Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333223
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-20
Brief Title:
Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis
Sponsor:
University of Roehampton
Organization:
University of Roehampton
Study Overview
Official Title:
Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SYMPTOGUT
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 womens health during menopause Both polyphenols 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 polyphenol based synbiotic targeting the gut microbiome for improvement of menopausal symptoms has not been investigated so far
To our knowledge the efficacy of a polyphenol 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 polyphenols 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 ie 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 polyphenol supplement specifically designed to target the gut microbiota and a probiotic supplement specifically designed to target the gut-brain axis or the the polyphenol supplement and maltodextrin placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None