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

NCT ID: NCT03840746

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-11
• Study Completion Date: 2019-09-30

Brief Summary

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Habitual diet

participants remain on their habitual diet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Tomato, onion and lovage soup (TOL)

One tin of soup containing Tomato onion and lovage daily for 6 weeks

Group Type: EXPERIMENTAL

Tomato, onion and lovage soup (TOL)

Intervention Type: OTHER

Soup

TOL soup with inulin

One tin of Tomato, onion and lovage soup with added inulin for 6 weeks

Group Type: EXPERIMENTAL

TOL soup with inulin

Intervention Type: OTHER

Soup

Interventions

Tomato, onion and lovage soup (TOL)

Soup

Intervention Type: OTHER

TOL soup with inulin

Soup

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Scottish Universities Environmental Research Centre

OTHER

Sponsor Role: collaborator

University of Glasgow

OTHER

Sponsor Role: lead

Responsible Party

Christine Edwards

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Glasgow

Glasgow, Scotland, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BB/M027724/1-3

Identifier Type: -

Identifier Source: org_study_id