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

27 mei 2026 bijgewerkt door: DR ADELE COSTABILE, University of Roehampton

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Voedingssupplement: 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-vergelijker: Dietary Supplement: Formulation 2
Calorie-matched comparator containing ~5 g maltodextrin
Voedingssupplement: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fasting Plasma Glucose
Tijdsspanne: Baseline and 4 weeks (end of intervention).
Change in fasting plasma glucose measured from venous blood samples.
Baseline and 4 weeks (end of intervention).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Anthropometric Measurements
Tijdsspanne: Baseline and 4 weeks (end of intervention).
Change in body fat percentage measured using standardised clinical methods.
Baseline and 4 weeks (end of intervention).
HbA1c (Glycated Haemoglobin)
Tijdsspanne: Baseline and 4 weeks (end of intervention).
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
Tijdsspanne: Baseline and 4 weeks (end of intervention).
Change in circulating inflammatory markers associated with metabolic risk
Baseline and 4 weeks (end of intervention).
Gut Microbiota Composition
Tijdsspanne: Baseline and 4 weeks (end of intervention).
Changes in gut microbiota diversity and composition assessed via stool samples and 16S rRNA sequencing.
Baseline and 4 weeks (end of intervention).
Dietary Intake
Tijdsspanne: Baseline and 4 weeks (end of intervention).
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
Tijdsspanne: Baseline and 4 weeks (end of intervention).
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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Roehampton

Onderzoekers

  • Studie directeur: Adele Costabile, Prof, University of Roehampton

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

10 juni 2026

Primaire voltooiing (Geschat)

20 januari 2027

Studie voltooiing (Geschat)

15 mei 2027

Studieregistratiedata

Eerst ingediend

27 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 april 2026

Eerst geplaatst (Werkelijk)

4 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

27 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • LSC-2025-14
  • Patterson-BIV-Sept25 (Ander subsidie-/financieringsnummer: INFORM BBSRC)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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