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| Name | Class |
|---|---|
| King's College | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mixture of (Poly)phenols and a probiotic supplement | Experimental | This is a Mixture of (Poly)phenols and a probiotic supplement |
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| (Poly)phenols and maltodextrin | Placebo Comparator | This is a mixture of (Poly)phenols and maltodextrin (placebo comparator) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mixture of (Poly)phenols and a probiotic supplement | Dietary Supplement | Mixture of (Poly)phenols and a probiotic supplement |
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| 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 |
| 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 |
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Inclusion Criteria:
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
Menopause Female Women
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| Name | Affiliation | Role |
|---|---|---|
| ADELE COSTABILE | University of Roehampton | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Research Centre, Life Sciences Department, University of Roehampton | London | UK | SW15 4JD | United Kingdom | ||
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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Arm 1: Mixture of (Poly)phenols and a probiotic supplement Arm 2: (Poly)phenols and maltodextrin (placebo)
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| Placebo comparator | Dietary Supplement | Mixture of (Poly)phenols and a placebo maltodextrin comparator |
|
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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 |
| Adele Costabile |
| London |
| SW145JD |
| United Kingdom |