Coffee and In-vivo Oxidative Stress

NCT00868205 | Completed Phase 2

• 1 other identifier: P8353
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

oxidative stress; Comet assay; antioxidants

Outcome Measures

Primary Outcomes (1)

• DNA oxidative damage (Comet assay, %T)

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

Secondary Outcomes (1)

• Lipid oxidative damage (8-isoprostane in urine)

  week 5,6,9,13

Study Arms (3)

low coffee dose

EXPERIMENTAL

3 cups of coffee daily for 8 weeks

Dietary Supplement: Coffee consumption

high coffee dose

EXPERIMENTAL

5 cups of coffee daily for eight weeks

Dietary Supplement: Coffee consumption

Control

NO INTERVENTION

Consumption of water instead of coffee daily for eight weeks

Interventions

Coffee consumption DIETARY_SUPPLEMENT

3 or 5 cups of coffee daily for eight weeks

high coffee dose; low coffee dose

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• TNO: lead
• Mondelēz International, Inc.: collaborator

Study Sites (1)

TNO Quality of Life

Zeist, Utrecht, 3700 AJ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 17376579 BACKGROUND

Related Links

• information about the effect of coffee on antioxidant status

Study Officials

• Wilrike Pasman, PhD

  TNO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: TNO, Zeist, The Netherlands

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 24, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: March 1, 2010
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

NL (1)