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

What this trial studies

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.

Conditions in scope

• Menopause

Interventions

• Mixture of (Poly)phenols and a probiotic supplement (Dietary Supplement) — Mixture of (Poly)phenols and a probiotic supplement
• Placebo comparator (Dietary Supplement) — Mixture of (Poly)phenols and a placebo maltodextrin comparator

Who can join

Women only · Ages 48 Years to 60 Years · Accepts healthy volunteers.

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-menopausal female subjects without clinical signs or symptoms of cardiovascular disease
• acute inflammation

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2024-03-18
• Primary completion: 2025-12-18
• Last update posted: 2026-05-07
• First posted: 2024-03-27

Sponsor & contact

Lead sponsor: University of Roehampton (Other)

Collaborators: King's College

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change in blood chemistry levels (Change from baseline to 8 and 16 weeks of the intervention)
  To investigate whether a combination of (poly)phenols and probiotics intervention lowers the blood chemitry parameters compared to the baseline

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.