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

NCT07565675 | Not Yet Recruiting DMC

• 2 other identifiers: LSC-2025-14Patterson-BIV-Sept25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 (Mauvais-Jarvis et al., 2017; Yazdkhasti et al., 2024). Recent evidence suggests that the gut microbiota plays an important role in metabolic regulation and glucose homeostasis (Megur et al., 2022; Hutkins et al., 2024). Menopause-related hormonal changes may alter the composition and function of the gut microbiome, with downstream effects on insulin sensitivity. Additionally, certain gut bacteria (ie. Bifidobacterium species) regulate circulating oestrogen via β-glucuronidase activity, highlighting a potential interaction between microbial composition and hormonal balance (Ding et al., 2014). Observational findings, including those from the MILES study, support associations between menopausal stage, gut microbiota alterations, and insulin homeostasis (Maffei et al., 2025). Prebiotics are non-digestible compounds that selectively stimulate beneficial gut bacteria and may improve metabolic outcomes (Adak et al., 2019). 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 T2DM (Chambers et al., 2015; Hall el al., (2024). 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). This study aims to investigate the effect of daily consumption of an inulin-containing prebiotic gut health drink called 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 exploring changes in metabolic markers and assessing the role of the gut microbiota in mediating these effects. We hypothesise that consumption of ió everyday will improve glucose control in prediabetic women who have recently undergone menopause. This hypothesis is supported by evidence 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 our 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.

Conditions

Menopause

Keywords

menopause; diabetes; obesity

Outcome Measures

Primary Outcomes (1)

• Fasting Plasma Glucose

  Change in fasting plasma glucose measured from venous blood samples.

  Baseline and 4 weeks (end of intervention).

Secondary Outcomes (6)

• Anthropometric Measurements

  Baseline and 4 weeks (end of intervention).

• HbA1c (Glycated Haemoglobin)

  Baseline and 4 weeks (end of intervention).

• Inflammatory Markers

  Baseline and 4 weeks (end of intervention).

• Gut Microbiota Composition

  Baseline and 4 weeks (end of intervention).

• Gastrointestinal Symptoms

  Baseline and 4 weeks (end of intervention).

Study Arms (2)

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.

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

Dietary Supplement: Placebo Comparator

Interventions

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.

Dietary Supplement: Formulation 1

Placebo Comparator DIETARY_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.

Dietary Supplement: Formulation 2

Eligibility Criteria

• Age: 45 Years - 60 Years
• Gender Eligibility Details: Postmenopausal Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roehampton: lead

Study Sites (1)

Health Sciences Research Centre, Life Sciences Department, University of Roehampton

London, UK, SW15 4JD, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adele Costabile, Prof

  University of Roehampton

  STUDY DIRECTOR

Central Study Contacts

ADELE COSTABILE, Prof

CONTACT

02083923571; adele.costabile@roehampton.ac.uk

Savriniso Nazarova-Lewis, Master

CONTACT

07535721482; S.Nazarova-Lewis@roehampton.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In addition to participants and investigators, laboratory personnel analysing biological samples and statisticians conducting the data analysis will be blinded to group allocation. Samples and datasets will be coded to maintain masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: School of Life and Health Sciences University of Roehampton | London | SW15 4JD

Model Details: 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 Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): June 10, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)