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

27 maj 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Inte tillämpbar

Kontakter och platser

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Studiekontakt

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / 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.
Kosttillskott: 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-jämförare: Dietary Supplement: Formulation 2
Calorie-matched comparator containing ~5 g maltodextrin
Kosttillskott: 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.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Anthropometric Measurements
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Roehampton

Utredare

  • Studierektor: Adele Costabile, Prof, University of Roehampton

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

10 juni 2026

Primärt slutförande (Beräknad)

20 januari 2027

Avslutad studie (Beräknad)

15 maj 2027

Studieregistreringsdatum

Först inskickad

27 april 2026

Först inskickad som uppfyllde QC-kriterierna

27 april 2026

Första postat (Faktisk)

4 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • LSC-2025-14
  • Patterson-BIV-Sept25 (Annat bidrag/finansieringsnummer: INFORM BBSRC)

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