NCT06333223

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Roehampton · Academic / Other
• Sex: Female
• Age: 48 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

The main aim of this work is to investigate whether a combination of (poly)phenols and probiotics will improve mood, anxiety and other menopausal symptoms via a gut microbiota related mechanism. This is a double-blind randomized crossover study with a total of 30 postmenopausal women (i.e participants will be divided into two groups with 15 participants in each group) and will test the effects of 8-week daily consumption of either a combination of a (poly)phenol supplement specifically designed to target the gut microbiota and a probiotic supplement specifically designed to target the gut-brain axis or the the (poly)phenol supplement and maltodextrin (placebo).

Conditions

• Menopause

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-18
• Primary completion: 2025-12-18
• Completion: 2026-11-01
• First posted: 2024-03-27
• Last updated: 2025-02-27

Locations

2 sites across 1 country: United Kingdom