Clinical trial NCT06333223: Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis
Official title: Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Menopause
Lead sponsor: University of Roehampton
Sponsor class: OTHER
Collaborators: name: King's College
First posted: 2024-03-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 48
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Arm 1: Mixture of (Poly)phenols and a probiotic supplement Arm 2: (Poly)phenols and maltodextrin (placebo)
Primary purpose: OTHER

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).

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.

Primary outcomes:
measure: Change in blood chemistry levels
timeFrame: Change from baseline to 8 and 16 weeks of the intervention
Secondary outcomes:
measure: Change in BMI (body mass index) Scores
timeFrame: Change from baseline to 8 and 16 weeks of the intervention
measure: Change in the gut microbiota diversity
timeFrame: Change from baseline to 8 and 16 weeks of the intervention
measure: Change in dietary habits
timeFrame: Change from baseline to 8 and 16 weeks of the intervention
measure: Change in Quality IPAQ
timeFrame: Change from baseline to 8 and 16 weeks of the intervention
measure: Change in inflammatory biomarkes
timeFrame: Change from baseline to 8 and 16 weeks of the intervention
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Health Sciences Research Centre, Life Sciences Department, University of Roehampton
state: UK
city: London
country: United Kingdom
facility: Adele Costabile
Study officials:
affiliation: University of Roehampton
name: ADELE COSTABILE
role: STUDY_DIRECTOR
References: