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RECRUITING
NCT06333223
NA

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

Sponsor: University of Roehampton

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

48 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-03-18

Completion Date

2026-11-01

Last Updated

2025-02-27

Healthy Volunteers

Yes

Conditions

Interventions

DIETARY_SUPPLEMENT

Mixture of (Poly)phenols and a probiotic supplement

Mixture of (Poly)phenols and a probiotic supplement

DIETARY_SUPPLEMENT

Placebo comparator

Mixture of (Poly)phenols and a placebo maltodextrin comparator

Locations (2)

Health Sciences Research Centre, Life Sciences Department, University of Roehampton

London, UK, United Kingdom

Adele Costabile

London, United Kingdom