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

NCT06333223 | Recruiting

• 1 other identifier: LSC 23/ 396
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Menopause

Outcome Measures

Primary Outcomes (1)

• Change in blood chemistry levels

  To investigate whether a combination of (poly)phenols and probiotics intervention lowers the blood chemitry parameters compared to the baseline

  Change from baseline to 8 and 16 weeks of the intervention

Secondary Outcomes (5)

• Change in BMI (body mass index) Scores

  Change from baseline to 8 and 16 weeks of the intervention

• Change in the gut microbiota diversity

  Change from baseline to 8 and 16 weeks of the intervention

• Change in dietary habits

  Change from baseline to 8 and 16 weeks of the intervention

• Change in Quality IPAQ

  Change from baseline to 8 and 16 weeks of the intervention

• Change in inflammatory biomarkes

  Change from baseline to 8 and 16 weeks of the intervention

Study Arms (2)

Mixture of (Poly)phenols and a probiotic supplement

EXPERIMENTAL

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

Dietary Supplement: Mixture of (Poly)phenols and a probiotic supplement

(Poly)phenols and maltodextrin

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo comparator

Interventions

Mixture of (Poly)phenols and a probiotic supplement DIETARY_SUPPLEMENT

Mixture of (Poly)phenols and a probiotic supplement

Mixture of (Poly)phenols and a probiotic supplement

Placebo comparator DIETARY_SUPPLEMENT

Mixture of (Poly)phenols and a placebo maltodextrin comparator

Also known as: (Poly)phenols and maltodextrin

(Poly)phenols and maltodextrin

Eligibility Criteria

• Age: 48 Years - 60 Years
• Gender Eligibility Details: Menopause Female Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Roehampton: lead
• King's College: collaborator

Study Sites (2)

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

London, UK, SW15 4JD, United Kingdom

RECRUITING

Adele Costabile

London, SW145JD, United Kingdom

RECRUITING

MeSH Terms

Interventions

maltodextrin

Study Officials

• ADELE COSTABILE

  University of Roehampton

  STUDY DIRECTOR

Central Study Contacts

ADELE COSTABILE

CONTACT

+44 (0)20 8392 3571; adele.costabile@roehampton.ac.uk

ANA MATEOS-RODRIGUEZ, DR

CONTACT

02078484349; ana.rodriguez-mateos@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: Arm 1: Mixture of (Poly)phenols and a probiotic supplement Arm 2: (Poly)phenols and maltodextrin (placebo)

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: March 18, 2024
• Primary Completion: December 18, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 27, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)