Not yet recruitingNAINTERVENTIONAL

The BALANCE Study - Improving Glucose Control Through Prebiotic Gut Health Drink in Postmenopausal Women

The BALANCE Study is investigating if a special gut health drink, called ió everyday, can help postmenopausal women with prediabetes improve their blood sugar. After menopause, changes in hormones can affect a woman's metabolism, sometimes leading to an increased risk of type 2 diabetes. This drink contains a prebiotic called inulin, which is thought to encourage healthy gut bacteria. Researchers believe that by improving gut health, this drink might help the body control blood sugar better. The study aims to see if daily use of ió everyday for four weeks makes a difference compared to a dummy drink, looking at blood sugar and other health markers.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University of Roehampton

Enrolment target

Start

10 Jun 2026

Estimated completion

15 May 2027

Menopause

What is this study about?

When women go through menopause, their bodies change quite a bit, partly due to a drop in hormones like oestrogen. These changes can sometimes make it harder for the body to manage blood sugar, which can increase the risk of developing type 2 diabetes. There's growing evidence that the bacteria living in our gut – often called the gut microbiome – play a really important role in how our body handles sugar and its overall metabolism. It's thought that the hormonal shifts during menopause might also affect these gut bacteria.

This study is looking at a specific type of helpful fibre called a prebiotic. Prebiotics act like food for good bacteria in your gut, helping them grow and thrive. The researchers think that boosting these good bacteria might help improve how the body controls blood sugar, especially in women who have gone through menopause and are at risk of type 2 diabetes (a condition called prediabetes). Previous studies have shown that a prebiotic called inulin, which is in the ió everyday drink, can help with blood sugar and weight in other groups of people, but it hasn't been specifically tested in postmenopausal women with prediabetes before.

The main goal of The BALANCE Study is to see if drinking ió everyday daily for four weeks improves blood sugar control in these women. They'll also be looking at other health markers and how changes in gut bacteria might be connected to any improvements seen. The hope is that this drink could offer a simple, natural way to help manage blood sugar after menopause.

Key takeaways

Study for postmenopausal women (45-60) with prediabetes.
Investigates a prebiotic gut health drink (ió everyday).
Aims to improve blood sugar control.
Participation involves taking a daily drink for 4 weeks.
Compares the drink to a dummy version (placebo).
Requires providing stool samples.

Who may be eligible?

This study is looking for women aged between 45 and 60 who have gone through menopause (meaning they haven't had a period for at least 12 months). You should be generally healthy and live in the UK. Importantly, you need to have a Body Mass Index (BMI) of 25 or higher and show some signs of prediabetes, which means your blood sugar levels are higher than normal but not yet high enough for a diagnosis of type 2 diabetes.

There are also some things that would mean you can't join. For example, if you have serious stomach or bowel problems, a weakened immune system, or other major long-term illnesses. You also shouldn't have taken antibiotics recently (within the last 2-3 months) or regularly use other probiotic or prebiotic supplements. If you're on medications or special diets that strongly affect your gut bacteria, or if you've recently lost a lot of weight on purpose, you also wouldn't be able to take part.

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, aged 45-60?
Have you not had a period for at least 12 months (postmenopausal)?
Do you have a BMI of 25 or more, and signs of prediabetes (higher than normal blood sugar)?
Are you generally healthy with no major stomach/bowel issues or serious long-term illnesses?
Have you not taken antibiotics in the last 2-3 months or regularly use other gut supplements?
Are you willing to take a daily drink for 4 weeks and provide stool samples?

Answer every question to see your result.

What does participation involve?

If you take part in The BALANCE Study, your involvement will last for 4 weeks. You'll be randomly assigned to one of two groups: one group will receive the ió everyday gut health drink, and the other will receive a dummy drink (a placebo) that looks and tastes similar but doesn't contain the active ingredient. For the first week, you'll drink one sachet daily with a meal, and then for the following three weeks, you'll drink two sachets daily with meals. You'll be asked to provide stool (poop) samples at specific times during the study. The study involves a few visits for assessments, but the overall duration of active participation is 4 weeks.

Potential risks and benefits

Potential benefits of taking part in this study include gaining a better understanding of your own health and potentially improving your blood sugar control. You'd also be contributing important information that could help other women navigate health changes after menopause. As with any study, there could be some minor risks, such as mild stomach upset from the drinks or the inconvenience of providing samples. You are free 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.

Health Sciences Research Centre, Life Sciences Department, University of Roehampton
Verified postcode
London, United Kingdom

Common questions

What is prediabetes?

Prediabetes means your blood sugar levels are higher than normal but not high enough yet to be diagnosed with type 2 diabetes. It's a warning sign that you're at risk.

What is a prebiotic?

Prebiotics are special kinds of fibre that act as food for the good bacteria in your gut, helping them grow and stay healthy.

Will I know if I'm getting the active drink or the placebo?

No, this is a 'blinded' study, meaning neither you nor the researchers will know which drink you're getting until after the study is over. This helps ensure fair results.

How long will I need to take the drink for?

You will take the assigned drink daily for a total of four weeks.

Do I need to change my diet or exercise routines?

You need to maintain your usual diet and exercise routines throughout the study. Significant changes during this time could affect the results.

How to find out more

ADELE COSTABILE, Prof

adele.costabile@roehampton.ac.uk 02083923571 Official trial record

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