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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: ADELE COSTABILE, Prof
- Número de teléfono: 3571 02083923571
- Correo electrónico: adele.costabile@roehampton.ac.uk
Copia de seguridad de contactos de estudio
- Nombre: Savriniso Nazarova-Lewis, Master
- Número de teléfono: 07535721482
- Correo electrónico: S.Nazarova-Lewis@roehampton.ac.uk
Ubicaciones de estudio
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UK
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London, UK, Reino Unido, SW15 4JD
- Health Sciences Research Centre, Life Sciences Department, University of Roehampton
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: 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.
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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.
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Comparador de placebos: Dietary Supplement: Formulation 2
Calorie-matched comparator containing ~5 g maltodextrin
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Fasting Plasma Glucose
Periodo de tiempo: Baseline and 4 weeks (end of intervention).
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Change in fasting plasma glucose measured from venous blood samples.
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Baseline and 4 weeks (end of intervention).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Anthropometric Measurements
Periodo de tiempo: Baseline and 4 weeks (end of intervention).
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Change in body fat percentage measured using standardised clinical methods.
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Baseline and 4 weeks (end of intervention).
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HbA1c (Glycated Haemoglobin)
Periodo de tiempo: Baseline and 4 weeks (end of intervention).
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Change in HbA1c as an exploratory marker of glycaemic control (interpretation is limited due to the short 4-week intervention duration).
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Baseline and 4 weeks (end of intervention).
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Inflammatory Markers
Periodo de tiempo: Baseline and 4 weeks (end of intervention).
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Change in circulating inflammatory markers associated with metabolic risk
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Baseline and 4 weeks (end of intervention).
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Gut Microbiota Composition
Periodo de tiempo: Baseline and 4 weeks (end of intervention).
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Changes in gut microbiota diversity and composition assessed via stool samples and 16S rRNA sequencing.
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Baseline and 4 weeks (end of intervention).
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Dietary Intake
Periodo de tiempo: Baseline and 4 weeks (end of intervention).
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Change in habitual dietary intake assessed using 4-day food records at baseline and after 4 weeks.
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Baseline and 4 weeks (end of intervention).
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Gastrointestinal Symptoms
Periodo de tiempo: Baseline and 4 weeks (end of intervention).
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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.
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Baseline and 4 weeks (end of intervention).
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Adele Costabile, Prof, University of Roehampton
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LSC-2025-14
- Patterson-BIV-Sept25 (Otro número de subvención/financiamiento: INFORM BBSRC)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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