Menopause Clinical Trials

Find Menopause Clinical Trials Near You

Impact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being: a Randomised, Double-blinded, Placebo-controlled, Crossover Trial

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 40
Maximum Age: 55
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
United Kingdom
Metabolic Research Unit (KCL, Waterloo Campus)
RECRUITING
London
Contact Information
Primary
Ana Rodriguez-Mateos, PhD
ana.rodriguez-mateos@kcl.ac.uk
+44 (0)20 7848 4349
Backup
Zicheng Zhang, PhD
swap@kcl.ac.uk
+44 (0)20 7848 0313
Time Frame
Start Date: 2026-04-24
Estimated Completion Date: 2026-12
Participants
Target number of participants: 20
Treatments
Experimental: functional snacks then placebo snacks
Daily consumption of 2 pouches of function snacks (50 g per pouch, rich in phytochemicals and fibres) for 28 days, then crossing over to the placebo snacks
Experimental: placebo snacks then functional snacks
Daily consumption of 2 pouches of placebo snacks (50 g per pouch, less in phytochemicals and fibres) for 28 days, then crossing over to the functional snacks
Related Therapeutic Areas
Sponsors
Leads: King's College London
Collaborators: Tulā Code Ltd

This content was sourced from clinicaltrials.gov