Impact of Non Digestible Carbohydrate on Production of Phenolic Acids From Strawberry Juice
1 other identifier
interventional
15
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Apr 2017
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2017
CompletedFirst Submitted
Initial submission to the registry
December 19, 2017
CompletedFirst Posted
Study publicly available on registry
December 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2019
CompletedJuly 12, 2019
July 1, 2019
2.2 years
December 19, 2017
July 11, 2019
Conditions
Keywords
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
EXPERIMENTALOne dose of 300 g of strawberry with 10 g of inulin will be given to subjects in the form of juice
Strawberry juice
EXPERIMENTALOne dose of 300 g of strawberry juice will be given to subjects in the form of juice
Inulin
EXPERIMENTALOne dose of 10 g of inulin will be given to subjects in the form of a drink
Interventions
Mixture of polyphenols and non digestible carbohydrates
Eligibility Criteria
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
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: 21781364BACKGROUNDRoowi 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: 19415668BACKGROUNDHenning 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: 23319439BACKGROUNDCzank 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: 23604435BACKGROUNDMorrison 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
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prof. Edwards
University of Glasgow
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- 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