- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03248115
Bioavailability of Green Tea and Coffee Polyphenols (POBAS)
Bioavailability of Green Tea and Coffee Polyphenols in Healthy Participants
There is little information on the dietary intake, absorption, metabolism and bioavailability (degree to which a substance becomes available to the target tissues upon administration) of polyphenols (natural substances present in a variety of foods) in human participants.
This study assessed the bioavailability in healthy participants of polyphenols from 2 supplements containing green tea and green coffee extracts.
Eleven participants were recruited and their habitual diet was assessed to estimate polyphenol intake. After completing a 24-hour urine collection, participants were given six green tea extract and three green coffee extract tablets, which they took daily for a period of 8 weeks. No tablets were taken during the last 4 weeks of the study. Further 24-hour urines were collected at 2, 4, 8 and 12 weeks.
Participants were required to attend HNR (medical laboratory) the day after each 24hour urine collection. At these visits, they were asked to bring along their urine collections, completed documents (urine collection sheet, checklist for tablet intake/side effects) and any remaining supplements, which were used to assess tablet compliance.
The investigators identified and quantified the amount of polyphenols in the supplement tablets as well as the amount of polyphenols and their metabolites in urine. The investigators then evaluated polyphenol bioavailability from the relationship between their dietary intake and urinary output.
Evidence from this research could inform future intervention studies by providing data on the bioavailability of green tea and coffee polyphenols, and on the individual differences related to phenolic intake.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cambridge, United Kingdom, CB1 9NL
- MRC HNR Elsie Widdowson Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy men and women.
- 18-45 years of age.
- BMI between 18.5 and 24.9 kg/m2.
Exclusion Criteria:
- Smoking.
- Allergy or intolerance to intervention supplements.
- Chronic, acute or active inflammatory conditions, haematological disorders, or any other systemic illness of renal, hepatic or gastrointestinal origin.
- Major surgical operations in the gastrointestinal tract or medical treatment for gastrointestinal problems.
- Active cancer or diagnosis of malignancy within the last five years.
- Pregnant, lactating, contemplating pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline phenolic metabolites in urine at 2 weeks
Time Frame: Week 0 -before supplementation- and week 2
|
Assessment of the profile of metabolites coming from green tea and green coffee phytochemicals in urine
|
Week 0 -before supplementation- and week 2
|
Change from baseline phenolic metabolites in urine at 4 weeks
Time Frame: Week 0 -before supplementation- and week 4
|
Assessment of the profile of metabolites coming from green tea and green coffee
|
Week 0 -before supplementation- and week 4
|
Change from baseline phenolic metabolites in urine at 8 weeks
Time Frame: Week 0 -before supplementation- and week 8
|
Assessment of the profile of metabolites coming from green tea and green coffee
|
Week 0 -before supplementation- and week 8
|
Change from baseline phenolic metabolites in urine at 12 weeks
Time Frame: Week 0 -before supplementation- and week 12 -4 weeks after finishing the supplementation period-
|
Assessment of the profile of metabolites coming from green tea and green coffee
|
Week 0 -before supplementation- and week 12 -4 weeks after finishing the supplementation period-
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phenolic compounds in tablets
Time Frame: Through study completion, an average of 3 months
|
Quantification of the tablet polyphenol content
|
Through study completion, an average of 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Virginia Tomatis, PhD, MRC HNR
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HNR6480
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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