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
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