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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Tomato, onion and lovage soup (TOL); Other: TOL soup with inulin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Glasgow, Scotland, United Kingdom, G31 2ER
      • University of Glasgow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Habitual diet; participants remain on their habitual diet
Experimental: Tomato, onion and lovage soup (TOL); One tin of soup containing Tomato onion and lovage daily for 6 weeks	Other: Tomato, onion and lovage soup (TOL); Soup
Experimental: TOL soup with inulin; One tin of Tomato, onion and lovage soup with added inulin for 6 weeks	Other: TOL soup with inulin; Soup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of total amount of phenolic acids (umoles/24 hours) in urine (3 wk)	Profile and amounts of phenolic acids in urine derived from the colonic bacterial metabolism of polyphenols	3 weeks
Change from baseline of total amount of phenolic acids (umoles/24 hours) in urine (6 wk)	Profile and amounts of phenolic acids in urine derived from the colonic bacterial metabolism of polyphenols	6 weeks

Collaborators and Investigators

• Sponsor: University of Glasgow
• Collaborators: Scottish Universities Environmental Research Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2018
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: self-reported healthy adults; age 40-70; BMI > 25
• Other Study ID Numbers: BB/M027724/1-3

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