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

NCT03840746 | Completed DMC

• 1 other identifier: BB/M027724/1-3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

self-reported healthy adults; age 40-70; BMI > 25

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Habitual diet

NO INTERVENTION

participants remain on their habitual diet

Tomato, onion and lovage soup (TOL)

EXPERIMENTAL

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

Other: Tomato, onion and lovage soup (TOL)

TOL soup with inulin

EXPERIMENTAL

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

Other: TOL soup with inulin

Interventions

Tomato, onion and lovage soup (TOL) OTHER

Soup

Tomato, onion and lovage soup (TOL)

TOL soup with inulin OTHER

Soup

TOL soup with inulin

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Antibiotics
• Pregnancy
• lactation

Sponsors & Collaborators

• University of Glasgow: lead
• Scottish Universities Environmental Research Centre: collaborator

Study Sites (1)

University of Glasgow

Glasgow, Scotland, G31 2ER, United Kingdom

Location

MeSH Terms

Interventions

Inulin

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: soups in plain tins and labelled A or B. Code held by person not part of study team.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This intervention study will be carried out using a parallel design, with three arms (foods containing polyphenol+NDC, foods with polyphenol alone, and habitual diet control)

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: February 15, 2019
• Study Start: July 11, 2018
• Primary Completion: July 30, 2019
• Study Completion: September 30, 2019
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)