NCT03383809

Brief Summary

This is an acute human bioavailability study in self-reported healthy participants aged 20-70 years old. We hypothesize that combination of dietary polyphenolics and non-digestible carbohydrates (NDC) 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 randomised order: Strawberry juice (a high polyphenol food), Inulin (NDC) or Mixture of strawberry juice and inulin.

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 healthy

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable healthy

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

April 28, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2019

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

2.2 years

First QC Date

December 19, 2017

Last Update Submit

July 11, 2019

Conditions

Keywords

Self-reported healthy adults

Outcome Measures

Primary Outcomes (1)

  • Phenolic acids bioavailability

    Urine excretion of phenolic acids

    0-24 hrs

Secondary Outcomes (4)

  • Urolithin bioavailability

    0-24 hrs

  • Glycaemic and appetite hormones measurements by ELISA

    0-8 hrs

  • Mouth to caecum transit time

    0-8 hrs

  • Gastric emptying time

    0-6 hrs

Study Arms (3)

Strawberry juice with inulin

EXPERIMENTAL

One dose of 300 g of strawberry with 10 g of inulin will be given to subjects in the form of juice

Dietary Supplement: Strawberry juice with Inulin

Strawberry juice

EXPERIMENTAL

One dose of 300 g of strawberry juice will be given to subjects in the form of juice

Dietary Supplement: Strawberry Juice

Inulin

EXPERIMENTAL

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

Dietary Supplement: Inulin

Interventions

Mixture of polyphenols and non digestible carbohydrates

Strawberry juice with inulin
Strawberry JuiceDIETARY_SUPPLEMENT

Source of Polyphenols

Strawberry juice
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, individuals who are pregnant or breastfeeding. Individuals who have been diagnosed as anaemic, as well as those who are allergic to any food, or paracetamol.

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 (5)

  • 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
  • Henning SM, Wang P, Abgaryan N, Vicinanza R, de Oliveira DM, Zhang Y, Lee RP, Carpenter CL, Aronson WJ, Heber D. Phenolic acid concentrations in plasma and urine from men consuming green or black tea and potential chemopreventive properties for colon cancer. Mol Nutr Food Res. 2013 Mar;57(3):483-93. doi: 10.1002/mnfr.201200646. Epub 2013 Jan 14.

    PMID: 23319439BACKGROUND
  • Czank C, Cassidy A, Zhang Q, Morrison DJ, Preston T, Kroon PA, Botting NP, Kay CD. Human metabolism and elimination of the anthocyanin, cyanidin-3-glucoside: a (13)C-tracer study. Am J Clin Nutr. 2013 May;97(5):995-1003. doi: 10.3945/ajcn.112.049247.

    PMID: 23604435BACKGROUND
  • Morrison DJ, O'Hara JP, King RF, Preston T. Quantitation of plasma 13C-galactose and 13C-glucose during exercise by liquid chromatography/isotope ratio mass spectrometry. Rapid Commun Mass Spectrom. 2011 Sep 15;25(17):2484-8. doi: 10.1002/rcm.5139.

    PMID: 21818809BACKGROUND

MeSH Terms

Interventions

Inulin

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Prof. Edwards

    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 will be given to subjects in the form of a drink in one of three combinations 1. Strawberry juice alone 2. Inulin alone 3. Mixture of strawberry juice and inulin
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 19, 2017

First Posted

December 26, 2017

Study Start

April 28, 2017

Primary Completion

July 6, 2019

Study Completion

July 6, 2019

Last Updated

July 12, 2019

Record last verified: 2019-07

Locations