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

27. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Kosttilskudd: 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 komparator: Dietary Supplement: Formulation 2
Calorie-matched comparator containing ~5 g maltodextrin
Kosttilskudd: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fasting Plasma Glucose
Tidsramme: Baseline and 4 weeks (end of intervention).
Change in fasting plasma glucose measured from venous blood samples.
Baseline and 4 weeks (end of intervention).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Anthropometric Measurements
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Roehampton

Etterforskere

  • Studieleder: Adele Costabile, Prof, University of Roehampton

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

10. juni 2026

Primær fullføring (Antatt)

20. januar 2027

Studiet fullført (Antatt)

15. mai 2027

Datoer for studieregistrering

Først innsendt

27. april 2026

Først innsendt som oppfylte QC-kriteriene

27. april 2026

Først lagt ut (Faktiske)

4. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • LSC-2025-14
  • Patterson-BIV-Sept25 (Annet stipend/finansieringsnummer: INFORM BBSRC)

Plan for individuelle deltakerdata (IPD)

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NEI

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