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RecruitingNAINTERVENTIONAL

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

Researchers are investigating if a new snack, rich in plant compounds and fibre, can reduce common perimenopause symptoms in women aged 40-55 who are not taking hormone replacement therapy. Perimenopause is the time leading up to menopause, often causing symptoms like hot flushes, night sweats, changed moods, and sleep difficulties. This study wants to find out if eating this snack daily can improve these symptoms, as well as overall mood, stress, and sleep. They also hope to understand if the snack works by improving the balance of 'good' bacteria in the gut. Participants will eat either the special snack or a simple oat bar, switching after a break, so everyone tries both.

At a glance

Status
Recruiting
Phase
NA
Sponsor
King's College London
Enrolment target
20
Start
24 Apr 2026
Estimated completion
01 Dec 2026

What is this study about?

This study is designed to explore whether a specially developed snack can help women who are experiencing perimenopause. Perimenopause is the natural transition period that happens before menopause, and it can bring about various changes and symptoms like hot flushes, night sweats, changes in mood, and difficulties with sleep. This research specifically focuses on women between 40 and 55 years old who are not currently using hormone replacement therapy, as this allows the researchers to clearly see the snack's effects.

The main idea behind this study is that a snack rich in natural plant compounds (phytochemicals) and fibre might be able to improve these perimenopausal symptoms. The researchers also want to see if the snack can boost overall well-being, including mood, stress levels, anxiety, and sleep quality. They are particularly interested in whether any positive changes are linked to how the snack affects the 'good' bacteria in the gut, which is known to play a role in various bodily functions, including mood and hormone balance.

To get reliable results, the study will compare this special snack to a standard oat bar that doesn't have these extra plant compounds or fibre. Both you and the study team won't know which snack you're eating at any given time (this is called 'double-blind'), ensuring that expectations don't influence the results. You'll switch between the two snacks after a break, which allows researchers to compare the effects of both on the same person. This careful approach helps them determine if the special snack truly makes a difference.

Key takeaways

  • Study for women aged 40-55 with perimenopause symptoms.
  • Investigating a special snack for symptom relief and well-being.
  • Compares special snack to a plain oat bar.
  • Involves home tasks and four short visits to King's College London.
  • Focuses on gut health and its link to perimenopause symptoms.

Who may be eligible?

This study is looking for women aged between 40 and 55 who are going through perimenopause and experiencing symptoms. To check if you qualify, you'll need to score 14 or higher on a special questionnaire about menopause symptoms. You must also have a mobile phone and be able to speak and read English.

There are several reasons why you might not be able to join the study. These include if you already eat a very high amount of fibre, fruit, or vegetables, or drink a lot of coffee or tea daily. Certain allergies or intolerances to common food ingredients like nuts, seeds, gluten, dairy, oats, barley, or soya would also mean you can't take part. If you smoke or vape (or have in the last two years), drink a lot of alcohol, or have certain serious health conditions like diabetes, heart problems, kidney issues, or cancer, this study wouldn't be suitable for you.

Also, if you're taking specific medications like statins (for cholesterol), certain medicines for blood pressure, or long-term medication for glucose management, you wouldn't be eligible. If you've recently taken antibiotics, probiotics, or many vitamin/dietary supplements (within the last month), or if you are pregnant, planning to get pregnant, or breastfeeding, you won't be able to join. Finally, if you've already taken part in another medical study in the last three months, or if you need hormone replacement therapy, this study isn't for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you a woman aged between 40 and 55?
  2. Do you experience perimenopause symptoms like hot flushes or mood changes?
  3. Are you NOT taking hormone replacement therapy?
  4. Do you NOT have serious health conditions like diabetes or heart problems?
  5. Are you free from major food allergies to common nuts, seeds, gluten, dairy, or oats?
  6. Have you NOT taken antibiotics, probiotics, or many vitamin supplements recently?
Answer every question to see your result.

What does participation involve?

If you join this study, you will eat a snack twice a day for a total of eight weeks. For four weeks, you'll eat either the special snack or a plain oat bar. Then, after a four-week break (called a 'washout' period), you'll switch to the other snack for another four weeks. While taking part, you'll be asked to keep your usual diet and exercise routine and avoid taking any extra probiotics, prebiotics, or supplements rich in plant compounds.

You will need to attend four in-person visits at King's College London. Each visit will take about an hour and will happen at the start of the study, after four weeks, after eight weeks (at the end of your break), and after twelve weeks (at the end of your second snack period).

On the day before each of these visits, you'll have some tasks to complete at home. This includes collecting six saliva samples throughout the day, collecting all your urine over a 24-hour period, and taking a small stool sample. You'll also need to fill out some online questionnaires about your mood, anxiety, and depression. On the morning of your visit, you'll need to have fasted for 12 hours (meaning no food or drink other than water) before you come in.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as a possible improvement in your perimenopause symptoms, mood, and sleep, should the special snack prove effective. You'll also be contributing valuable information to help researchers understand more about perimenopause and diet. As with any study, there could be minor inconveniences like collecting samples and attending appointments. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Metabolic Research Unit (KCL, Waterloo Campus)
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is perimenopause?

Perimenopause is the time when your body is naturally transitioning into menopause, usually in your 40s or 50s. It can come with symptoms like hot flushes, mood changes, and trouble sleeping.

Will I know if I'm eating the special snack or the plain one?

No, neither you nor the research team will know which snack you are eating at any time. This is standard in studies to ensure fair results.

How often do I need to visit King's College London?

You'll need to attend four short appointments at King's College London over the 12-week study period.

Do I need to change my diet or exercise routines?

You should aim to keep your normal diet and exercise routines. However, you'll need to avoid specific supplements like probiotics or certain high-fibre products during the study.

What kind of samples do I need to collect?

You'll be asked to collect saliva, urine, and a small stool sample at home the day before each of your study visits.

How to find out more

Ana Rodriguez-Mateos, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Impact of a Novel Functional Snack on Perimenopausal Symptom…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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