- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01400386
Bioavailability of Chlorogenic and Phenolic Acids From Soluble Coffees
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.
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vaud
-
Lausanne 26, Vaud, Switzerland, 1000
- NESTEC/Clinical Development Unit / Metabolic Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Soluble coffee 1
|
Coffee bioavailability trial
|
Experimental: Soluble coffee 2
|
Coffee bioavailability trial
|
Experimental: Soluble coffee 3
|
Coffee bioavailability trial
|
Experimental: Soluble coffee 4
|
Coffee bioavailability trial
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Composite of pharmacokinetics: sum of AUC of chlorogenic and phenolic acids the of extreme treatments.
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Composite of pharmacokinetics: AUC, Sum of AUC, Cmax, Tmax and T1/2 of plasma chlorogenic and phenolic acids from the other treatments.
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maurice Beaumont, MD, Ph.D, Nestlé
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 10.04.Met
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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