Study of a New Phytochemical and Fibre-Rich Snack on Perimenopausal Symptoms and Well-being in Women Aged 40 to 55

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.

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