NCT05730998

Brief Summary

This research aims to evaluate the potential benefit of an oral nutritional supplement based on Anthocran phytosome compared to placebo on the prevention of urinary infections, including microbiota analyzes, in postmenopausal women (\> 70 years) with diabetes. For each subject enrolled, all parameters relating to urinary infections will be assessed at the beginning (baseline), every 2 months from the start of treatment and at the end of treatment (6 months), with urine analysis and quality of life questionnaires.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

February 7, 2023

Last Update Submit

February 15, 2023

Conditions

DiabetesUrinary Infection

Outcome Measures

Primary Outcomes (3)

  • urinalysis

    Urinalysis included color, specific gravity, pH, glucose, protein, red blood cell, white blood cell. Microscopic examinations were performed under a clinical light microscope (Olympus Opto Systems India Pvt. Ltd. New Delhi, India).

    At baseline

  • urinalysis

    Urinalysis included color, specific gravity, pH, glucose, protein, red blood cell, white blood cell. Microscopic examinations were performed under a clinical light microscope (Olympus Opto Systems India Pvt. Ltd. New Delhi, India).

    After two months of treatment

  • urinalysis

    Urinalysis included color, specific gravity, pH, glucose, protein, red blood cell, white blood cell. Microscopic examinations were performed under a clinical light microscope (Olympus Opto Systems India Pvt. Ltd. New Delhi, India).

    After four months of treatment

Secondary Outcomes (4)

  • urine culture

    At baseline

  • urine culture

    After two months of treatment

  • urine culture

    After four months of treatment

  • urine culture

    After six months of treatment

Study Arms (2)

Intervention group

EXPERIMENTAL

1 capsule (120 mg) of Anthocran phytosome will be taken 1 times a day, for 6 months, with control every 2 months and phone call every month of treatment.

Dietary Supplement: ANTHOCRAN FITOSOMA

Placebo group

PLACEBO COMPARATOR

1 capsule of placebo will be taken 1 times a day, for 6 months, with control every 2 months and phone call every month of treatment.

Dietary Supplement: PLACEBO

Interventions

ANTHOCRAN FITOSOMADIETARY_SUPPLEMENT

The product (Anthocran phytosome or placebo) will be taken in the quantity of 1 capsule of 120 mg, 1 times a day, for 6 months

Intervention group
PLACEBODIETARY_SUPPLEMENT

Placebo will be taken in the quantity of 1 capsule of 120 mg, 1 times a day, for 6 months

Placebo group

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • postmenopausal women (\> 70 years) with diabetes.
  • treatment with SGLT-2 inhibitors
  • disease duration for at least 10 years, with at least 1 episode of infection the previous year and Charlson's co-morbidity index\> 6.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Diabetes MellitusUrinary Tract Infections

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 16, 2023

Study Start

September 1, 2022

Primary Completion

December 31, 2022

Study Completion

January 31, 2023

Last Updated

February 16, 2023

Record last verified: 2023-02

Locations

IT(1)