Bioavailability of Green Tea and Coffee Polyphenols (POBAS)

August 16, 2017 updated by: Virginia Tomatis, MRC Human Nutrition Research

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

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cambridge, United Kingdom, CB1 9NL
        • MRC HNR Elsie Widdowson Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Virginia Tomatis, PhD, MRC HNR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 10, 2013

Primary Completion (ACTUAL)

October 18, 2013

Study Completion (ACTUAL)

October 18, 2013

Study Registration Dates

First Submitted

August 7, 2017

First Submitted That Met QC Criteria

August 9, 2017

First Posted (ACTUAL)

August 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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