Bioavailability of Chlorogenic and Phenolic Acids From Soluble Coffees

NCT ID: NCT01400386

Last Updated: 2014-05-22

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Coffee contributes to a large extent to our daily intake of phenolic compounds which have been associated with potential health benefits. A study by Richelle et al. (2001), using an LDL oxidation assay, showed that phenolic compounds in coffee possessed antioxidant activity which varied depending on the coffee bean source and the degree of roasting. Little is known about the bioavailability of phenolic compounds from coffee at various roasting degrees. Therefore, further human studies are required in order to demonstrate the absorption, and bioavailability of metabolites that may also be efficient in vivo.

The main objective of this clinical trial is to investigate the possible difference in the bioavailability of chlorogenic and phenolic acids from coffee at various roasting levels.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Coffee contributes to a large extent to our daily intake of phenolic compounds which have been associated with potential health benefits. A study by Richelle et al. (2001), using an LDL oxidation assay, showed that phenolic compounds in coffee possessed antioxidant activity which varied depending on the coffee bean source and the degree of roasting. Little is known about the bioavailability of phenolic compounds from coffee at various roast levels. Therefore, further human studies are required in order to demonstrate the absorption, and bioavailability of metabolites that may also be efficient in vivo.

The main objective of this clinical trial is to investigate the possible difference in the bioavailability of chlorogenic and phenolic acids from coffee at different roast levels.

After medical examination and approval, subjects will be randomly assigned to one of the four coffee treatments. Each study period correspond to the ingestion of one the treatments and study periods are separated by a one week washout period. Blood will be taken as a time course for 24h while urine will be collected for 30h. Investigators are also blinded with respect to the dose and the treatment given to the subjects.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Soluble coffee 1

Group Type EXPERIMENTAL

Coffee bioavailability trial

Intervention Type OTHER

Coffee bioavailability trial

Soluble coffee 2

Group Type EXPERIMENTAL

Coffee bioavailability trial

Intervention Type OTHER

Coffee bioavailability trial

Soluble coffee 3

Group Type EXPERIMENTAL

Coffee bioavailability trial

Intervention Type OTHER

Coffee bioavailability trial

Soluble coffee 4

Group Type EXPERIMENTAL

Coffee bioavailability trial

Intervention Type OTHER

Coffee bioavailability trial

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Coffee bioavailability trial

Coffee bioavailability trial

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 20 - 60 years, male and female
* healthy as determined by the medical questionnaire and the medical visit
* normal weight: BMI 19 - 25
* Coffee drinkers with an average consumption of 2-5 cups per day
* having given informed consent

Exclusion Criteria

* Intestinal or metabolic diseases / disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer
* food allergy
* Have had a major gastrointestinal surgery
* 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 \> 5 cigarettes a day
* Have given blood within the last 3 weeks before the start of the study
* 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

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maurice Beaumont, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Société des Produits Nestlé (SPN)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

NESTEC/Clinical Development Unit / Metabolic Unit

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10.04.Met

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Coffee and In-vivo Oxidative Stress
NCT00868205 COMPLETED PHASE2
Interindividual Variation in Response to Green Coffee
NCT06204445 ACTIVE_NOT_RECRUITING NA
Immune Benefits of Coffee
NCT00860197 COMPLETED NA
Whole Coffee Cherry Study
NCT04986956 COMPLETED NA