Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Menopause is one of the most significant lifecourse challenges for women. The decline in female sex hormones, in particular estrogen, during menopause leads to an increased risk in cardiometabolic diseases, and a decrease in quality of life due to symptoms such as low mood, anxiety, hot flushes and difficulty sleeping. As life expectancy continues to increase, on average, women will spend one third of their life in the postmenopausal period. Increasing evidence suggests that the gut microbiota plays a key role in menopause-related symptoms and conditions, being one of the main regulators of circulating sex hormones. Menopause has been linked to gut dysbiosis and lower gut microbial diversity, therefore nutritional strategies targeting the gut microbiome may be an effective approach to improve women's health during menopause. Both (poly)phenols and probiotics are promising candidates for the prevention and treatment of menopausal symptoms via different mechanisms, including the modulation of the gut-brain axis, while emerging evidence indicates that using both together may be a better approach than traditional carbohydrate-based synbiotics. To our knowledge, the efficacy of a (poly)phenol based synbiotic targeting the gut microbiome for improvement of menopausal symptoms has not been investigated so far.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 48
Maximum Age: 60
Healthy Volunteers: t
View:

• Adults \>48 years

• Post-menopausal female subjects without clinical signs or symptoms of cardiovascular disease, no menstruation cycle for more than 1 year, postmenopausal status conformed by female hormone analysis

• For intervention purposes, eligible participants are also required to have a mobile phone and be able to read and speak English.

Locations
Other Locations
United Kingdom
Adele Costabile
RECRUITING
London
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
RECRUITING
London
Contact Information
Primary
ADELE COSTABILE
adele.costabile@roehampton.ac.uk
+44 (0)20 8392 3571
Backup
ANA MATEOS-RODRIGUEZ, DR
ana.rodriguez-mateos@kcl.ac.uk
02078484349
Time Frame
Start Date: 2024-03-18
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 30
Treatments
Experimental: Mixture of (Poly)phenols and a probiotic supplement
This is a Mixture of (Poly)phenols and a probiotic supplement
Placebo_comparator: (Poly)phenols and maltodextrin
This is a mixture of (Poly)phenols and maltodextrin (placebo comparator)
Related Therapeutic Areas
Sponsors
Collaborators: King's College
Leads: University of Roehampton

This content was sourced from clinicaltrials.gov