- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02520596
Absorption and Metabolism of Dietary Phenolics From Raspberries
August 7, 2015 updated by: Daniele Del Rio, University of Parma
Bioavailability of Anthocyanins in Humans Following the Ingestion of Berries and Grapes
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Parma, Italy, 43125
- University of Parma - Department of Food Science
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- in general good health
Exclusion Criteria:
- smoking
- pregnancy
- vegetarian
- sustained use of nutritional supplements
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in urinary anthocyanin and ellagitannin metabolite excretion after ingestion of 300g blended raspberries measured by ultra-high performance liquid chromatography-mass spectrometry
Time Frame: baseline excretion (12 h before intervention), and 0-4 h, 4-8 h, 8-24 h, 24-32 h, 32-48 h post ingestion
|
All urine excreted for 12 h prior to supplementation was collected as well as that excreted over 48 h after ingestion of raspberries.
Urine samples were vortexed, centrifuged at 16110 g for 10 min at 5°C, and passed through 0.45 μm filter discs prior to the analysis of 5 μL aliquots by UHPLC-MS.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in plasma concentration of anthocyanin and ellagitannin metabolites after ingestion of 300g blended raspberries measured by ultra-high performance liquid chromatography-mass spectrometry
Time Frame: 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
|
Blood samples were collected in heparin tubes before and after raspberry consumption up to 24 h.
Plasma samples were vortexed and 400 µL aliquots were mixed with 1 mL of 2% formic acid in acetonitrile.
The samples were then vortexed and ultrasonicated for 10 min.
After centrifugation at 16110 g for 10 min, supernatants were reduced to dryness in vacuo using a Speedvac concentrator and resuspended in 100 µL of methanol:water:formic acid (50:50:0.1,
v/v/v) which was centrifuged at 16100 g for 10 min and 5 μL aliquots of the supernatant analysed by UHPLC-MS.
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniele Del Rio, PhD, University of Parma
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
July 31, 2015
First Submitted That Met QC Criteria
August 7, 2015
First Posted (Estimate)
August 13, 2015
Study Record Updates
Last Update Posted (Estimate)
August 13, 2015
Last Update Submitted That Met QC Criteria
August 7, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DDR-002
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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