MenopauseBALANCENCT07565675
The BALANCE Study - Improving Glucose Control Through Prebiotic Gut Health Drink in Postmenopausal Women
A study testing ió everyday (a prebiotic- enriched gut health drink containing inulin) in people with Menopause, run by University of Roehampton at 1 site in United Kingdom.
Trial summary
The menopausal transition is associated with a decline in oestrogen levels, contributing to adverse metabolic changes including increased central adiposity, systemic inflammation, and insulin resistance. These changes are linked to a higher risk of developing type 2 diabetes in postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- ió everyday (a prebiotic- enriched gut health drink containing inulin)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jun 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, aged 45-60 years
- Post-menopausal (no menstrual period for ≥12 months)
- No serious long-term medical conditions
- Living in the UK
- Able to read English and provide electronic informed consent
- Willing and able to comply with study procedures, including dietary intervention and sample collection
Show all 14Show fewer
- Willing to provide stool samples at specified time points
- BMI ≥25 kg/m² with one of the following:
- Impaired glucose tolerance (7.8-11.0 mmol/L at 2-hour OGTT), or
- Impaired fasting glucose (5.6-6.9 mmol/L), or
- HbA1c 5.7%-6.4%
- No intentional dieting within the past month
- No >5% body weight loss in the past year
- No changes in physical activity in the past 2-4 weeks and no intention to change during the study
Who cannot join
- Significant gastrointestinal disease (e.g., inflammatory bowel disease, coeliac disease) or other major medical conditions affecting gut microbiota or study safety
- Immunocompromised status or other serious chronic illness
- Use of antibiotics within the past 2-3 months
- Regular use of probiotics or prebiotics within the past 4 weeks
- Use of medications or special diets that significantly affect gut microbiota (e.g., chronic laxatives, immunosuppressants)
- Known allergies or intolerances to components of the prebiotic formulation
- Participation in another interventional clinical trial within the past 3 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, SW15 4JD
About this study
Official title: Improving Glucose Control Through Prebiotic Gut Health Drink in Postmenopausal Women
The menopausal transition is associated with a decline in oestrogen levels, contributing to adverse metabolic changes including increased central adiposity, systemic inflammation, and insulin resistance. These changes are linked to a higher risk of developing type 2 diabetes in postmenopausal women.
Recent evidence suggests that the gut microbiota plays an important role in metabolic regulation and glucose homeostasis. Menopause-related hormonal changes may alter the composition and function of the gut microbiome, with downstream effects on insulin sensitivity. Additionally, certain gut bacteria (i.e., Bifidobacterium species) regulate circulating oestrogen via β-glucuronidase activity, highlighting a potential interaction between microbial composition and hormonal balance. Observational findings support associations between menopausal stage, gut microbiota alterations, and insulin homeostasis.
Read more
Prebiotics are non-digestible compounds that selectively stimulate beneficial gut bacteria and may improve metabolic outcomes. Modulation of the gut microbiota through prebiotic supplementation represents a promising non-pharmacological strategy to improve glucose control. Multiple studies have demonstrated that inulin (a common prebiotic) can improve glucose regulation and aid weight loss in individuals with obesity, prediabetes, or type 2 diabetes. However, to date, no randomised controlled trials have specifically investigated prebiotic supplementation in postmenopausal women with prediabetes using dynamic measures such as the Oral Glucose Tolerance Test (OGTT).
The present study aims to investigate the effect of daily consumption of an inulin-containing prebiotic gut health drink (ió everyday) on glucose control in postmenopausal women with prediabetes. The primary objective is to determine whether the intervention improves glycaemic control. Secondary objectives include exploration of changes in metabolic markers and assessment of the role of the gut microbiota in mediating these effects.
It is hypothesised that consumption of ió everyday will improve glucose control in prediabetic women who have recently undergone menopause. This hypothesis is supported by evidence demonstrating that inulin and soluble corn fibre can improve glucose regulation and support weight management in individuals with obesity, prediabetes, or type 2 diabetes, as well as findings from a previous study (Ethics Ref ID: LSC 23/383), which demonstrated that one month of ió everyday consumption significantly reduced fasting glucose, with a trend towards weight reduction and no reported adverse effects.
Read the detailed description
This is a 4-week, randomised, placebo-controlled pilot trial investigating the effects of a gut ió everyday on glucose control in postmenopausal women with prediabetes. Participants will be allocated to either an intervention or placebo group. The intervention consists of ió everyday consumed daily for 4 weeks (one sachet daily in week 1, increasing to two sachets daily in weeks 2-4, taken with meals). The placebo group will receive matched sachets without inulin but equivalent in energy content. This is an investigator-initiated, randomised, placebo-controlled pilot study.
- Conditions
- Menopause
- Being tested
- ió everyday (a prebiotic- enriched gut health drink containing inulin), Placebo Comparator
- Keywords
- menopause, diabetes, obesity
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ió everyday (a prebiotic- enriched gut health drink containing inulin)Dietary supplement
Participants will consume the equivalent placebo comparator for 4 weeks. Each sachet contains 5 g inulin of maltodextrin. Participants will consume one sachet daily in week 1 to allow acclimatisation, increasing to two sachets daily in weeks 2-4. Sachets are diluted in 500 mL of water and consumed with lunch and dinner.
Placebo ComparatorDietary supplement
Participants will consume ió everyday for 4 weeks. Each sachet contains 4.5 g inulin and 6 g total fibre. Participants will consume one sachet daily in week 1 to allow acclimatisation, increasing to two sachets daily in weeks 2-4. Sachets are diluted in 500 mL of water and consumed with lunch and dinner.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement: Formulation 1 | Active comparator | Each sachet contains 4.5 g inulin and 6 g total fibre. Participants will consume one sachet daily in week 1 to allow acclimatisation, increasing to two sachets daily in weeks 2-4. Sachets are diluted in 500 mL of water and consumed with lunch and dinner. Receives: Dietary Supplement: ió everyday (a prebiotic- enriched gut health drink containing inulin) |
| Dietary Supplement: Formulation 2 | Placebo comparator | Calorie-matched comparator containing ~5 g maltodextrin Receives: Dietary Supplement: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Plasma Glucose
Change in fasting plasma glucose measured from venous blood samples.
Measured: Baseline and 4 weeks (end of intervention).
Secondary outcomes (6)
Anthropometric Measurements
Change in body fat percentage measured using standardised clinical methods.
Measured: Baseline and 4 weeks (end of intervention).
HbA1c (Glycated Haemoglobin)
Change in HbA1c as an exploratory marker of glycaemic control (interpretation is limited due to the short 4-week intervention duration).
Measured: Baseline and 4 weeks (end of intervention).
Inflammatory Markers
Change in circulating inflammatory markers associated with metabolic risk
Measured: Baseline and 4 weeks (end of intervention).
Gut Microbiota Composition
Changes in gut microbiota diversity and composition assessed via stool samples and 16S rRNA sequencing.
Measured: Baseline and 4 weeks (end of intervention).
Gastrointestinal Symptoms
Changes in self-reported gastrointestinal symptoms (score max 10 and less of 1) including stool frequency and consistency (Bristol Stool Scale), bloating, abdominal pain, and flatulence.
Measured: Baseline and 4 weeks (end of intervention).
Dietary Intake
Change in habitual dietary intake assessed using 4-day food records at baseline and after 4 weeks.
Measured: Baseline and 4 weeks (end of intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start10 Jun 2026
- Primary completion30 Jul 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 4-week, randomised, placebo-controlled pilot trial investigating the effects of a gut ió everyday on glucose control in postmenopausal women with prediabetes. Participants will be allocated to either an intervention or placebo group. The intervention consists of ió everyday consumed daily for 4 weeks (one sachet daily in week 1, increasing to two sachets daily in weeks 2-4, taken with meals). The placebo group will receive matched sachets without inulin but equivalent in energy content. This is an investigator-initiated, randomised, placebo-controlled pilot study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ADELE COSTABILE, University of Roehampton
- Investigators
- Adele Costabile, Prof, Study director, University of Roehampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565675
- Sponsor's protocol ID
- LSC-2025-14
- Other IDs
- Patterson-BIV-Sept25
- Acronym
- BALANCE
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Glucose Control Through Prebiotic Gut Health Drink in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07565675
- Acronym / sponsor ID
- BALANCE / LSC-2025-14
- Conditions
- Menopause
- Keywords
- menopause, diabetes, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The menopausal transition is associated with a decline in oestrogen levels, contributing to adverse metabolic changes including increased central adiposity, systemic inflammation, and insulin resistance. These changes are linked to a higher risk of developing type 2 diabetes in postmenopausal women.
Recent evidence suggests that the gut microbiota plays an important role in metabolic regulation and glucose homeostasis. Menopause-related hormonal changes may alter the composition and function of the gut microbiome, with downstream effects on insulin sensitivity. Additionally, certain gut bacteria (i.e., Bifidobacterium species) regulate circulating oestrogen via β-glucuronidase activity, highlighting a potential interaction between microbial composition and hormonal balance. Observational findings support associations between menopausal stage, gut microbiota alterations, and insulin homeostasis.
Prebiotics are non-digestible compounds that selectively stimulate beneficial gut bacteria and may improve metabolic outcomes. Modulation of the gut microbiota through prebiotic supplementation represents a promising non-pharmacological strategy to improve glucose control. Multiple studies have demonstrated that inulin (a common prebiotic) can improve glucose regulation and aid weight loss in individuals with obesity, prediabetes, or type 2 diabetes. However, to date, no randomised controlled trials have specifically investigated prebiotic supplementation in postmenopausal women with prediabetes using dynamic measures such as the Oral Glucose Tolerance Test (OGTT).
The present study aims to investigate the effect of daily consumption of an inulin-containing prebiotic gut health drink (ió everyday) on glucose control in postmenopausal women with prediabetes. The primary objective is to determine whether the intervention improves glycaemic control. Secondary objectives include exploration of changes in metabolic markers and assessment of the role of the gut microbiota in mediating these effects.
It is hypothesised that consumption of ió everyday will improve glucose control in prediabetic women who have recently undergone menopause. This hypothesis is supported by evidence demonstrating that inulin and soluble corn fibre can improve glucose regulation and support weight management in individuals with obesity, prediabetes, or type 2 diabetes, as well as findings from a previous study (Ethics Ref ID: LSC 23/383), which demonstrated that one month of ió everyday consumption significantly reduced fasting glucose, with a trend towards weight reduction and no reported adverse effects.
Detailed description
This is a 4-week, randomised, placebo-controlled pilot trial investigating the effects of a gut ió everyday on glucose control in postmenopausal women with prediabetes. Participants will be allocated to either an intervention or placebo group. The intervention consists of ió everyday consumed daily for 4 weeks (one sachet daily in week 1, increasing to two sachets daily in weeks 2-4, taken with meals). The placebo group will receive matched sachets without inulin but equivalent in energy content. This is an investigator-initiated, randomised, placebo-controlled pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a 4-week, randomised, placebo-controlled pilot trial investigating the effects of a gut ió everyday on glucose control in postmenopausal women with prediabetes. Participants will be allocated to either an intervention or placebo group. The intervention consists of ió everyday consumed daily for 4 weeks (one sachet daily in week 1, increasing to two sachets daily in weeks 2-4, taken with meals). The placebo group will receive matched sachets without inulin but equivalent in energy content. This is an investigator-initiated, randomised, placebo-controlled pilot study.
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement: Formulation 1 | Active comparator | Dietary Supplement: ió everyday (a prebiotic- enriched gut health drink containing inulin)Each sachet contains 4.5 g inulin and 6 g total fibre. Participants will consume one sachet daily in week 1 to allow acclimatisation, increasing to two sachets daily in weeks 2-4. Sachets are diluted in 500 mL of water and consumed with lunch and dinner. |
| Dietary Supplement: Formulation 2 | Placebo comparator | Dietary Supplement: Placebo ComparatorCalorie-matched comparator containing ~5 g maltodextrin |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Female, aged 45-60 years
- Post-menopausal (no menstrual period for ≥12 months)
- No serious long-term medical conditions
- Living in the UK
- Able to read English and provide electronic informed consent
Key exclusion criteria (7 listed)
- Significant gastrointestinal disease (e.g., inflammatory bowel disease, coeliac disease) or other major medical conditions affecting gut microbiota or study safety
- Immunocompromised status or other serious chronic illness
- Use of antibiotics within the past 2-3 months
- Regular use of probiotics or prebiotics within the past 4 weeks
- Use of medications or special diets that significantly affect gut microbiota (e.g., chronic laxatives, immunosuppressants)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ió everyday (a prebiotic- enriched gut health drink containing inulin)Participants will consume the equivalent placebo comparator for 4 weeks. Each sachet contains 5 g inulin of maltodextrin. Participants will consume one sachet daily in week 1 to allow acclimatisation, increasing to two sachets daily in weeks 2-4. Sachets are diluted in 500 mL of water and consumed with lunch and dinner. | Dietary supplement | Dietary Supplement: Formulation 1 |
| Placebo ComparatorParticipants will consume ió everyday for 4 weeks. Each sachet contains 4.5 g inulin and 6 g total fibre. Participants will consume one sachet daily in week 1 to allow acclimatisation, increasing to two sachets daily in weeks 2-4. Sachets are diluted in 500 mL of water and consumed with lunch and dinner. | Dietary supplement | Dietary Supplement: Formulation 2 |
Primary outcome
Fasting Plasma Glucose
Time frame: Baseline and 4 weeks (end of intervention).
Change in fasting plasma glucose measured from venous blood samples.
6 secondary outcomes
Anthropometric Measurements
Time frame: Baseline and 4 weeks (end of intervention).
HbA1c (Glycated Haemoglobin)
Time frame: Baseline and 4 weeks (end of intervention).
Inflammatory Markers
Time frame: Baseline and 4 weeks (end of intervention).
Gut Microbiota Composition
Time frame: Baseline and 4 weeks (end of intervention).
Gastrointestinal Symptoms
Time frame: Baseline and 4 weeks (end of intervention).
Dietary Intake
Time frame: Baseline and 4 weeks (end of intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adele Costabile, Prof study director
University of Roehampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ió everyday (a prebiotic- enriched gut health drink containing inulin) in people with Menopause, run by University of Roehampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Plasma Glucose (time frame: Baseline and 4 weeks (end of intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.