Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618768
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Can Consumption of an Aronia-mixture Prevent Urinary Tract Infections in Female Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Preventive Effect of Aronia Mixture Against UTI - a Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal is to determine the feasibility of conducting a randomised clinical trial to measure the effectiveness of an aronia mixture in reducing recurrence of urinary tract infections UTIs and antibiotic use by women with a history of frequent UTIs In addition the study aim to collect data in order to establish power calculations required for a full-scale study
Detailed Description:
Aronia berries have been and are used as a food especially in Eastern Europe and the USA No negative health effects have been reported from consuming similar amounts of aronia berries as those given to participants in this pilot study On the contrary studies suggest that consuming aronia berries has several positive health effects 1 The present 6-months pilot study will examine the feasibility of the study recruitment process drop-outs program adherence treatment duration program accetability identify potential biomarkers of the aronia-mixture and provide information to establish power calculations in a full-scale randomized controlled trial
Outcomes in the pilot study is number of UTI episodes both treated and untreated corresponding to historical episodes last 12 months characterization of uropathogens from urine culture analyses as well as characterization of phenolic metabolites in urine as a result of the intervention Findings of catabolites based on certain polyphenols will reflect the intestinal ability to metabolize compounds eg condensed tannins and how these catabolites are absorbed into the circulatory system Changes in the catabolite pattern will form the basis for estimation of the intervention period needed when planning a full-scale randomized controlled trial
Research Team
Tonje H Stea Professor University of Agder - Project Leader Rune Slimestad Chemist PhD PlantChem AS - Responsible for metabolite analysis of urine Will provide intervention drink and urine containers to the medical office
Nils Grude Senior Physician PhD Antibiotic Center Ullevål Hospital - Responsible for microbiology expertise
Ståle Tofteland Senior Physician PhD Kristiansand Hospital - Responsible for cultivation and characterization of bacteria in urine
Tor Jakob Rørvik General Practitioner Konsmo - Responsible for participant approval and reception of urine samples
Development of an aronia mixture intervention drink A mixture has been developed consisting of aronia and apple juices 11 ratio and the mixture is concentrated by removing 50 of the liquid content in the form of water Study participants will therefore consume a larger proportion of potential bioactive compounds than the proportion of bioactive compounds available in the equivalent volume of natural aronia juice Apple juice has been added to the mixture in order to created a sweeter more desirable flavor
The mixture is thoroughly characterized in terms of ingredients and a daily dose of 1 g of polyphenols will provide 680 mg of B-type proanthocyanidins 125 mg of anthocyanins and 215 mg of phenolic acids per dL aronia mixture
Estimation of daily dose of aronia-mixture in the present study is based on the content of B-type proanthocyanidins as metabolites of these compounds can provide a natural antibiotic effect on uropathogens Specifically the dosage used in this study has been calculated based on a previous pharmacokinetic study among students at the Univeristy of Oslo unpublished data 2018 in addition to another non-clinical pilot study which has been conducted among nursing home residents in Sandnes municipality 2
A total of 25 women will be recruited based on the following inclusion criteria
More than 18 years of age
Recurrent urinary tract infections rUTI minimum of 2 episodes during the last 6 months or minimum of 3 episodes during the last 12 months
Participants should be cooperative capable of maintaining a patient diary and providing urine samples according to a specified schedule
Exclusion criteria
Use of Hiprex during the last 6 months
Regular use of aronia during the last 6 months
Allergy to heat-treated aronia or apple
Uncontrolled diabetes mellitus
Use of blood-thinning medication eg Warfarin Marevan
For recruitment of participants information about the study will be posted on waiting room walls at Konsmo Doctors Office and through advertisement in local newspapers Prior to study participation written informed approval will be signed by all participants and they will be able to withdraw from the study at any time
During the intervention period study participants will consume 1 dL of the mixture every day for 6 months This is equivalent to approximately half a breakfast glass of liquid The aronia-mixture will preferably be consumed together with a meal or after finishing a meal The mixture may be obtained in the fridge or in room temperature but not heated and study participants may consume the mixture in smaller portions throughout the day Participants will be instructed to keep a patient diary and provide the following information
Deviations from the intervention protocol regarding the frequency and the dosage of aronia-mixture consumed
Observations regarding UTI symptoms should be described ie symptoms of incipient infections duration of symptoms and when the symptoms cease This applies to both untreated UTIs and medically treated infections
Other observations related to UTIs or intake of the aronia-mixture ie changes in urine colour of urine possible adverse effects discomfort etc
For collection of urine samples participants are provided with 10 items of 30 mL polypropylene tubes containing boric acid from the doctors office when entering the pilot study More tubes will be provided if needed The tubes will be labeled with date of delivery and names of study participants when delivering to the doctors office
Urine samples for cultivation
A urine sample will be collected by staff at the doctors office in Konsmo before the intervention period pre-test Additionally a urine sample will be collected every time a urinary tract infection UTI is to be treated with antibiotics during the intervention period De-identified samples will be sent for routine cultivation at Sorlandet Hospital by Dr Ståle Tofteland and willl thereafter be routinely destroyed
Urine samples for metabolite analysis
30 mL urine samples will be collected by staff at the doctors office and sent for analysis of metabolites on day 0 60 120 and 180 of the intervention period De-identified samples will be collected by Dr Rune Slimestad who will also perform analysis continously after collection The samples will be analyzed for phenolic metabolites using UHPLC-MS and quantified relative to urine concentration creatinine De-identified samples can be stored for up to 2 months in a freezer -20 and then completely destroyed
Data analysis
The participants medical history of UTIs 12 months before initiation of the project and during the project period will be obtained from the patients medical journals Additionally a patient diary from the project will provide information about transient untreated infections asymptomatic UTIs other comments regarding the infection course or intervention drinks
The analysis work will focus on the main outcome measures and calculate dropouts from the study changes in the frequency of treated and untreated UTIs and changes in metabotyping
1 Jurikova T et al 2017 Fruits of Black Chokeberry Aronia melanocarpa in the Prevention of Chronic Diseases Molecules226
2 Handeland M et al 2014 Black chokeberry juice Aronia melanocarpa reduces incidences of urinary tract infection among nursing home residents in the long term - a pilot study Nutr Res 34 518-525
Outcomes in the pilot study is number of UTI episodes both treated and untreated corresponding to historical episodes last 12 months characterization of uropathogens from urine culture analyses as well as characterization of phenolic metabolites in urine as a result of the intervention Findings of catabolites based on certain polyphenols will reflect the intestinal ability to metabolize compounds eg condensed tannins and how these catabolites are absorbed into the circulatory system Changes in the catabolite pattern will form the basis for estimation of the intervention period needed when planning a full-scale randomized controlled trial
Research Team
Tonje H Stea Professor University of Agder - Project Leader Rune Slimestad Chemist PhD PlantChem AS - Responsible for metabolite analysis of urine Will provide intervention drink and urine containers to the medical office
Nils Grude Senior Physician PhD Antibiotic Center Ullevål Hospital - Responsible for microbiology expertise
Ståle Tofteland Senior Physician PhD Kristiansand Hospital - Responsible for cultivation and characterization of bacteria in urine
Tor Jakob Rørvik General Practitioner Konsmo - Responsible for participant approval and reception of urine samples
Development of an aronia mixture intervention drink A mixture has been developed consisting of aronia and apple juices 11 ratio and the mixture is concentrated by removing 50 of the liquid content in the form of water Study participants will therefore consume a larger proportion of potential bioactive compounds than the proportion of bioactive compounds available in the equivalent volume of natural aronia juice Apple juice has been added to the mixture in order to created a sweeter more desirable flavor
The mixture is thoroughly characterized in terms of ingredients and a daily dose of 1 g of polyphenols will provide 680 mg of B-type proanthocyanidins 125 mg of anthocyanins and 215 mg of phenolic acids per dL aronia mixture
Estimation of daily dose of aronia-mixture in the present study is based on the content of B-type proanthocyanidins as metabolites of these compounds can provide a natural antibiotic effect on uropathogens Specifically the dosage used in this study has been calculated based on a previous pharmacokinetic study among students at the Univeristy of Oslo unpublished data 2018 in addition to another non-clinical pilot study which has been conducted among nursing home residents in Sandnes municipality 2
A total of 25 women will be recruited based on the following inclusion criteria
More than 18 years of age
Recurrent urinary tract infections rUTI minimum of 2 episodes during the last 6 months or minimum of 3 episodes during the last 12 months
Participants should be cooperative capable of maintaining a patient diary and providing urine samples according to a specified schedule
Exclusion criteria
Use of Hiprex during the last 6 months
Regular use of aronia during the last 6 months
Allergy to heat-treated aronia or apple
Uncontrolled diabetes mellitus
Use of blood-thinning medication eg Warfarin Marevan
For recruitment of participants information about the study will be posted on waiting room walls at Konsmo Doctors Office and through advertisement in local newspapers Prior to study participation written informed approval will be signed by all participants and they will be able to withdraw from the study at any time
During the intervention period study participants will consume 1 dL of the mixture every day for 6 months This is equivalent to approximately half a breakfast glass of liquid The aronia-mixture will preferably be consumed together with a meal or after finishing a meal The mixture may be obtained in the fridge or in room temperature but not heated and study participants may consume the mixture in smaller portions throughout the day Participants will be instructed to keep a patient diary and provide the following information
Deviations from the intervention protocol regarding the frequency and the dosage of aronia-mixture consumed
Observations regarding UTI symptoms should be described ie symptoms of incipient infections duration of symptoms and when the symptoms cease This applies to both untreated UTIs and medically treated infections
Other observations related to UTIs or intake of the aronia-mixture ie changes in urine colour of urine possible adverse effects discomfort etc
For collection of urine samples participants are provided with 10 items of 30 mL polypropylene tubes containing boric acid from the doctors office when entering the pilot study More tubes will be provided if needed The tubes will be labeled with date of delivery and names of study participants when delivering to the doctors office
Urine samples for cultivation
A urine sample will be collected by staff at the doctors office in Konsmo before the intervention period pre-test Additionally a urine sample will be collected every time a urinary tract infection UTI is to be treated with antibiotics during the intervention period De-identified samples will be sent for routine cultivation at Sorlandet Hospital by Dr Ståle Tofteland and willl thereafter be routinely destroyed
Urine samples for metabolite analysis
30 mL urine samples will be collected by staff at the doctors office and sent for analysis of metabolites on day 0 60 120 and 180 of the intervention period De-identified samples will be collected by Dr Rune Slimestad who will also perform analysis continously after collection The samples will be analyzed for phenolic metabolites using UHPLC-MS and quantified relative to urine concentration creatinine De-identified samples can be stored for up to 2 months in a freezer -20 and then completely destroyed
Data analysis
The participants medical history of UTIs 12 months before initiation of the project and during the project period will be obtained from the patients medical journals Additionally a patient diary from the project will provide information about transient untreated infections asymptomatic UTIs other comments regarding the infection course or intervention drinks
The analysis work will focus on the main outcome measures and calculate dropouts from the study changes in the frequency of treated and untreated UTIs and changes in metabotyping
1 Jurikova T et al 2017 Fruits of Black Chokeberry Aronia melanocarpa in the Prevention of Chronic Diseases Molecules226
2 Handeland M et al 2014 Black chokeberry juice Aronia melanocarpa reduces incidences of urinary tract infection among nursing home residents in the long term - a pilot study Nutr Res 34 518-525
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None