Coffee Polyphenols Antioxidants

NCT ID: NCT01832662

Last Updated: 2014-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-06-30

Brief Summary

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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 (10d) coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and plasma. A secondary objective is to understand if polyphenols isolated from coffee may be as beneficial as the whole beverage in reducing oxidative stress compared to placebo

Detailed Description

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This is an interventional study with a crossover randomized placebo-controlled double-blind design to assess the effect of regular consumption of coffee on oxidative stress compared to placebo.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Coffee

4 cups/day of 2.5g of coffee each

Group Type EXPERIMENTAL

coffee polyphenols mixed with placebo

Intervention Type OTHER

coffee polyphenols mixed with placebo

maltodextrin enriched with caffeine

Intervention Type OTHER

maltodextrin enriched with caffeine

coffee polyphenols mixed with placebo

4 cups/day of 2.5g of product each

Group Type ACTIVE_COMPARATOR

coffee

Intervention Type OTHER

coffee, placebo enriched with polyphenols and placebo with caffeine

maltodextrin enriched with caffeine

Intervention Type OTHER

maltodextrin enriched with caffeine

maltodextrin enriched with caffeine

4 cups/day of 2.5g of product each

Group Type PLACEBO_COMPARATOR

coffee

Intervention Type OTHER

coffee, placebo enriched with polyphenols and placebo with caffeine

coffee polyphenols mixed with placebo

Intervention Type OTHER

coffee polyphenols mixed with placebo

Interventions

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coffee

coffee, placebo enriched with polyphenols and placebo with caffeine

Intervention Type OTHER

coffee polyphenols mixed with placebo

coffee polyphenols mixed with placebo

Intervention Type OTHER

maltodextrin enriched with caffeine

maltodextrin enriched with caffeine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 20 - 70 years, male and female
* healthy
* BMI 19 - 29 kg/m2
* Coffee drinkers with an average consumption of 1-3 cups per day
* having given informed consent

Exclusion Criteria

* Intestinal or metabolic diseases / disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer- Have had a gastrointestinal surgery, except appendicectomy
* Difficulty to swallow
* Have a regular consumption of medication
* Have taken antibiotic therapy within the last 6 months
* Alcohol consumption \> 2 units a day
* Smokers (more than 5 cigarettes per day)
* Have given blood within the last 3 weeks
* Volunteers who cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial during the last 3 weeks
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maurice Beaumont, MD

Role: PRINCIPAL_INVESTIGATOR

Nestlé Clinical Development Unit

Other Identifiers

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10.07.MET

Identifier Type: -

Identifier Source: org_study_id

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