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

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.

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Dietary supplement: Mixture of (Poly)phenols and a probiotic supplement; Dietary supplement: Placebo comparator

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 16 postmenopausal women (i.e participants will be divided into two groups with 8 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).

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW145JD
    • Adele Costabile
  • UK
    • London, UK, United Kingdom, SW15 4JD
      • Health Sciences Research Centre, Life Sciences Department, University of Roehampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mixture of (Poly)phenols and a probiotic supplement; This is a 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: (Poly)phenols and maltodextrin; This is a mixture of (Poly)phenols and maltodextrin (placebo comparator)	Dietary supplement: Placebo comparator; Mixture of (Poly)phenols and a placebo maltodextrin comparator; Other Names: (Poly)phenols and maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI (body mass index) Scores	To test whether a combination of (poly)phenols and probiotics intervention affect body mass index express in kg/m^2	Change from baseline to 8 and 16 weeks of the intervention
Change in the gut microbiota diversity	To test whether a combination of (poly)phenols and probiotics intervention impact on the faecal microbiota composition and microbial composition express as ratio compared to the baseline levels	Change from baseline to 8 and 16 weeks of the intervention
Change in dietary habits	To test whether a combination of (poly)phenols and probiotics intervention impact an assessment of dietary intake in the study population using a validated four-day food diary compared to the baseline levels	Change from baseline to 8 and 16 weeks of the intervention
Change in Quality IPAQ	To test whether a combination of (poly)phenols and probiotics intervention impact an assessment of physical activity questionnaire in the study population using a validated four-day food diary compared to the baseline levels	Change from baseline to 8 and 16 weeks of the intervention
Change in inflammatory biomarkes	To test whether a combination of (poly)phenols and probiotics intervention impact CRP, IL10,IL-6 and INFY levels in the study population using ELISA immunoassays compared to the baseline levels	Change from baseline to 8 and 16 weeks of the intervention
Change in SCFAs metabolites (mmol/L)	To test whether a combination of (poly)phenols and probiotics intervention impact SCFAs profile in the study population using LCMS compared to the baseline levels.	Change from baseline to 8 and 16 weeks of the intervention

Collaborators and Investigators

• Sponsor: University of Roehampton
• Collaborators: King's College
• Investigators: Study Director: ADELE COSTABILE, University of Roehampton

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Actual): December 18, 2025
• Study Completion (Actual): January 1, 2026

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Pharmaceutical Solutions; Anti-Infective Agents, Local; Disinfectants; Sclerosing Solutions; maltodextrin
• Other Study ID Numbers: LSC 23/ 396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No