ClinicalTrials.gg
CompletedNCT03248115POBASUpdated Aug 21, 2017

Bioavailability of Green Tea and Coffee Polyphenols

An interventional study of Green tea and green coffee extract tablets in Diet, Food, and Nutrition and Dietary Supplements, sponsored by MRC Human Nutrition Research. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-21.

Sponsored by MRC Human Nutrition Research · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 4 years 3 months after the study started (first participant enrolled Apr 2013, registered Aug 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Diet, Food, and Nutrition
  • Dietary Supplements

Keywords

  • polyphenols
  • green tea catechins
  • coffee caffeoylquinic acids
  • metabolism
  • inter-individual variability
  • colonic microbiota
03

In context

Lead sponsor

This is the only study on the registry with MRC Human Nutrition Research as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy men and women.
  • 18-45 years of age.
  • BMI between 18.5 and 24.9 kg/m2.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Interventions

  • Dietary supplementGreen tea and green coffee extract tablets

    1. Tablets: participants were required to take 6 green tea and 3 green coffee extract tablets daily for a period of 8 weeks. No tablets were taken during the last 4 weeks of the study. Randomly chosen tablets were analysed to quantify their polyphenol content. 2. Urine collections: Several urine collections were required during the supplementation period in order have sufficient time points to estimate the plateau of the concentration of green tea and coffee polyphenols excreted in the urine to then be able to determine their bioavailability. There was a total of five 24-hour urine collections (at week 0 -before supplementation-, 2, 4, 8, and 12 -4 weeks after finishing the supplementation period). 3. Completion of study documents: Participants were provided with urine collection sheets, polyphenol questionnaires, checklists to record polyphenol tablet intake, and detailed instructions.

06

What researchers measure

Primary outcomes

  1. Change from baseline phenolic metabolites in urine at 2 weeks

    Assessment of the profile of metabolites coming from green tea and green coffee phytochemicals in urine

    Time frame: Week 0 -before supplementation- and week 2

  2. Change from baseline phenolic metabolites in urine at 4 weeks

    Assessment of the profile of metabolites coming from green tea and green coffee

    Time frame: Week 0 -before supplementation- and week 4

  3. Change from baseline phenolic metabolites in urine at 8 weeks

    Assessment of the profile of metabolites coming from green tea and green coffee

    Time frame: Week 0 -before supplementation- and week 8

  4. Change from baseline phenolic metabolites in urine at 12 weeks

    Assessment of the profile of metabolites coming from green tea and green coffee

    Time frame: Week 0 -before supplementation- and week 12 -4 weeks after finishing the supplementation period-

Secondary outcomes

  1. Phenolic compounds in tablets

    Quantification of the tablet polyphenol content

    Time frame: Through study completion, an average of 3 months

07

Study locations

1 site
  • MRC HNR Elsie Widdowson Laboratory
    Cambridge, CB1 9NL, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2013 to primary completion in Oct 2013, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2017
First posted
Aug 14, 2017
StartActual
Apr 10, 2013
Primary completionActual
Oct 18, 2013
CompletionActual
Oct 18, 2013
Last update
Aug 21, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03248115
Lead sponsor
MRC Human Nutrition Research
Responsible party
Virginia Tomatis (Principal Investigator, MRC Human Nutrition Research) — Principal investigator
First posted
Aug 14, 2017
Start date
Apr 10, 2013
Primary completion
Oct 18, 2013
Completion
Oct 18, 2013
Last update
Aug 21, 2017

Study contacts

Virginia Tomatis, PhD
principal investigator · MRC HNR

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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