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Dietary ModificationsNCT02520596

Absorption and Metabolism of Dietary Phenolics From Raspberries

A study testing Bioavailability of Raspberry polyphenols in people with Dietary Modifications, run by University of Parma at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Dietary Modifications
What is being tested?
Bioavailability of Raspberry polyphenols
How many people
10 participants
Where
1 siteItaly
Study dates
Nov 2013to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • in general good health

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University of Parma - Department of Food Science

    Parma, 43125

Other trials in Italy

About this study

Official title: 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).

Being tested
Bioavailability of Raspberry polyphenols
Keywords
Raspberries, Anthocyanins, Ellagitannins, Metabolites

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bioavailability of Raspberry polyphenolsOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in urinary anthocyanin and ellagitannin metabolite excretion after ingestion of 300g blended raspberries measured by ultra-high performance liquid chromatography-mass spectrometry

    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.

    Measured: 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 (1)

  1. Changes in plasma concentration of anthocyanin and ellagitannin metabolites after ingestion of 300g blended raspberries measured by ultra-high performance liquid chromatography-mass spectrometry

    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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2015 (estimated)
  2. Study startNov 2013
  3. Primary completionMar 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02520596
Sponsor's protocol ID
DDR-002
Status last verified
Aug 2015
First submitted
31 Jul 2015
Last updated
13 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20218618

  • 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.

    PubMed 21622625

  • 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.

    PubMed 22331633

  • 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.

    PubMed 24650097

  • 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.

    PubMed 24602005

  • 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.

    PubMed 23604435

  • 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.

    PubMed 23319811

  • 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.

    PubMed 22794138

  • 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.

    PubMed 21812481

Questions about this trial

What is this clinical trial studying?

A study testing Bioavailability of Raspberry polyphenols in people with Dietary Modifications, run by University of Parma at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02520596, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.

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