Novel functional snack and perimenopause: does a fibre- and phytochemical-rich bite help symptoms?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study uses a double-blind, randomized, placebo-controlled crossover design to compare a functional snack with a low-fiber, low-polyphenol placebo over two 4-week periods, separated by a 4-week washout. Participants will consume the assigned snack twice daily while maintaining usual diet and activity and avoiding other probiotic or polyphenol-rich supplements. Outcomes include menopausal symptoms, mood, stress, sleep, cognition, and quality of life, with gut microbiota as a potential mechanism. In-person visits occur at 0, 4, 8, and 12 weeks, with home sample collection preceding visits.

Why it matters

Who can join: the full rules

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.

Where it's running

• Metabolic Research Unit (KCL, Waterloo Campus)
  London, London, United Kingdom Recruiting

Study contacts

• Principal investigator: Ana Rodriguez-Mateos, PhD — King's College London
• Study coordinator: Ana Rodriguez-Mateos, PhD
• Email: ana.rodriguez-mateos@kcl.ac.uk
• Phone: +44 (0)20 7848 4349

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Probiotic Intake to See If It Helps Perimenopausal Women Think and Feel Better

  We’re testing whether a multi-strain probiotic can improve emotional processing and cognitive function in perimenopausal women who have mood or cognitive concerns.

  Recruiting University of Oxford · Oxford, England · NCT07590999

• Understanding immune clues to depression in perimenopause

  This study tests whether immune and epigenetic changes during perimenopause help explain why some women develop depression.

  Recruiting at 3 sites Van Andel Research Institute · Grand Rapids, Michigan and 3 other locations · NCT07910552

• Hop extract vs soy isoflavone for menopausal symptoms

  This study tests whether a full-spectrum hop extract helps reduce menopausal mood symptoms better than soy isoflavones in peri- and postmenopausal women.

  Recruiting Menoclinica by Palacios · Madrid, Madrid · NCT07904390

• Plant extract supplement for menopausal symptoms in women around menopause

  A plant-extract dietary supplement is being tested to see if it helps hot flashes and related symptoms in women aged 42–60 who are nearing or just past menopause, compared with a placebo.

  Recruiting University of Alicante · Elche, Alicante · NCT07863973

• Lifestyle changes to ease menopausal symptoms, sleep problems, and anxiety

  Researchers are testing whether a structured lifestyle education program helps perimenopausal and postmenopausal women see fewer menopausal symptoms, better sleep, and less anxiety compared to usual care.

  Recruiting Konya Beyhekim Training and Research Hospital · Konya, Konya · NCT07860645

• Overnight Temperature Regulation to Test Gut Health, Inflammation, and Circadian Rhythms

  This study tests whether two weeks of using the Eight Sleep Pod at night can improve gut bacteria balance, lower inflammation, and strengthen daily temperature and blood pressure rhythms in postmenopausal women and age-matched men with poor sleep.

  Recruiting Eight Sleep Inc. · Newton Center, Massachusetts · NCT07848594

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.