Clinical validation of The Good Bug Glycemic Control and fiber supplementation on improvement in glycemic control, metabolic markers, and gut health in type 2 diabetic participants.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.Changes in Glycated Hemoglobin (HbA1c) levels.
研究概览
简要总结
The growing global epidemic of Type 2 Diabetes Mellitus (T2DM) necessitates innovative and comprehensive approaches to improve glycemic control and overall metabolic health. With 537 million adults affected worldwide and projections indicating a rise to 783 million by 2045, existing therapies often fail to achieve optimal glycemic control, underscoring the urgent need for novel interventions. Emerging evidence highlights the critical role of the gut microbiome in T2DM pathophysiology, where dysbiosis—characterized by reduced microbial diversity and a shift towards pro-inflammatory microbes—contributes to impaired short-chain fatty acid (SCFA) production, reduced incretin hormones, and increased gut permeability. These alterations exacerbate insulin resistance, glucose intolerance, and inflammation, creating a vicious cycle that complicates disease management. This study aims to clinically validate ’The Good Bug Glycemic Control and Fiber Supplementation’ by investigating its effects on glycemic control, metabolic markers, and gut health in T2DM participants. The proposed intervention leverages a synbiotic approach, combining selected probiotics (Lactobacillus acidophilus, L. reuteri, L. fermentum, Bifidobacterium bifidum) known to enhance insulin sensitivity, incretin levels, and reduce inflammation, with prebiotics (inulin, fructooligosaccharides, galactomannan) that promote SCFA production and slow glucose absorption. Additionally, addressing micronutrient dysregulation common in T2DM—including deficiencies in chromium, zinc, magnesium, and vitamins B9, B12, and D—is essential for improving insulin action and metabolic health. Furthermore, a comprehensive fiber strategy featuring ’The Good Bug Metabolic Fiber Boost,’ which includes glucomannan and Nutriose, is designed to enhance satiety, improve glycemic control, and increase insulin sensitivity. The potential impact of this multifaceted approach includes better glycemic control with reduced medication dependency, slower progression of diabetic complications, and a shift towards personalized, microbiome-centered T2DM management. By potentially reducing complication rates, this strategy could offer cost-effective long-term care. The significance of this study lies in testing a novel, integrated approach that targets the root causes of T2DM, potentially transforming clinical practice by establishing the gut microbiome as a primary therapeutic target. This could improve the quality of life for millions and alleviate the global healthcare burden associated with T2DM. Thus, the clinical validation of this innovative supplementation strategy represents a crucial step towards redefining T2DM management and offering new hope for better patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and females aged 30-45 years (both inclusive);2.Participants with glycated hemoglobin (HbA1c) levels 8 % to 11% (both inclusive);3.Participants diagnosed and treated for more than 6 months for type 2 diabetes;4.Participants on oral hypoglycemic (OHA) medication treatment alone or in combination with oral antidiabetic drugs (metformin and/or sulfonylureas only) in a stable dose for at least 3 months prior to randomization;5.Participants providing voluntary, written informed consent to participate in the study.
排除标准
- •1.Presence of Type I diabetes Mellitus (T1DM);
- •Participants receiving insulin/other injectables, antidiabetic drugs including 1 (GLP-1) analogues, dipeptidyl peptidase 4 (DPP4) inhibitors, etc.) except for those specified in the inclusion criteria;
- •Severe diabetes-related complications at screening (i.e., end-stage diabeticn kidney disease, neuropathy requiring pharmacological treatment, proliferative retinopathy, autonomic neuropathy, any neuro-motor conditions/neurogenic conditions);
- •Regular intake of any herbal phytoinsulin product, probiotics, prebiotics, or antibiotics for 3 months prior to inclusion;
- •Gastrointestinal disorders including food allergy, gluten-sensitive enteropathy, ulcerative colitis;
- •An uncontrolled cardiovascular or respiratory disease, an active malignant tumor, chronic infections, chronic bowel disorders, including but not limited to IBS;
- •Participant who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated);
- •Participants had undergone any surgical procedures within the previous six months;
- •Participation in another clinical trial;
- •Pregnancy or lactation as well as women with childbearing potential not taking adequate contraceptive precautions;
- •Participants with known renal and liver impairment;
- •Participants with a myocardial infarction or stroke within 6 months before study enrolment;
- •Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking;
- •Participants with diagnosed PCOD/ PCOS;
- •Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.
结局指标
主要结局
1.Changes in Glycated Hemoglobin (HbA1c) levels.
时间窗: 1. At screening and day 90 (end of the study). | 2. At screening, day 30, day 60, and day 90. | 3. At screening and day 90.
2. Changes in Fasting Plasma Glucose (FPG), postprandial plasma glucose (PPG),
时间窗: 1. At screening and day 90 (end of the study). | 2. At screening, day 30, day 60, and day 90. | 3. At screening and day 90.
fasting insulin levels, Homeostasis Model Assessment of Insulin Resistance
时间窗: 1. At screening and day 90 (end of the study). | 2. At screening, day 30, day 60, and day 90. | 3. At screening and day 90.
(HOMA-IR), and Homeostasis Model Assessment of Beta-Cell Function calculated (HOMA-B calculated).
时间窗: 1. At screening and day 90 (end of the study). | 2. At screening, day 30, day 60, and day 90. | 3. At screening and day 90.
3. Changes in Lipid Profile parameters (Total Cholesterol, LDL-C, HDL-C,
时间窗: 1. At screening and day 90 (end of the study). | 2. At screening, day 30, day 60, and day 90. | 3. At screening and day 90.
non-HDL-C, Triglycerides).
时间窗: 1. At screening and day 90 (end of the study). | 2. At screening, day 30, day 60, and day 90. | 3. At screening and day 90.
次要结局
- 1. Assessment of Body Mass Index (BMI)(2. Assessing Gut health using a Gastrointestinal Symptom Rating Scale)
研究者
Dr Manohar KN
Sharada Medical Centre