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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03383809
Other study ID # BB/MO27724/1-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 28, 2017
Est. completion date July 6, 2019

Study information

Verified date July 2019
Source University of Glasgow
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date July 6, 2019
Est. primary completion date July 6, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility 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, 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Strawberry juice with Inulin
Mixture of polyphenols and non digestible carbohydrates
Strawberry Juice
Source of Polyphenols
Inulin
Source of non digestible carbohydrate

Locations

Country Name City State
United Kingdom School of Medicine, Nursing and Dentistry, College of MVLS, University of Glasgow Glasgow Lanarkshire

Sponsors (2)

Lead Sponsor Collaborator
University of Glasgow Scottish Universities Environmental Research Centre

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Phenolic acids bioavailability Urine excretion of phenolic acids 0-24 hrs
Secondary Urolithin bioavailability Urine excretion of urolithins 0-24 hrs
Secondary Glycaemic and appetite hormones measurements by ELISA Plasma glucose, insulin and appetite hormone levels 0-8 hrs
Secondary Mouth to caecum transit time Breath hydrogen level measurements by Hydrogen monitor 0-8 hrs
Secondary Gastric emptying time Plasma paracetamol levels by acetaminophen assay kits 0-6 hrs
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