NCT07151482

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

Impact of Oral Supplementation With Bioactive Collagen Peptides and Other Functional Ingredients on Quality of Life, Related to Vaginal Atrophy and Urinary Incontinence Inwomen With Genitourinary Syndrome of Menopause (GSM)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 43 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-09-01
• Completion: 2028-02-28
• First posted: 2025-09-03
• Last updated: 2025-09-03