Condition category
Urological and Genital Diseases
Date applied
02/09/2019
Date assigned
05/09/2019
Last edited
06/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cranberries (Vaccinium macrocarpon) are a rich source of bioactive compounds, in particular proanthocyanidins (PAC), with potential impact on human health. Several studies suggest that PACs (type A) help to prevent or reduce up to 40%–50% urinary tract infections (UTIs), especially for women who have a history of recurrent infections. The hypothesized mechanism of action seems related to the capacity of PACs to reduce the adhesion of the bacteria E. coli (the most common pathogen causing UTIs) to cells lining the urinary tract and bladder.
The aim of the present project is to identify the components of cranberry (PAC and metabolites) present at urinary level and potentially responsible for UTI activity. The second part of the project will plan to identify, among the components/metabolites present at urinary level, those that may exert antimicrobial action on the microorganisms responsible for the UTIs, including Candida Albicans and E. Coli, in order to elucidate the mechanism of action.

Who can participate?
Women aged 18 - 40 years.

What does the study involve?
Participants will be randomised to take either one of two different cranberry based supplements or placebo twice a day for seven days. Urine samples will be taken for two days following the last capsule. After 30 days the participants will take a different capsule for seven days, and after another 30 days another different capsule for 30 days.

What are the possible benefits and risks of participating?
Cranberry polyphenols may be metabolised and exert a protection against urinary tract infections. There are no notable risks involved with participating.

Where is the study run from?
1. Department of Pharmaceutical Sciences, DiSFARM- Università degli Studi di Milano, Italy
2. Department of Food, Environmental and Nutritional Sciences, DeFENS-Università degli Studi di Milano, Italy
3. Department of Health Sciences, Università degli Studi di Milano, Italy

When is the study starting and how long is it expected to run for?
February to March 2019

Who is funding the study?
Indena SpA, Italy

Who is the main contact?
1. Prof. Giancarlo Aldini
giancarlo.aldini@unimi.it
2. Dr Cristian Del Bo'
cristian.delbo@unimi.it

Trial website

Contact information

Type

Scientific

Primary contact

Prof Giancarlo Aldini

ORCID ID

http://orcid.org/0000-0002-2355-6744

Contact details

Via Mangiagalli
25
Milano
20133
Italy
+390250319296
giancarlo.aldini@unimi.it

Type

Scientific

Additional contact

Dr Cristian Del Bo'

ORCID ID

http://orcid.org/0000-0001-7562-377X

Contact details

Via Celoria 2
milano
20133
Italy
+390250316730
cristian.delbo@unimi.it

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Profiling Vaccinium macrocarpon components and metabolites in human urine and the urine ex-vivo effect on Candida albicans adhesion and biofilm-formation

Acronym

CRAME

Study hypothesis

The present pilot study aims to test the hypothesis that some bioactive compounds from standardized cranberry extracts are absorbed, metabolized and excreted in urine and can exert protection against urinary tract infections

Ethics approval

Approved 18/12/2018, Ethics Committee of the University of Milan (Università degli Studi di Milano,
Via Festa del Perdono 7, 20122, Milano, Italy; +39 2 503 12667; comitato.etico@unimi.it), ref: 57/18

Study design

A controlled randomized intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Urinary tract infection

Intervention

Ten healthy women will be enrolled and randomized for the intervention. Subjects will be randomized, based on a computer randomization plan. Two different food supplements, based on standardized cranberry extracts, and a placebo will be tested:
1. Cranberry capsules (Anthocran, Vaccinium macrocarpon Aiton.)
2. Cranberry capsules (Antocran Phytosome, Vaccinium macrocarpon Aiton. containing sunflower lecithin)
3. Placebo capsules (containing microcrystalline cellulose, silicon dioxide, magnesium stearate)

Each subject will consume two capsules per day (one in the morning and on in the evening) of cranberry extracts or placebo. Each treatment will be 7-day long and separated by at least 30-day wash-out period. At the beginning (before capsule intake) and at the end of the intervention (7 days), urine will be collected at time 1, 2, 4, 6, 10,12, 14, 24, 48 hours from the intake of the last capsule.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Detection at time 1, 2, 4, 6, 10,12, 14, 24, 48 hours (from the intake of the last capsule) of cranberry bioactive constituents in urine (type A proanthocyanidin) and metabolites including hydroxybenzoic acids and valerolactones evaluated by high-resolution mass spectrometry.

Secondary outcome measures

1. Detection of other potential cranberry polyphenol metabolites in urines evaluated by high-resolution mass spectrometry
2. Ex-vivo inhibition of Candida albicans adhesion and biofilm formation by using the urine collected from the subjects at different time points

Overall trial start date

10/04/2018

Overall trial end date

31/05/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women
2. Age 18-40 years
3. BMI 18-25 kg/m2
4. Healthy

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

10

Participant exclusion criteria

1. Smokers
2. Allergy to cranberry
3. Gastrointestinal disorder
4. Liver and renal disease
5. Antibiotic treatment

Recruitment start date

15/01/2019

Recruitment end date

15/02/2019

Locations

Countries of recruitment

Italy

Trial participating centre

Department of Pharmaceutical Sciences, DiSFARM- Università degli Studi di Milano
Via L. Mangiagalli, 25
MILANO
20133
Italy

Trial participating centre

Department of Food, Environmental and Nutritional Sciences, DeFENS-Università degli Studi di Milano
Via L. Mangiagalli, 25
MILANO
20133
Italy

Trial participating centre

Department of Health Sciences, Università degli Studi di Milano
Via Di Rudinì 8
MILANO
20146
Italy

Sponsor information

Organisation

Indena Spa

Sponsor details

Viale Ortles 12
Milano
20139
Italy
+3902574961
antonella.riva@indena.com

Sponsor type

Industry

Website

http://www.indena.com/company-profile/

Funders

Funder type

Industry

Funder name

Indena SpA

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/12/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/09/2019: Internal review. 04/09/2019: Trial’s existence confirmed by Universita Degli Studi di Milano