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

Last updated: February 24, 2025
Sponsor: University of Roehampton
Overall Status: Active - Recruiting

Phase

N/A

Condition

Menopause

Treatment

Placebo comparator

Mixture of (Poly)phenols and a probiotic supplement

Clinical Study ID

NCT06333223
LSC 23/ 396
  • Ages 48-60
  • Female
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Adults >48 years

  • Post-menopausal female subjects without clinical signs or symptoms of cardiovasculardisease, no menstruation cycle for more than 1 year, postmenopausal status conformedby female hormone analysis

  • For intervention purposes, eligible participants are also required to have a mobilephone and be able to read and speak English.

Exclusion

Exclusion Criteria:

  • • People with comorbid conditions that may limit participation in the study, such asa history of an acute cardiovascular event, uncontrolled hypertension, cancer ormajor 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 glucosemetabolism (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 ofcardiovascular 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 theprotocol.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Placebo comparator
Phase:
Study Start date:
March 18, 2024
Estimated Completion Date:
November 01, 2026

Study 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).

Connect with a study center

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

    London, UK SW15 4JD
    United Kingdom

    Active - Recruiting

  • Adele Costabile

    London, SW145JD
    United Kingdom

    Active - Recruiting

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