Using polyphenols and probiotics to alleviate menopausal symptoms
Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis
This study is testing if a mix of polyphenols and probiotics can help relieve menopausal symptoms in postmenopausal women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 48 Years to 60 Years |
| Sex | Female |
| Sponsor | University of Roehampton Academic / other |
| Locations | 2 sites (London, UK and 1 other locations) |
| Trial ID | NCT06333223 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a combination of polyphenols and probiotics on menopausal symptoms in postmenopausal women. It employs a double-blind randomized crossover design involving 30 participants, who will consume either the active supplements or a placebo for 8 weeks. The research aims to explore how these interventions may improve mood, anxiety, and other symptoms through mechanisms related to the gut microbiota. The study is designed to provide insights into nutritional strategies that could enhance women's health during menopause.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women over 48 years old without significant cardiovascular disease or other major health issues.
Not a fit: Patients with comorbid conditions such as uncontrolled hypertension, cancer, or those currently on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for women experiencing menopausal symptoms.
How similar studies have performed: While the specific combination of polyphenols and probiotics is novel, previous studies have shown promising results in using probiotics to improve gut health and related symptoms.
Eligibility criteria
Show full inclusion / exclusion 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-menopausal female subjects without clinical signs or symptoms of cardiovascular disease * acute inflammation * cardiac arrhythmia * renal failure * heart failure (NYHA II-IV) * diabetes mellitus * C-reactive protein \> 0.5 mg/dL * malignant disease * hypotension (≤100 / 60 mm Hg) * Women who require hormone replacement therapy during the development of the protocol.
Where this trial is running
London, UK and 1 other locations
- Health Sciences Research Centre, Life Sciences Department, University of Roehampton — London, UK, United Kingdom (Recruiting)
- Adele Costabile — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Adele Costabile
- Email: adele.costabile@roehampton.ac.uk
- Phone: +44 (0)20 8392 3571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.