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

NCT07599930 | Recruiting

• 1 other identifier: SWAP Study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

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

Keywords

phytochemical; fibre; mood; sleep; quality of life; gut

Outcome Measures

Primary Outcomes (1)

• Changes in menopause rating scale (MRS) of perimenopausal women

  To assess menopause-related symptoms of perimenopausal women, using the menopause rating scale (MRS). The scale consists in 11 items ranging from 0 (none) to 4 (very severe).

  Baseline & 4 weeks

Secondary Outcomes (22)

• Changes in subjective (perceived) stress level of perimenopausal women

  Baseline & 4 weeks

• Changes in affect in perimenopausal women

  Baseline & 4 weeks

• Changes in female sex hormone levels of perimenopausal women

  Baseline & 4 weeks

• Changes in cognitive function of perimenopausal women

  Baseline & 4 weeks

• Changes in mental health and wellbeing metabolites level of perimenopausal women

  Baseline & 4 weeks

Other Outcomes (1)

• Plasma and Urinary metabolites of (poly)phenols of perimenopausal women

  Baseline and 4 weeks

Study Arms (2)

functional snacks then placebo snacks

EXPERIMENTAL

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

Dietary Supplement: Functional Snacks; Other: Placebo Snacks

placebo snacks then functional snacks

EXPERIMENTAL

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

Dietary Supplement: Functional Snacks; Other: Placebo Snacks

Interventions

Functional Snacks DIETARY_SUPPLEMENT

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

functional snacks then placebo snacks; placebo snacks then functional snacks

Placebo Snacks OTHER

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)

functional snacks then placebo snacks; placebo snacks then functional snacks

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Tulā Code Ltd: collaborator

Study Sites (1)

Metabolic Research Unit (KCL, Waterloo Campus)

London, London, SE1 9NH, United Kingdom

RECRUITING

Study Officials

• Ana Rodriguez-Mateos, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Rodriguez-Mateos, PhD

CONTACT

+44 (0)20 7848 4349; ana.rodriguez-mateos@kcl.ac.uk

Zicheng Zhang, PhD

CONTACT

+44 (0)20 7848 0313; swap@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 20, 2026
• Study Start: April 24, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)