Not yet recruitingNAINTERVENTIONAL

Nutritional Supplementation on Physiological and Metabolic Markers in Females

This study aims to discover if a 12-week nutritional supplement can help women between 38 and 55 years old who are experiencing changes related to perimenopause, the time leading up to menopause. Researchers are keen to understand if this supplement, containing ingredients like myo-inositol and cinnamon, makes a difference to body composition, such as body mass index and body fat. We also want to see if it impacts small molecules in the blood and urine, menopause symptoms, and physical abilities like grip strength. Participants will receive either the supplement or a placebo (a look-alike pill with no active ingredients) to help researchers compare the effects accurately.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University of Southampton

Enrolment target

Start

01 Jun 2026

Estimated completion

01 Dec 2026

Perimenopausal Women Body Composition Changes

What is this study about?

Many women between the ages of 38 and 55 start to experience changes as they approach menopause. This time, known as perimenopause, can bring about various shifts in the body. One common change is in body composition, which means how much fat and muscle you have in your body. It's often noticed that weight might increase, especially around the middle, and muscle mass could decrease. These changes are mainly due to natural shifts in hormones, particularly a decrease in oestrogen, which happens as we get older.

These body changes can sometimes increase the risk of conditions like heart disease and diabetes. While there are different ways to manage these shifts, including hormone treatments, researchers are also looking into natural options like nutritional supplements. This study focuses on a specific supplement that includes ingredients like myo-inositol, berberine, cinnamon, and chromium, which have been suggested to have some promising health benefits.

The main purpose of this study is to see if taking this nutritional supplement for 12 weeks can help improve body composition in women aged 38-55. We also want to explore if it can help with common menopause-related symptoms and improve physical strength. By comparing the supplement to a placebo (a dummy pill), we can get a clearer idea of whether the supplement itself is causing any positive effects.

Key takeaways

This study investigates a nutritional supplement for women aged 38-55 experiencing perimenopause.
It aims to understand effects on body composition, menopause symptoms, and physical performance.
Participants will take either the supplement or a placebo for 12 weeks.
Participation involves two hospital visits, blood/urine samples, and various measurements.
The study takes place at Southampton General Hospital.
Your willingness to participate and stop other supplements is key if you meet the criteria.

Who may be eligible?

This study is looking for women who are between 38 and 55 years old. You should have been assigned female at birth and be experiencing irregular periods, or at least one recent menopause-related symptom like hot flushes, mood swings, sleep problems, bloating, or weight gain. It's important that you are willing to avoid taking other food supplements during the study and can provide your written permission to take part.

However, there are some reasons why you might not be able to join. For instance, if you have diabetes, a very low body mass index (below 18.5), are pregnant or trying to get pregnant, or have had certain types of cancer or a total hysterectomy recently. Also, if you're allergic to any of the ingredients in the supplement (cinnamon, chromium, berberine, myo-inositol), have certain autoimmune diseases, a diagnosed low blood sugar condition, or are currently in another research study, you wouldn't be able to participate.

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.

Are you female and aged between 38 and 55 years?
Are you experiencing irregular periods or recent menopause symptoms (like hot flushes, mood swings, or weight gain)?
Are you able to avoid taking other food supplements during the study?
Do you have any conditions like diabetes, active cancer, or severe allergies to cinnamon, chromium, berberine, or myo-inositol?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first need to read and sign a consent form, which explains everything in detail. Throughout the 12-week study, you will visit the clinical research facility at Southampton General Hospital two times. Before each visit, you'll need to fast, and at these appointments, you'll provide blood and urine samples. We will also take various measurements, such as your waist and hip size, and test your grip and leg strength, along with detailed body composition measurements.

You'll also fill out questionnaires about your general health, any menopause symptoms you're experiencing, your alcohol intake, how active you are, and your typical diet. For the first 10 days, you'll take one capsule three times a day with meals. From day 11 until day 84, this will increase to three capsules, three times a day with meals. You'll also be asked to keep a daily diary to record every time you take the supplement. The total duration of your active participation, including the follow-up period, is 12 weeks.

Potential risks and benefits

Participating in this study might offer some potential benefits, as the nutritional supplement being tested may help with body composition and menopause-related symptoms. However, it's also possible that you may not experience any direct benefit. As with any clinical study, there are potential risks, mainly associated with the blood draws and the possibility of mild side effects from the supplement, though these are expected to be minimal. All procedures will be carried out by trained professionals. Remember, your participation is completely voluntary, and you have the right to withdraw from 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.

NIHR Southampton Clinical Research Facility
Verified postcode
Southampton, United Kingdom

Common questions

What is perimenopause?

Perimenopause is the time leading up to menopause when your body starts to change and prepare for the end of your reproductive years. It's when you might start noticing symptoms like irregular periods, hot flushes, or mood changes.

What is a placebo?

A placebo is a substance that looks exactly like the actual treatment but doesn't contain any active ingredients. It helps researchers understand if the real treatment is having an effect or if changes are due to other factors.

How many visits will I need to make?

You will need to attend two visits to the clinical research facility at Southampton General Hospital over the 12-week study period.

Will I know if I'm taking the supplement or the placebo?

No, you won't know whether you're receiving the active supplement or the placebo during the study. This helps ensure the results are unbiased and accurate.

What kind of measurements will be taken?

Measurements will include your waist and hip size, body strength tests (like grip and leg strength), and detailed body composition assessments, along with blood and urine samples.

How to find out more

Colleen S Deane, PhD

c.s.deane@soton.ac.uk +44 2381208664 Official trial record

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