Impact of Oral Supplementation With Bioactive Collagen Peptides and Other Functional Ingredients

NCT ID: NCT07151482

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-02-28

Brief Summary

Genitourinary Syndrome of Menopause (GSM), characterized by vaginal dryness, pain, urinary incontinence, and other symptoms, can be mitigated through both hormonal and non-hormonal treatments. Collagen peptides have shown promising results in improving skin, cartilage, and exhibiting antioxidative activities in studies. This study evaluates changes of quality of life and sexual function, related to vulvovaginal atrophy (VVA) and initial urinary incontinence (UI) in women with GSM symptoms, with the intake of a daily oral food supplement containing 2.5 g of Bioactive Collagen Peptides (BCP®) and other functional ingredients over a 16-week period . This can represent a new therapeutic option for these patients, particularly when hormonal therapy is not an option.

Detailed Description

Genitourinary Syndrome of Menopause (GSM) includes a variety of symptoms related to the decline of circulating ovarian hormones. The syndrome is characterized by complaints of vaginal dryness, dyspareunia, pain, urinary incontinence, and recurrent urinary tract infections.

Collagen hydrolysate (CH) has been used in pharmaceuticals and food supplements for improving skin and cartilage tissues. It is absorbed in the digestive tract, appears in the human blood partly in a small peptide form. Based on in vitro studies, collagen peptides (CPs) have shown to exert potent antioxidative activities in different oxidative systems.

The purpose of this study is to evaluate the improvement of quality of life, vulvovaginal atrophy (VVA) and of initial Urinary Incontinence (UI) in menopausal women with GSM symptoms following oral administration of a food supplement treatment containing 2.5 g of BCP® and other functional ingredients taken once daily over a period of 16 weeks. The improvement of systemic health state and satisfaction with this supplement will be evaluated using both subjective and objective measures.

The aim is also to identify significant improvement in quality of sexual function and health of genitourinary system.

Conditions

Genitourinary Syndrome of Menopause

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Collagendep

The purpose of this study is to evaluate the improvement of quality of life, vulvovaginal atrophy (VVA) and of initial Urinary Incontinence (UI) in menopausal women with GSM symptoms following oral administration of a food supplement treatment containing 2.5 g of BCP® and other functional ingredients taken once daily over a period of 16 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

QOL questionnaires

Eligibility Criteria

Inclusion Criteria

• Menopausal women (at least 12 months since last menstrual period or bilateral oophorectomy)
• Patients with Genitourinary Syndrome and the presence of vulvovaginal atrophy/vestibular trophism alteration (defined as Vaginal Health Index - VHI - less than 15; and Vestibular Trophic Health Score - VeTH - more than 5) and/or initial urinary incontinence based on patient history (stress incontinence , urge incontinence, nicturia reported by patients,) positive IU tests (Stamey score 1: loss of urine with sudden increase in abdominal pressure such as from coughing, sneezing, or laughing) and on a standardized stress test provocation [(cough test supine and in a standing position with a full bladder (300 ml)] in healthy post-menopausal women and/or positive OABSS score for overactive bladder.
• Patients willing to provide Informed consent to participate in the study.
• Women aged between 45 and 65 years.

Exclusion Criteria

• Renal insufficiency or sever nephropathy.
• In case of known hypersensitivity to one or more of the components contained in the food supplement.
• Active or recent (30 days) genitourinary tract infection.
• Abnormal uterine bleeding.
• Use of lubricants or any other local or systemic preparations, within the 30 days prior to the study.
• Genital prolapse (grade II - III according to the Pelvic Organ Prolapse-Quantification, POP-Q, system classification).
• Serious or chronic condition that could interfere with study compliance.
• Treatment with hormones or other medicines to relieve menopausal symptoms within the 3 months prior the study.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paola Villa

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Central Contacts

Paola Villa

Role: CONTACT

paola.villa@policlinicogemelli.it

+39 3392318208

Other Identifiers

7441

Identifier Type: -

Identifier Source: org_study_id