Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-27 @ 10:42 AM
Study NCT ID:
NCT00868205
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2009-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coffee and In-vivo Oxidative Stress
Sponsor:
TNO
Organization:
Study Overview
Official Title:
The Relationship Between Short- and Mid-term Intake of Coffee on in Vivo Levels of Oxidative Stress Parameters in Healthy Adults.
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: