Ex-vivo and in vivo effects of plant intrinsic fibre drink on the gut microbiome of healthy and metabolic syndrome subjects
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- For Part A: Compare the effect of freeze dried fibre rich fibre food on propensity to
研究概览
简要总结
The translational study, titled “Ex-vivo and in vivo effects of plant intrinsic fibre drink on the gut microbiome of healthy and metabolic syndrome subjectsâ€, investigates the impact of Potion1st Smoothie formulations on gut microbiome diversity and metabolic health biomarkers. Conducted in two parts, the study evaluates both ex vivo and in vivo effects of dietary fibers on the gut microbiome (GM). Part A analyzes microbiome changes and short-chain fatty acid (SCFA) production through the incubation of stool samples with fiber-rich formulations. Part B involves a 21-day intervention where participants consume three smoothies daily, before meals, to assess their effects on microbiome diversity, biomarkers of metabolic health, and systemic health parameters through stool and blood analyses.
The primary objective is to assess whether Potion1st Smoothie formulations enhance gut microbiome diversity and influence biomarkers of metabolic health. Additionally, the study seeks to determine if ex vivo findings reliably predict in vivo outcomes, offering a framework for rapid dietary fiber research. Secondary goals include profiling GM metabolites, evaluating blood biochemistry, and calculating the Gut Microbiome Health Index (GMHI). This dual-phase design emphasizes diverse plant fibers and aims to validate a model for studying the therapeutic potential of dietary interventions in improving gut and metabolic health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participant Inclusion Criteria (Healthy Volunteers) a.
- •Between 25 to 60 years of age b.
- •Healthy volunteers with no diagnosed chronic disorder.
- •Those willing to abide by the requirements and conditions of the study and agreeing to provide written informed consent Participant Inclusion Criteria (Metabolic Syndrome) a.
- •Patients of either sex diagnosed with metabolic syndrome with three or more of the following criteria as per NCEP/ ATP III, and not currently on any medications, as the trial aims to assess the efficacy of dietary intervention alone.
- •Abdominal obesity: Having a waist circumference greater than 40 inches for men and 35 inches for women when measured at the umbilical region.
- •Elevated Blood Pressure: Having systolic blood pressure of 130 mm Hg or higher, or diastolic blood pressure of 85 mm Hg or higher.
- •High Blood Glucose Levels: Having fasting plasma glucose levels above 110 mg/dL iv.
- •Triglyceride Levels: Having elevated triglyceride levels of 150 mg/dL or higher.
- •Low HDL Cholesterol Levels: Having low HDL cholesterol levels below 40 mg/dL for men and below 50 mg/dL for women.
- •Between 25 and 60 years of age c.
- •Those willing to abide by the requirements and conditions of the study and agreeing to provide written informed consent.
排除标准
- •Participant Exclusion Criteria (for both Healthy and Metabolic Syndrome) Exclusion criteria for participants of either group are the same as follows:
- •Currently on any medication.
- •Known allergies to any food product.
- •Pregnant or lactating women.
- •Individuals with any malignant disorder currently or in the past.
- •Individuals with psychiatric disorders or those with substance abuse.
- •Individuals who have been on antibiotics in the last 3 months.
- •Participants who have been involved in any other clinical trial within the last 6 months.
- •Participants who have undergone major surgery within the last 6 months.
- •Participants who have experienced significant weight changes (more than 5% of body weight) in the past 3 months.
- •Individuals consuming more than 14 units of alcohol per week for women and more than 21 units per week for men.
结局指标
主要结局
For Part A: Compare the effect of freeze dried fibre rich fibre food on propensity to
时间窗: 21 days
generate microbiome derived metabolites specifically short chain fatty acids.
时间窗: 21 days
For Part B: To evaluate the effectiveness of the dietary intervention on gut health by
时间窗: 21 days
quantifying changes in the Gut Microbiome Health Index (GMHI).
时间窗: 21 days
次要结局
- Blood biochemistry to assess metabolic health, estimation of microbiome metabolites(Day 21)
- To study the correlation between the changes in gut microbiome induced(by high fibre foods by ex vivo incubation and following in vivo)
研究者
Dr Madhur Motwani
Proxi Farma Pvt Ltd