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Completed

NCT Number: NCT03248115

Bioavailability of Green Tea and Coffee Polyphenols

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MRC HNR Elsie Widdowson Laboratory

Cambridge, CB1 9NL, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Green tea and green coffee extract tablets

Dietary Supplement
  • 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.
  • 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).
  • Completion of study documents: Participants were provided with urine collection sheets, polyphenol questionnaires, checklists to record polyphenol tablet intake, and detailed instructions.

Primary outcomes

  1. 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

  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

  3. 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

  4. 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

Secondary outcomes

  1. Phenolic compounds in tablets

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

    Quantification of the tablet polyphenol content

Sponsors and collaborators

Lead sponsor

MRC Human Nutrition Research

Other Gov

Registry information

Official study title

Bioavailability of Green Tea and Coffee Polyphenols in Healthy Participants

Acronym: POBAS

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 14, 2017
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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