Bioavailability of Chlorogenic and Phenolic Acids From Soluble Coffees
1 other identifier
interventional
14
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Nov 2010
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 21, 2011
CompletedFirst Posted
Study publicly available on registry
July 22, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedMay 22, 2014
May 1, 2014
7 months
July 21, 2011
May 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Composite of pharmacokinetics: sum of AUC of chlorogenic and phenolic acids the of extreme treatments.
18 months
Secondary Outcomes (1)
Composite of pharmacokinetics: AUC, Sum of AUC, Cmax, Tmax and T1/2 of plasma chlorogenic and phenolic acids from the other treatments.
18 months
Study Arms (4)
Soluble coffee 1
EXPERIMENTALSoluble coffee 2
EXPERIMENTALSoluble coffee 3
EXPERIMENTALSoluble coffee 4
EXPERIMENTALInterventions
Coffee bioavailability trial
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NESTEC/Clinical Development Unit / Metabolic Unit
Lausanne, Canton of Vaud, 1000, Switzerland
Study Officials
- PRINCIPAL INVESTIGATOR
Maurice Beaumont, MD, Ph.D
Société des Produits Nestlé (SPN)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2011
First Posted
July 22, 2011
Study Start
November 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2013
Last Updated
May 22, 2014
Record last verified: 2014-05