Impact of Inulin on Production of Phenolic Acids From Tomato Onion and Lovage Soup

January 17, 2019 updated by: Christine Edwards, University of Glasgow

This is an acute human bioavailability study in self-reported healthy participants aged 20-70 years old. The investigators hypothesize that combination of polyphenolics from a soup rich in rutin and quercitin and the non-digestible carbohydrate (NDC) inulin will increase the production of phenolic acids by bacteria in the human colon and these will be detected in urine. Participants will attend for three arms in a randomized order: Tomato, onion and lovage soup (high polyphenol food), Inulin (NDC) or Mixture of tomato, onion and lovage soup and inulin.

During each feeding study, urine, blood and stool samples will be collected at regular intervals for the duration of 24 hrs after consumption of test food. Participants will be asked to follow a low polyphenol diet for 2 days prior to the feeding study.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G31 2ER
        • School of Medicine, Nursing and Dentistry, College of MVLS, University of Glasgow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Self-reported healthy adults

Exclusion Criteria:

  • Antibiotic use within the last 3 months
  • Identified gastro-intestinal diseases
  • On prescribed medication other than the contraceptive pill
  • Pregnant or breastfeeding.
  • Diagnosed as anaemic
  • Allergic to paracetamol or any food

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tomato, onion & lovage soup with inulin
One dose of tomato (300g), onion (100g) & lovage (20g) with 10g inulin will be given to subjects in the form of a soup
Source of polyphenols and non digestible carbohydrate
EXPERIMENTAL: Tomato, onion & lovage soup
One dose of tomato (300g), onion (100g) & lovage (20g) will be given to subjects in the form of a soup
Source of polyphenols
EXPERIMENTAL: Inulin
One dose of 10g inulin will be given to subjects in the form of a drink
Source of non digestible carbohydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phenolic acids bioavailability
Time Frame: 0-24 hrs
Urine excretion of phenolic acids (µg) will be measured with GC-MS
0-24 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycaemic measurements
Time Frame: 0-8 hrs
Plasma glucose (mmol/L), insulin (mU/L) will be measured by commercial kits
0-8 hrs
Appetite hormones measurements
Time Frame: 0-8 hrs
Appetite hormone (PYY) levels in plasma (pg/mL) will be measured by commercial Elisa kit
0-8 hrs
Mouth to caecum transit time
Time Frame: 0-8 hrs
Mouth to caecum transit time (in hours/mins) will be calculated from sustained rise in breath hydrogen level measurements by hydrogen monitor
0-8 hrs
Gastric emptying time
Time Frame: 0-6 hrs
Gastric emptying time (in hours/mins) will be estimated using kinetics of plasma paracetamol levels measured by acetaminophen assay kits
0-6 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christine Edwards, PhD, University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 27, 2017

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

July 2, 2018

First Posted (ACTUAL)

July 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • BB/MO27724/1-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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