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

27 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Complément alimentaire: 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.
Comparateur placebo: Dietary Supplement: Formulation 2
Calorie-matched comparator containing ~5 g maltodextrin
Complément alimentaire: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Fasting Plasma Glucose
Délai: Baseline and 4 weeks (end of intervention).
Change in fasting plasma glucose measured from venous blood samples.
Baseline and 4 weeks (end of intervention).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Anthropometric Measurements
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Roehampton

Les enquêteurs

  • Directeur d'études: Adele Costabile, Prof, University of Roehampton

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

10 juin 2026

Achèvement primaire (Estimé)

20 janvier 2027

Achèvement de l'étude (Estimé)

15 mai 2027

Dates d'inscription aux études

Première soumission

27 avril 2026

Première soumission répondant aux critères de contrôle qualité

27 avril 2026

Première publication (Réel)

4 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • LSC-2025-14
  • Patterson-BIV-Sept25 (Autre subvention/numéro de financement: INFORM BBSRC)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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