Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Change in blood chemistry levels
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 48 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •• 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.
研究组 & 干预措施
Mixture of (Poly)phenols and a probiotic supplement
This is a Mixture of (Poly)phenols and a probiotic supplement
干预措施: Mixture of (Poly)phenols and a probiotic supplement (Dietary Supplement)
(Poly)phenols and maltodextrin
This is a mixture of (Poly)phenols and maltodextrin (placebo comparator)
干预措施: Placebo comparator (Dietary Supplement)
结局指标
主要结局
Change in blood chemistry levels
时间窗: 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
次要结局
- Change in dietary habits(Change from baseline to 8 and 16 weeks of the intervention)
- Change in inflammatory biomarkes(Change from baseline to 8 and 16 weeks of the intervention)
- Change in BMI (body mass index) Scores(Change from baseline to 8 and 16 weeks of the intervention)
- Change in Quality IPAQ(Change from baseline to 8 and 16 weeks of the intervention)
- Change in the gut microbiota diversity(Change from baseline to 8 and 16 weeks of the intervention)
- Change in SCFAs metabolites (mmol/L)(Change from baseline to 8 and 16 weeks of the intervention)
研究者
DR ADELE COSTABILE
Prof
University of Roehampton