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New treatment option for Perimenopause
Official title Impact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being
ClinicalTrials.gov ID: NCT07599930
What this study is testing
- What it's testing
- This is a clinical trial aimed to investigate if a novel phytochemical and fibre-rich snack can improve perimenopausal symptoms and well-being in perimenopausal women aged 40-55 and not on hormone replacement therapy. Hypothesis: The investigators hypothesise that the phytochemical and fibre-rich snack will improve perimenopausal symptoms via a gut microbiota mediated mechanism.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 55, women only. Healthy volunteers may be eligible.
You may be able to join if
- Adults aged 40 to 55
- Score 14 or higher on the Menopause Rating Scale
- For intervention purposes, eligible participants are also required to have a mobile phone and be able to read and speak English.
You likely can't join if
- People who consume more than 15g of fibre a day
- People who consume more than 2 cups of coffee or tea a day
- People who consume more than 4 portions (portion = 80g) of fruits and vegetables a day
- People who do not have any intolerances or allergies to the following:
- Any kinds of nuts including tree nuts, peanuts, hazelnuts and coconuts
- Chia seeds
See the full eligibility criteria
- Adults aged 40 to 55
- Score 14 or higher on the Menopause Rating Scale
- For intervention purposes, eligible participants are also required to have a mobile phone and be able to read and speak English.
- People who consume more than 15g of fibre a day
- People who consume more than 2 cups of coffee or tea a day
- People who consume more than 4 portions (portion = 80g) of fruits and vegetables a day
- People who do not have any intolerances or allergies to the following:
- Any kinds of nuts including tree nuts, peanuts, hazelnuts and coconuts
- Chia seeds
- Pumpkin seeds
- Sunflower seeds
- Dates
- Gluten
- Dairy
- Oats
- Barley
- Soya
- People who smoke or vape or have smoked or vaped in the last 2 years
- People who consume more than 21 drinks a week or have a history of excess alcohol intake
- People with comorbid conditions that may limit participation in the study, such as a history of an acute cardiovascular event, including coronary artery disease, previous myocardial infarction (heart attack), stroke...
- 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) or aspirin
- People taking antihypertensive drugs
- People who take antibiotics or bacterial agents (Probiotics) within 1 month
- People who take vitamin/dietary supplements within 1 month
- Pregnant women, women ready for pregnancy, and nursing mothers
- cardiac arrhythmia
- renal failure
- heart failure (NYHA II-IV)
- diabetes mellitus
- Malignant disease
- People who have participated in a biomedical study within the past 3 months
- Women who require hormone replacement therapy during the development of the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- London, London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.