Impact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-55
SponsorKing's College London
About this trial
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.
Main research questions:
Does eating the snack every day lower menopause symptoms such as hot flushes, night sweats, mood changes, and sleep problems? Does the snack improve mood, stress, anxiety, sleep, and overall quality of life? Does the snack improve the balance of bacteria in the gut, and could this be part of how it helps symptoms?
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Any kinds of nuts including tree nuts, peanuts, hazelnuts and coconuts
Trial design
Treatments tested in this trial
- Functional Snacks
- Placebo Snacks
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
King's College London
Lead sponsor
Tulā Code Ltd
Collaborator
Source ClinicalTrials.gov