MenopauseSYMPTOGUTNCT06333223
Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis
A study testing Mixture of (Poly)phenols and a probiotic supplement in people with Menopause, run by University of Roehampton at 2 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 48 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Mixture of (Poly)phenols and a probiotic supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 18 Mar 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- • 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
Show all 16Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, SW15 4JD
Adele Costabile
London, SW145JD
About this study
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.
Read the 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).
- Conditions
- Menopause
- Being tested
- Mixture of (Poly)phenols and a probiotic supplement, Placebo comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixture of (Poly)phenols and a probiotic supplementDietary supplement
Mixture of (Poly)phenols and a probiotic supplement
Placebo comparatorDietary supplement
Also called (Poly)phenols and maltodextrin
Mixture of (Poly)phenols and a placebo maltodextrin comparator
| Study group | Role | What they receive |
|---|---|---|
| Mixture of (Poly)phenols and a probiotic supplement | Experimental | This is a Mixture of (Poly)phenols and a probiotic supplement Receives: 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) Receives: Dietary Supplement: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline to 8 and 16 weeks of the intervention
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Change from baseline to 8 and 16 weeks of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start18 Mar 2024
- Primary completion18 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Arm 1: Mixture of (Poly)phenols and a probiotic supplement Arm 2: (Poly)phenols and maltodextrin (placebo)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Collaborators
- King's College
- Responsible party
- Principal investigator, DR ADELE COSTABILE, University of Roehampton
- Investigators
- ADELE COSTABILE, Study director, University of Roehampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333223
- Sponsor's protocol ID
- LSC 23/ 396
- Acronym
- SYMPTOGUT
- Status last verified
- May 2026
- First submitted
- 20 Mar 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis
- ClinicalTrials.gov ID
- NCT06333223
- Acronym / sponsor ID
- SYMPTOGUT / LSC 23/ 396
- Conditions
- Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Collaborators
- King's College
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Arm 1: Mixture of (Poly)phenols and a probiotic supplement Arm 2: (Poly)phenols and maltodextrin (placebo)
| Arm | Type | Receives |
|---|---|---|
| Mixture of (Poly)phenols and a probiotic supplement | Experimental | Dietary Supplement: Mixture of (Poly)phenols and a probiotic supplementThis is a Mixture of (Poly)phenols and a probiotic supplement |
| (Poly)phenols and maltodextrin | Placebo comparator | Dietary Supplement: Placebo comparatorThis is a mixture of (Poly)phenols and maltodextrin (placebo comparator) |
Who may qualify
- Ages
- 48 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- • 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixture of (Poly)phenols and a probiotic supplementMixture of (Poly)phenols and a probiotic supplement | Dietary supplement | Mixture of (Poly)phenols and a probiotic supplement |
| Placebo comparatorAlso: (Poly)phenols and maltodextrinMixture of (Poly)phenols and a placebo maltodextrin comparator | Dietary supplement | (Poly)phenols and maltodextrin |
Primary outcome
Change in blood chemistry levels
Time frame: Change from baseline to 8 and 16 weeks of the intervention
To investigate whether a combination of (poly)phenols and probiotics intervention lowers the blood chemitry parameters compared to the baseline
6 secondary outcomes
Change in BMI (body mass index) Scores
Time frame: Change from baseline to 8 and 16 weeks of the intervention
Change in the gut microbiota diversity
Time frame: Change from baseline to 8 and 16 weeks of the intervention
Change in dietary habits
Time frame: Change from baseline to 8 and 16 weeks of the intervention
Change in Quality IPAQ
Time frame: Change from baseline to 8 and 16 weeks of the intervention
Change in inflammatory biomarkes
Time frame: Change from baseline to 8 and 16 weeks of the intervention
Change in SCFAs metabolites (mmol/L)
Time frame: Change from baseline to 8 and 16 weeks of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ADELE COSTABILE study director
University of Roehampton
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixture of (Poly)phenols and a probiotic supplement in people with Menopause, run by University of Roehampton at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood chemistry levels (time frame: Change from baseline to 8 and 16 weeks of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.