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

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

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?

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Sleep; Mood; Perimenopause; Gut -Microbiota; Perimenopause-Related Depression
• Intervention / Treatment: Dietary supplement: Functional Snacks; Other: Placebo Snacks

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Rodriguez-Mateos, PhD; Phone Number: 84349 +44 (0)20 7848 4349; Email: ana.rodriguez-mateos@kcl.ac.uk
• Study Contact Backup: Name: Zicheng Zhang, PhD; Phone Number: 80313 +44 (0)20 7848 0313; Email: swap@kcl.ac.uk

Study Locations

• United Kingdom
  • London
    • London, London, United Kingdom, SE1 9NH
      • Recruiting
      • Metabolic Research Unit (KCL, Waterloo Campus)
      • Contact: Zicheng Zhang, PhD; Phone Number: 80313 +442078480313; Email: swap@kcl.ac.uk
      • Contact: Nur Kamarunzaman, PhD; Phone Number: 84162 +44 (0)20 7848 4162; Email: swap@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: functional snacks then placebo snacks; 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; 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)
Experimental: placebo snacks then functional snacks; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in subjective (perceived) stress level of perimenopausal women	The subjective stress level of perimenopausal women are assessed using the Perceived Stress Scale (PSS) questionnaire. The scale consists in 10 items rated on a 5-point Likert scale.	Baseline & 4 weeks
Changes in affect in perimenopausal women	To assess the affect of perimenopausal women, using the Positive and Negative Affect Schedule (PANAS-SF) questionnaire, consisting of 20 items rated from 1 (very slightly or not at all) to 5 (extremely).	Baseline & 4 weeks
Changes in female sex hormone levels of perimenopausal women	To assess the female sex hormone levels of perimenopausal women, measured several esterone levels in blood samples using the randox clinical biochemistry analyser.	Baseline & 4 weeks
Changes in cognitive function of perimenopausal women	To assess cognitive function of perimenopausal womenm using Cognitive Failures questionnaire (CFQ). The questionnaire consists of 25 questions rated on a 5-point Likert scale from 0 ("Never") to 4 ("Very often").	Baseline & 4 weeks
Changes in mental health and wellbeing metabolites level of perimenopausal women	To assess the metabolites related to mental health and wellbeing of perimenopausal women, measured a pack of metabolites/compounds including gut-brain axis metabolites, inflammatory markers, short-chain fatty acid, in plasma samples using Randox clinical biochemistry analyser and LC-MS.	Baseline & 4 weeks
Habitual diet of perimenopausal women	Habitual diet is assessed via the food frequency questionnaire (FFQ), items ranging from "never" to "multiple times a day"-they consumed specific food and beverage items from a predefined list	Baseline only
Gut microbiome of perimenopausal women	To investigate the role of the gut microbiome on the perimenopause symptoms. Gut microbiome diversity and composition will be analysed using 16s RNA sequencing technique as a pack.	Baseline & 4 weeks
Changes in hormonal stress levels in perimenopausal women	Stress measured as the cortisol level changes in saliva samples by LC-MS, including the cortisol levels at 0 min, 15 min, 30 min and 60 min after wakening and 12 pm and 8 pm on the day.	Baseline & 4 weeks
Changes in mood in perimenopausal women	To assess the overall changes in mood, using the Hospital Anxiety and Depression Scale (HADS), consist of 14 items rated on a 0-21 scale, with a higher score indicates a severe symptom.	Baseline & 4 weeks
Changes in sleep quality in perimenopausal women	Sleep quality changes measured using Pittsburgh Sleep Quality Index (PSQI) questionnaire, consist of 19 items rated on a 0-3 scale with higher scores indicating poorer sleep quality.	Weekly from baseline to 4 weeks
Changes in physical activity level in perimenopausal women	Changes in physical activity measured using the International Physical Activity questionnaire (IPAQ), producing a total activity score expressed in metabolic equivalent minutes per week (MET-min/week).	Weekly from baseline to 4 weeks
Changes in quality of life in perimenopausal women	Changes in quality of life measured using the World Health Organisation Quality of Life Assessment Instrument (EF-WHOQOL-100), a 100 item questionnaire with responses rated on a 1-5 Likert scale	Baseline & 4 weeks
Changes in gastrointestinal symptoms of perimenopausal women	Changes in the gastrointestinal function measured using Gastrointestinal Symptom Rating Scale (GSRS) questionnaire, consisting of 15 items rated from 1 (no discomfort) to 7 (very severe discomfort).	Weekly from baseline to 4 weeks
Changes in weight of perimenopausal women	Weight will be measured in kilograms using a body composition analyser (Tanita BC-418 MA)	Baseline & 4 weeks
Height of perimenopausal women	Height in centimeters will be measured using a stadiometer	Baseline
Changes in BMI of perimenopausal women	Changes in BMI will be measured by weighing participants using the body composition analyser (Tanita BC-418 MA) and calculating BMI from participant height and weight	Baseline & 4 weeks
Changes in hip-waist circumference of perimenopausal women	Hip and waist circumference will be measured in centimeters using a measuring tape	Baseline & 4 weeks
Changes in blood pressure of perimenopausal women	Blood pressure will be measured using an electric sphygmomanometer blood pressure monitor in millimeters of mercury (mmHg).	Baseline & 4 weeks
Heart rate of perimenopausal women	Heart rate will be measured in beats per minute using an electric sphygmomanometer blood pressure monitor	Baseline & 4 weeks
Dietary polyphenol intake of perimenopausal women	Polyphenol intake measured via the Food-Frequency Questionnaire - Polyphenol. Food items are rated from "Never" to "More than 6 times per day".	Baseline
Weekly diet of perimenopausal women	Weekly diet using Intake24, an online 24-hour dietary recall system that records all foods and drinks consumed during the previous day. It uses portion-size images and structured prompts to improve accuracy and reduce under-reporting.	Weekly from baseline to week 4
Weekly diet of perimenopausal women	Weekly diet will be measured using OPIS, a mobile application using artificial intelligence to estimate the nutrients and components of meals. Participants take a picture of their meals for 24 hours in the application and AI breaks down the make-up of the food.	Weekly from baseline to week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma and Urinary metabolites of (poly)phenols of perimenopausal women	In total more than 160 phenolic compounds and phase 2 metabolites will be measured in plasma and urine samples by LC-MS.	Baseline and 4 weeks

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Tulā Code Ltd
• Investigators: Principal Investigator: Ana Rodriguez-Mateos, PhD, King's College London

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: sleep; quality of life; gut; mood; fibre; phytochemical
• Other Study ID Numbers: SWAP Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No