NCT03577145

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

1.4 years

First QC Date

December 19, 2017

Last Update Submit

January 17, 2019

Conditions

Keywords

BioavailabilityPolyphenolsDietary fibrePhenolic acids

Outcome Measures

Primary Outcomes (1)

  • Phenolic acids bioavailability

    Urine excretion of phenolic acids (µg) will be measured with GC-MS

    0-24 hrs

Secondary Outcomes (4)

  • Glycaemic measurements

    0-8 hrs

  • Appetite hormones measurements

    0-8 hrs

  • Mouth to caecum transit time

    0-8 hrs

  • Gastric emptying time

    0-6 hrs

Study Arms (3)

Tomato, onion & lovage soup with inulin

EXPERIMENTAL

One dose of tomato (300g), onion (100g) \& lovage (20g) with 10g inulin will be given to subjects in the form of a soup

Dietary Supplement: Tomato, onion & lovage soup with inulin

Tomato, onion & lovage soup

EXPERIMENTAL

One dose of tomato (300g), onion (100g) \& lovage (20g) will be given to subjects in the form of a soup

Dietary Supplement: Tomato, onion & lovage soup

Inulin

EXPERIMENTAL

One dose of 10g inulin will be given to subjects in the form of a drink

Dietary Supplement: Inulin

Interventions

Source of polyphenols and non digestible carbohydrate

Tomato, onion & lovage soup with inulin
Tomato, onion & lovage soupDIETARY_SUPPLEMENT

Source of polyphenols

Tomato, onion & lovage soup
InulinDIETARY_SUPPLEMENT

Source of non digestible carbohydrate

Inulin

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-reported healthy adults

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine, Nursing and Dentistry, College of MVLS, University of Glasgow

Glasgow, Lanarkshire, G31 2ER, United Kingdom

Location

Related Publications (3)

  • Russell W, Duthie G. Plant secondary metabolites and gut health: the case for phenolic acids. Proc Nutr Soc. 2011 Aug;70(3):389-96. doi: 10.1017/S0029665111000152.

    PMID: 21781364BACKGROUND
  • Roowi S, Mullen W, Edwards CA, Crozier A. Yoghurt impacts on the excretion of phenolic acids derived from colonic breakdown of orange juice flavanones in humans. Mol Nutr Food Res. 2009 May;53 Suppl 1:S68-75. doi: 10.1002/mnfr.200800287.

    PMID: 19415668BACKGROUND
  • Tamura M, Nakagawa H, Tsushida T, Hirayama K, Itoh K. Effect of pectin enhancement on plasma quercetin and fecal flora in rutin-supplemented mice. J Food Sci. 2007 Nov;72(9):S648-51. doi: 10.1111/j.1750-3841.2007.00557.x.

    PMID: 18034749BACKGROUND

MeSH Terms

Interventions

Inulin

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Christine Edwards, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Acute human bioavailability studies with a cross-over design. Subjects will be given a soup or drink in one of three combinations 1. Tomato onion and lovage soup 2. Inulin 3. Mixture of tomato onion and lovage soup with inulin
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 19, 2017

First Posted

July 5, 2018

Study Start

July 27, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 18, 2019

Record last verified: 2019-01

Locations