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RECRUITING

NCT07599930

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

Sponsor: King's College London

View on ClinicalTrials.gov

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?

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

Key Details

Gender

FEMALE

Age Range

40 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-24

Completion Date

2026-12

Last Updated

2026-05-20

Healthy Volunteers

Yes

Conditions

Perimenopause Perimenopause-Related Depression Mood Sleep Quality of Life Gut -Microbiota

Interventions

DIETARY_SUPPLEMENT

Functional Snacks

A type of phytochemical and fibre rich snack that created and produced by TulaCode called Cinnamon Granola Bark (50 g per pouch). The snack contains the following ingredients: Amaranth, coconut flakes, chia seeds, pumpkin seeds, sunflower seeds, pecans, brazil nuts, almonds, dates, banana, cold pressed extra virgin olive oil, 100% cocoa mass, cocoa butter, chicory root fibre, cinnamon, cloves, nutmeg, ginger, ground vanilla pod, natural Bourbon vanilla flavouring, salt

OTHER

Placebo Snacks

A type of calorie-matched commercially available chocolate snack, Mini Cornflake Cluster Bites (50 g per pouch). The snack contains the following ingredients: Milk chocolate (60%) (sugar, cocoa butter, cocoa mass, skimmed milk powder, milk fat, lactose (milk), emulsifier (soya lecithin)), corn flakes (40%) (maize, sugar, salt, barley malt extract, dextrose, niacin, iron, vitamin B6, riboflavin, vitamin B1, folic acid, vitamin B12)

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * People who do not have any intolerances or allergies to the following: * Any kinds of nuts including tree nuts, peanuts, hazelnuts and coconuts * Chia seeds * Pumpkin seeds * Sunflower seeds * Dates * Gluten * Dairy * Oats * Barley * Soya * People who smoke or vape or have smoked or vaped in the last 2 years * People who consume more than 21 drinks a week or have a history of excess alcohol intake * People with comorbid conditions that may limit participation in the study, such as a history of an acute cardiovascular event, including coronary artery disease, previous myocardial infarction (heart attack), stroke, peripheral artery disease, diabetes mellitus, chronic kidney disease, metabolic syndrome, malignancies, cardiac arrhythmia, renal failure, cardiac failure, uncontrolled hypertension, cancer or major psychiatric or cognitive problems * People receiving drug treatment for lipid metabolisms (e.g., statins) * People with a history of long-term use of medicines known to influence glucose metabolism (e.g., corticosteroids) or aspirin * People taking antihypertensive drugs * People who take antibiotics or bacterial agents (Probiotics) within 1 month * People who take vitamin/dietary supplements within 1 month * Pregnant women, women ready for pregnancy, and nursing mothers * cardiac arrhythmia * renal failure * heart failure (NYHA II-IV) * diabetes mellitus * Malignant disease * People who have participated in a biomedical study within the past 3 months * Women who require hormone replacement therapy during the development of the protocol.

Locations (1)

Metabolic Research Unit (KCL, Waterloo Campus)

London, London, United Kingdom