Actively Recruiting
Impact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being: a Randomised, Double-blinded, Placebo-controlled, Crossover Trial
Led by King's College London · Updated on 2026-05-20
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
K
King's College London
Lead Sponsor
T
Tulā Code Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a novel phytochemical- and fibre-rich granola snack to see if it can improve symptoms and well-being in perimenopausal women aged 40 to 55 who are not using hormone replacement therapy. This randomized, double-blind, placebo-controlled crossover trial aims to find out if daily consumption of the snack reduces menopause symptoms like hot flushes, night sweats, mood changes, and sleep problems, possibly through changes in gut bacteria. Participants will consume either the intervention snack or a calorie-matched placebo snack twice daily for 4 weeks, then switch to the other snack after a 4-week washout. The intervention snack contains various seeds, nuts, fruits, and spices, while the placebo is a commercially available oat-based chocolate snack with fewer fibres and polyphenols. The crossover design allows comparison of effects within the same participants. During the 12-week study, participants will attend four visits for measurements and sample collection including saliva, urine, and stool to assess cortisol and gut microbiome. They will complete online and paper questionnaires evaluating mood, anxiety, cognition, stress, physical activity, sleep quality, and quality of life. Vital signs and blood samples will also be collected. The main outcome is change in menopause symptoms measured by the Menopause Rating Scale after 4 weeks of snack consumption.
CONDITIONS
Brief Title
Impact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 40 to 55
- Score 14 or higher on the Menopause Rating Scale
- Must have a mobile phone and be able to read and speak English
You will not qualify if you...
- Consume more than 15g of fibre per day
- Consume more than 2 cups of coffee or tea per day
- Consume more than 4 portions (80g each) of fruits and vegetables per day
- Allergies or intolerances to nuts, chia seeds, pumpkin seeds, sunflower seeds, dates, gluten, dairy, oats, barley, or soya
- Smoke or vape currently or within the last 2 years
- Consume more than 21 alcoholic drinks per week or have a history of excess alcohol intake
- Have comorbid conditions such as cardiovascular disease, diabetes, kidney disease, metabolic syndrome, malignancies, cardiac arrhythmia, renal failure, heart failure, uncontrolled hypertension, major psychiatric or cognitive problems
- Receiving drug treatment for lipid metabolism (e.g., statins)
- Long-term use of medicines affecting glucose metabolism or aspirin
- Taking antihypertensive drugs
- Use of antibiotics, probiotics, or dietary supplements within 1 month
- Pregnant, planning pregnancy, or nursing
- Participated in a biomedical study within past 3 months
- Require hormone replacement therapy during study
- Have cardiac arrhythmia, renal failure, heart failure (NYHA II-IV), diabetes mellitus, or malignant disease
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks (including 4 weeks of first snack, 4 weeks washout, and 4 weeks of second snack)
Participants consume either the functional snack or a calorie-matched placebo snack twice daily for 4 weeks while maintaining their usual diet and physical activity, followed by a 4-week washout period before crossing over to the alternate snack for another 4 weeks.
4 visits (in-person) at baseline, 4 weeks, 8 weeks, and 12 weeks
Trial Site Locations
Total: 1 location
1
Metabolic Research Unit (KCL, Waterloo Campus)
London, London, United Kingdom, SE1 9NH
Actively Recruiting
Research Team
A
Ana Rodriguez-Mateos, PhD
Z
Zicheng Zhang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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