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

Menopause Clinical Trial

— SYMPTOGUT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06333223
• Other study ID #: LSC 23/ 396
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: March 2024
• Source: University of Roehampton
• Contact: ADELE COSTABILE
• Phone: +44 (0)20 8392 3571
• Email: adele.costabile[@]roehampton.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 30, 2025
• Est. primary completion date: December 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 48 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopause

Intervention

Dietary Supplement:
• Mixture of (Poly)phenols and a probiotic supplement
Mixture of (Poly)phenols and a probiotic supplement
• Placebo comparator
Mixture of (Poly)phenols and a placebo maltodextrin comparator

Locations

Country	Name	City	State
United Kingdom	Adele Costabile	London
United Kingdom	Health Sciences Research Centre, Life Sciences Department, University of Roehampton	London	UK

Sponsors (2)

Lead Sponsor	Collaborator
University of Roehampton	King's College

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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