Impact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being

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This double-blind, randomised, placebo-controlled crossover trial will assess the effects of daily consumption for 4 weeks of a novel phytochemical- and fibre-rich granola snack created by TulaCode on menopausal symptoms. The effects of the snack will be compared to a calorie-matched placebo snack: a commercially available oat bar low in fibre and polyphenols. The study will also examine the impact of the intervention snack on mood, stress, sleep quality, cognition, depression and anxiety. Participants will be randomly assigned to either the intervention or the placebo snack for 4 weeks followed by a 4-week washout period before crossing over to the alternate snack for another 4 week period. Snacks will be consumed twice daily, and participants will be instructed to maintain their usual diet and physical activity while avoiding additional probiotic, prebiotic, or polyphenol-rich supplements throughout the study. Participants will attend 4 in-person study visits at King's College London. At baseline, after 4 weeks, after 8 weeks (washout period) and after 12 weeks. Each study visit will take approximately 1 hour. On the day before each study visit, participants will be asked to self-collect their saliva, 24-h urine and stool samples at home, as well as finish a set of online questionnaires, and be fasted for 12 hours prior to their study visit. Self-collection procedure of participants at home one day before study visits: 1. Collect a total of 6 saliva samples throughout the day to measure cortisol levels and fill the saliva collection booklet. 2. Collect a 24 h urine sample, starting in the morning after the first void urine, and finishing the next day collecting the first urine of the day (morning of the study visit day). 3. Collect a small stool sample throughout the day for gut microbiome analysis. 4. Fill the below online questionnaires: 1. Positive and Negative Affect Schedule (PANAS-SF) questionnaire 2. Hospital Anxiety and Depression Scale (HADS) 3. Menopause Rating Scale (MRS) 4. Cognitive Failure Questionnaire (CFQ) 5. Perceived Stress Scale (PSS) 6. World Health Organisation Quality of Life assessment instrument (EF-WHOQOL-100) 5. Weekly questionnaire, 4 questionnaires per visit: 1. International Physical Activity Questionnaire (IPAQ) 2. Pittsburgh Sleep Quality Index (PSQI) 3. Online 24 h dietary recall (Intake 24) 4. 24h picture log of meals (OPIS) 5. Gastrointestinal Symptom Rating Scale (GSRS) 6. Menopause Rating Scale (MRS) 6. Fill the below paper questionnaires: 1. Food-Frequency Questionnaire - EPIC (only for visit 2) 2. Food-Frequency Questionnaire - KCL polyphenol (only for visit 4) On the morning of each study visit day, participants will bring their self-collected saliva, urine, and stool samples. Any Adverse events will be discussed and recorded. Any concomitant medication will be checked by the researchers that may impact on the eligibility criteria and the early completion of the study. Self-collected samples and completed online questionnaires will be checked. Blood pressure, heart rate and anthropometric measurements will be performed, waist-hip circumference will be measured, and fasting blood samples will be collected. On Visit 1 (baseline), either intervention snack or a calorie-matched placebo snack will be provided to participants, with the amount should be enough for the 4-week study period. On Visit 3 (after 8 weeks), the crossover snacks will be provided to participants. At the end of visit 1, 2 and 3, new self-collection kits and a link of online questionnaires will be distributed to participants to be used for next study visit.