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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Menopause
• Intervention / Treatment: Dietary supplement: ió everyday (a prebiotic- enriched gut health drink containing inulin); Dietary supplement: Placebo Comparator

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ADELE COSTABILE, Prof; Phone Number: 3571 02083923571; Email: adele.costabile@roehampton.ac.uk
• Study Contact Backup: Name: Savriniso Nazarova-Lewis, Master; Phone Number: 07535721482; Email: S.Nazarova-Lewis@roehampton.ac.uk

Study Locations

• United Kingdom
  • UK
    • London, UK, United Kingdom, SW15 4JD
      • Health Sciences Research Centre, Life Sciences Department, University of Roehampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria::

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dietary Supplement: Formulation 1; 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); 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 Comparator: Dietary Supplement: Formulation 2; Calorie-matched comparator containing ~5 g maltodextrin	Dietary supplement: Placebo Comparator; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Plasma Glucose	Change in fasting plasma glucose measured from venous blood samples.	Baseline and 4 weeks (end of intervention).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric Measurements	Change in body fat percentage measured using standardised clinical methods.	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).	Baseline and 4 weeks (end of intervention).
Inflammatory Markers	Change in circulating inflammatory markers associated with metabolic risk	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.	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.	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.	Baseline and 4 weeks (end of intervention).

Collaborators and Investigators

• Sponsor: University of Roehampton
• Investigators: Study Director: Adele Costabile, Prof, University of Roehampton

Study record dates

Study Major Dates

• Study Start (Estimated): June 10, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): May 15, 2027

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: diabetes; menopause; obesity
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus
• Other Study ID Numbers: LSC-2025-14; Patterson-BIV-Sept25 (Other Grant/Funding Number: INFORM BBSRC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No