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Recruiting NCT06333223

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

Trial Parameters

Condition Menopause
Sponsor University of Roehampton
Study Type INTERVENTIONAL
Phase N/A
Enrollment 30
Sex FEMALE
Min Age 48 Years
Max Age 60 Years
Start Date 2024-03-18
Completion 2025-12-18
Interventions
Mixture of (Poly)phenols and a probiotic supplementPlacebo comparator

Brief 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 Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * • People with comorbid conditions that may limit participation in the study, such as a history of an acute cardiovascular event, uncontrolled hypertension, cancer or major psychiatric or cognitive problems * People who are already participating in a weight loss programme * People receiving drug treatment for lipid metabolisms (e.g., statins * People with a history of long-term use of medicines known to influence glucose metabolism (e.g., corticosteroids) * People who take antibiotics or bacterial agents (Probiotics) within 1 month * Pregnant women, women ready for pregnancy, and nursing mothers * Post

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