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

NCT ID: NCT06333223

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-18
• Study Completion Date: 2026-11-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Mixture of (Poly)phenols and a probiotic supplement

This is a Mixture of (Poly)phenols and a probiotic supplement

Group Type: EXPERIMENTAL

Mixture of (Poly)phenols and a probiotic supplement

Intervention Type: DIETARY_SUPPLEMENT

Mixture of (Poly)phenols and a probiotic supplement

(Poly)phenols and maltodextrin

This is a mixture of (Poly)phenols and maltodextrin (placebo comparator)

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: DIETARY_SUPPLEMENT

Mixture of (Poly)phenols and a placebo maltodextrin comparator

Interventions

Mixture of (Poly)phenols and a probiotic supplement

Mixture of (Poly)phenols and a probiotic supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo comparator

Mixture of (Poly)phenols and a placebo maltodextrin comparator

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

(Poly)phenols and maltodextrin

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-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.

• Minimum Eligible Age: 48 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

King's College

OTHER

Sponsor Role: collaborator

University of Roehampton

OTHER

Sponsor Role: lead

Responsible Party

DR ADELE COSTABILE

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ADELE COSTABILE

Role: STUDY_DIRECTOR

University of Roehampton

Locations

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

London, UK, United Kingdom

Site Status: RECRUITING

Adele Costabile

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

ADELE COSTABILE

Role: CONTACT

adele.costabile@roehampton.ac.uk

+44 (0)20 8392 3571

ANA MATEOS-RODRIGUEZ, DR

Role: CONTACT

ana.rodriguez-mateos@kcl.ac.uk

02078484349

Facility Contacts

Adele Costabile

Role: primary

Adele Costabile, Prof

Role: primary

Other Identifiers

LSC 23/ 396

Identifier Type: -

Identifier Source: org_study_id