- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03383809
Impact of Non Digestible Carbohydrate on Production of Phenolic Acids From Strawberry Juice
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lanarkshire
-
Glasgow, Lanarkshire, United Kingdom, G31 2ER
- School of Medicine, Nursing and Dentistry, College of MVLS, University of Glasgow
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
Mixture of polyphenols and non digestible carbohydrates
|
Experimental: Strawberry juice
One dose of 300 g of strawberry juice will be given to subjects in the form of juice
|
Source of Polyphenols
|
Experimental: Inulin
One dose of 10 g of inulin will be given to subjects in the form of a drink
|
Source of non digestible carbohydrate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phenolic acids bioavailability
Time Frame: 0-24 hrs
|
Urine excretion of phenolic acids
|
0-24 hrs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urolithin bioavailability
Time Frame: 0-24 hrs
|
Urine excretion of urolithins
|
0-24 hrs
|
Glycaemic and appetite hormones measurements by ELISA
Time Frame: 0-8 hrs
|
Plasma glucose, insulin and appetite hormone levels
|
0-8 hrs
|
Mouth to caecum transit time
Time Frame: 0-8 hrs
|
Breath hydrogen level measurements by Hydrogen monitor
|
0-8 hrs
|
Gastric emptying time
Time Frame: 0-6 hrs
|
Plasma paracetamol levels by acetaminophen assay kits
|
0-6 hrs
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Prof. Edwards, University of Glasgow
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BB/MO27724/1-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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