Coffee consumption
3 or 5 cups of coffee daily for eight weeks
|
Control: No Intervention
Consumption of water instead of coffee daily for eight weeks
|
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.
Ages Eligible for Study: | 35 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy as assessed by the
Exclusion Criteria:
Subjects with one or more of the following characteristics will be excluded from participation:
Contact: Wilrike Pasman, PhD | +31 30 69 44 920 | wilrike.pasman@tno.nl |
Contact: Henk Hendriks, PhD | +31 30 69 44 294 | henk.hendriks@tno.nl |
Netherlands, Utrecht | |
TNO Quality of Life | Recruiting |
Zeist, Utrecht, Netherlands, 3700 AJ | |
Contact: Wilrike Pasman, PhD +31 30 69 44 920 wilrike.pasman@tno.nl | |
Principal Investigator: Wilrike Pasman, PhD |
Principal Investigator: | Wilrike Pasman, PhD | TNO Quality of Life |
Responsible Party: | Kraft Foods Inc ( Thomas Hatzold, PhD ) |
Study ID Numbers: | P8353 |
Study First Received: | March 23, 2009 |
Last Updated: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00868205 History of Changes |
Health Authority: | The Netherlands: Centrale Commissie Medisch Onderzoek |
oxidative stress Comet assay antioxidants |
Antioxidants Stress Healthy |