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.
研究概览
地位
条件
详细说明
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：ADELE COSTABILE, Prof
- 电话号码：3571 02083923571
- 邮箱：adele.costabile@roehampton.ac.uk
研究联系人备份
- 姓名：Savriniso Nazarova-Lewis, Master
- 电话号码：07535721482
- 邮箱：S.Nazarova-Lewis@roehampton.ac.uk
学习地点
-
-
UK
-
London、UK、英国、SW15 4JD
- Health Sciences Research Centre, Life Sciences Department, University of Roehampton
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
|
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.
|
|
安慰剂比较：Dietary Supplement: Formulation 2
Calorie-matched comparator containing ~5 g maltodextrin
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fasting Plasma Glucose
大体时间：Baseline and 4 weeks (end of intervention).
|
Change in fasting plasma glucose measured from venous blood samples.
|
Baseline and 4 weeks (end of intervention).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Anthropometric Measurements
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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).
|
合作者和调查者
调查人员
- 研究主任：Adele Costabile, Prof、University of Roehampton
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.