Skip to main content
OpenTrials
Completed

NCT Number: NCT03840746

Interactions Between Fibre and Polyphenols on Colonic Phenolic Acid Production and Biomarkers of Health ( 6 Weeks)

The investigators have studied the acute interactions of polyphenols and NDC in a single meal in a human study containing tomatoes, lovage & onions, with and without inulin. The investigators now wish to study the longer-term interactions of these foods over 6 weeks as well as their impact on biomarkers of human health, the gut microbiome, human proteome and markers of risk of chronic disease. This may allow better targeted evaluation of foods which influence health through the gut microbiome.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Glasgow

Glasgow, Scotland, G31 2ER, United Kingdom

About this study

Polyphenol rich plant foods have been associated with several health benefits but their bioavailability is generally low. The majority of plant polyphenols are poorly absorbed in the small intestine and enter the colon where the colonic microbiota metabolise them to release a range of phenolic acids, which are now thought to be the main bioactive components related to the reduction in disease risk. Very little is known about the impact of other constituents of the diet on the metabolism and bacterial catabolism of these polyphenols.

Colonic bacteria are key agents in the release of the bioactive molecules from polyphenols but also ferment non-digestible carbohydrates (NDC) such as inulin to short chain fatty acids. It is likely that there are key interactions in the colonic bacterial metabolism of NDC and phenolics. The investigators hypothesize that combination of polyphenolics (in onions, tomatoes and lovage) with inulin (NDC) will increase the urinary output of bioactive phenolic acids over a 6 week feeding trial and impact on biomarkers of cardiometabolic health.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Generally healthy
  • BMI>=25
  • Not on antibiotics within 3 months of starting of study
  • No medication likely to influence gut function, colonic bacterial activity.

Exclusion criteria

  • Antibiotics
  • Pregnancy
  • lactation

Treatment and study plan

Tomato, onion and lovage soup (TOL)

Other

Soup

TOL soup with inulin

Other

Soup

Primary outcomes

  1. Change from baseline of total amount of phenolic acids (umoles/24 hours) in urine (3 wk)

    Time frame: 3 weeks

    Profile and amounts of phenolic acids in urine derived from the colonic bacterial metabolism of polyphenols

  2. Change from baseline of total amount of phenolic acids (umoles/24 hours) in urine (6 wk)

    Time frame: 6 weeks

    Profile and amounts of phenolic acids in urine derived from the colonic bacterial metabolism of polyphenols

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Collaborators

  • Scottish Universities Environmental Research Centre

Registry information

Official study title

6 Week Feeding Study of Interactions Between Fibre and Polyphenols Sources on Colonic Phenolic Acid Production and Biomarkers of Health

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2019
Registry last updated
Mar 27, 2023

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.

Published trials that share one or more normalized conditions with this study.