Clinical trial NCT03383809: Impact of Non Digestible Carbohydrate on Production of Phenolic Acids From Strawberry Juice
Official title: Impact of Non Digestible Carbohydrate on Production of Phenolic Acids From Strawberry Juice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Self-reported healthy adults
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: Scottish Universities Environmental Research Centre
First posted: 2017-12-26
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Phenolic acids bioavailability
timeFrame: 0-24 hrs
Secondary outcomes:
measure: Urolithin bioavailability
timeFrame: 0-24 hrs
measure: Glycaemic and appetite hormones measurements by ELISA
timeFrame: 0-8 hrs
measure: Mouth to caecum transit time
timeFrame: 0-8 hrs
measure: Gastric emptying time
timeFrame: 0-6 hrs
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: School of Medicine, Nursing and Dentistry, College of MVLS, University of Glasgow
state: Lanarkshire
Study officials:
affiliation: University of Glasgow
name: Prof. Edwards
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.