Clinical trial NCT02520596: Absorption and Metabolism of Dietary Phenolics From Raspberries
Official title: Bioavailability of Anthocyanins in Humans Following the Ingestion of Berries and Grapes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modifications
Keywords: Raspberries
Anthocyanins
Ellagitannins
Metabolites
Lead sponsor: University of Parma
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: National Processed Raspberry Council
First posted: 2015-08-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Red raspberries are a rich source of (poly)phenolic compounds, the main components being anthocyanins and ellagitannins. There is growing evidence linking consumption of these compounds with beneficial effects on human health. However, the mechanisms involved remain poorly understood principally because of a limited understanding of the bioavailability of ellagitannins and anthocyanins. This study aims to explore the identity and amounts of the phenolic metabolites of anthocyanins and ellagitannins in human plasma and urine following acute ingestion of raspberries. For this purpose ten healthy volunteers were feed 300 g of blended raspberries containing in total 293 μmol anthocyanins and 250 μmol ellagitannins. All urine excreted over 48 h after the ingestion of raspberries was collected and blood samples were collected before (0 h) and after raspberry consumption up to 24 h. Metabolites were identified and quantified by ultra high performance liquid chromatography-mass spectrometry (UHPLC-MS).


Eligibility criteria: Inclusion Criteria:

* in general good health

Exclusion Criteria:

* smoking
* pregnancy
* vegetarian
* sustained use of nutritional supplements

Primary outcomes:
measure: Changes in urinary anthocyanin and ellagitannin metabolite excretion after ingestion of 300g blended raspberries measured by ultra-high performance liquid chromatography-mass spectrometry
timeFrame: baseline excretion (12 h before intervention), and 0-4 h, 4-8 h, 8-24 h, 24-32 h, 32-48 h post ingestion
Secondary outcomes:
measure: Changes in plasma concentration of anthocyanin and ellagitannin metabolites after ingestion of 300g blended raspberries measured by ultra-high performance liquid chromatography-mass spectrometry
timeFrame: 0 h, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 24 h post ingestion
Other outcomes:
Locations:
city: Parma
country: Italy
facility: University of Parma - Department of Food Science
Study officials:
affiliation: University of Parma
name: Daniele Del Rio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gonzalez-Barrio R, Borges G, Mullen W, Crozier A. Bioavailability of anthocyanins and ellagitannins following consumption of raspberries by healthy humans and subjects with an ileostomy. J Agric Food Chem. 2010 Apr 14;58(7):3933-9. doi: 10.1021/jf100315d.
citation: Gonzalez-Barrio R, Edwards CA, Crozier A. Colonic catabolism of ellagitannins, ellagic acid, and raspberry anthocyanins: in vivo and in vitro studies. Drug Metab Dispos. 2011 Sep;39(9):1680-8. doi: 10.1124/dmd.111.039651. Epub 2011 May 27.
citation: Stalmach A, Edwards CA, Wightman JD, Crozier A. Gastrointestinal stability and bioavailability of (poly)phenolic compounds following ingestion of Concord grape juice by humans. Mol Nutr Food Res. 2012 Mar;56(3):497-509. doi: 10.1002/mnfr.201100566. Epub 2012 Feb 14.
citation: Fang J. Some anthocyanins could be efficiently absorbed across the gastrointestinal mucosa: extensive presystemic metabolism reduces apparent bioavailability. J Agric Food Chem. 2014 May 7;62(18):3904-11. doi: 10.1021/jf405356b. Epub 2014 Mar 31.
citation: de Ferrars RM, Czank C, Zhang Q, Botting NP, Kroon PA, Cassidy A, Kay CD. The pharmacokinetics of anthocyanins and their metabolites in humans. Br J Pharmacol. 2014 Jul;171(13):3268-82. doi: 10.1111/bph.12676.
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: Cassidy A, Mukamal KJ, Liu L, Franz M, Eliassen AH, Rimm EB. High anthocyanin intake is associated with a reduced risk of myocardial infarction in young and middle-aged women. Circulation. 2013 Jan 15;127(2):188-96. doi: 10.1161/CIRCULATIONAHA.112.122408.
citation: Del Rio D, Rodriguez-Mateos A, Spencer JP, Tognolini M, Borges G, Crozier A. Dietary (poly)phenolics in human health: structures, bioavailability, and evidence of protective effects against chronic diseases. Antioxid Redox Signal. 2013 May 10;18(14):1818-92. doi: 10.1089/ars.2012.4581. Epub 2012 Aug 27.
citation: Stalmach A, Edwards CA, Wightman JD, Crozier A. Identification of (poly)phenolic compounds in concord grape juice and their metabolites in human plasma and urine after juice consumption. J Agric Food Chem. 2011 Sep 14;59(17):9512-22. doi: 10.1021/jf2015039. Epub 2011 Aug 12.