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CompletedNCT03383809Updated Jul 12, 2019

Impact of Non Digestible Carbohydrate on Production of Phenolic Acids From Strawberry Juice

An interventional study of Strawberry juice with Inulin and Strawberry Juice in Healthy, sponsored by University of Glasgow. Completed at 1 site in United Kingdom. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-12.

Sponsored by University of Glasgow · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

Read the 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. The colonic microbiota are key agents in the release of the bioactive molecules from polyphenols but also ferment non-digestible carbohydrates (NDC) such as dietary fibre to short chain fatty acids. It is likely that there are key interactions in the colonic bacteria metabolism of fibre and phenolics. We hypothesize that combination of polyphenolics and non-digestible carbohydrates (NDC) will increase the urinary output of bioactive phenolic acids.

This study will enable a better understanding of how to deliver combinations of ingredients and nutrients to achieve maximum nutritional value and health benefits.

02

Conditions studied

  • Healthy

Keywords

  • Self-reported healthy adults
03

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Self-reported healthy adults

Exclusion criteria

Exclusion Criteria:

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.

04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Strawberry juice with inulin

    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

  • Experimental
    Strawberry juice

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

    Dietary Supplement: Strawberry Juice

  • Experimental
    Inulin

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

    Dietary Supplement: Inulin

Interventions

  • Dietary supplementStrawberry juice with Inulin

    Mixture of polyphenols and non digestible carbohydrates

  • Dietary supplementStrawberry Juice

    Source of Polyphenols

  • Dietary supplementInulin

    Source of non digestible carbohydrate

05

What researchers measure

Primary outcomes

  1. Phenolic acids bioavailability

    Urine excretion of phenolic acids

    Time frame: 0-24 hrs

Secondary outcomes

  1. Urolithin bioavailability

    Urine excretion of urolithins

    Time frame: 0-24 hrs

  2. Glycaemic and appetite hormones measurements by ELISA

    Plasma glucose, insulin and appetite hormone levels

    Time frame: 0-8 hrs

  3. Mouth to caecum transit time

    Breath hydrogen level measurements by Hydrogen monitor

    Time frame: 0-8 hrs

  4. Gastric emptying time

    Plasma paracetamol levels by acetaminophen assay kits

    Time frame: 0-6 hrs

06

Study locations

1 site
  • School of Medicine, Nursing and Dentistry, College of MVLS, University of Glasgow
    Glasgow, Lanarkshire G31 2ER, United Kingdom
07

References and documents

Publications

  • 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. PubMed 21781364 ↗
  • 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. PubMed 19415668 ↗
  • 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. PubMed 23319439 ↗
  • 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. PubMed 23604435 ↗
  • 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. PubMed 21818809 ↗
08

Registry details

Key details

Study ID
NCT03383809
Lead sponsor
University of Glasgow
Collaborators
Scottish Universities Environmental Research Centre
Responsible party
Christine Edwards (Professor, University of Glasgow) — Principal investigator
First posted
Dec 26, 2017
Start date
Apr 28, 2017
Primary completion
Jul 6, 2019
Completion
Jul 6, 2019
Last update
Jul 12, 2019

Study contacts

Prof. Edwards
principal investigator · University of Glasgow

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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