A randomized, double blind, parallel, placebo-controlled study to evaluate metabolic health and gut microbiome in presence of SucroSEB and SEB TG and to determine their safety in diabetic adults
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Gut microbiome from baseline to end of treatment (assessment on Day 1 and Day 180)
研究概览
简要总结
In the most recent studies, the research conducted emphasizes the importance of focusing on the interplay between the gut microbiome and metabolic control, particularly with attention on how it mediates glucose metabolism. T2DM may also be seen as a consequence of gut dysfunction, termed as gut dysbiosis, due to the imbalanced structure and functional diversity of the gut microbiota. It has also been shown that dysbiosis inclines the body towards having an increased state of inflammation along with insulin resistance and also elevated levels of gut permeability which combine to deteriorate the metabolic processes. Hence, several studies have pointed to the gut microbiome also as an important target for treating T2DM and improving metabolic health. This has opened up the avenue for combinatorial therapies using enzymes and probiotics that could affect carbohydrate metabolism in addition to targeting gut health.
Enzyme blends SEB TG and SucroSEB provide a unique combination of metabolic modulation and microbiome-oriented therapeutics that can be utilized as a metabolic therapy. SEB TG targets starch-like substances and produces slowly digestible oligosaccharides that can withstand rapid degradation within the intestine. These oligosaccharides, also promote the growth of intestinal bacteria thus exerting prebiotic effect. SucroSEB, on the other hand, hydrolyzes sucrose and would produce fibers; thus, may be able to blunt postprandial blood glucose responses and further aid the gut microbiota. These formulations aimed at reducing dysglycemia would enhance indicators of the metabolic syndrome and the normal function of the gut microbial structure.
The SEB TG and SucroSEB are being evaluated under the consideration that these formulations may be included in the therapy of patients with diabetes for two main reasons: Improvement of Metabolic Parameters: The SEB TG and SucroSEB supplementation would reduce the glycemic index of the offending carbohydrates as these ingredients retard carbohydrate digestion and control discharge of free glucose into blood circulation. This dietary modification should help to lower post prandial glucose elevations, which would help protect against glucose toxicity, one of the main causes of insulin resistance. In addition, there is evidence supporting the production of prebiotic fibers from enzymatic action (under in-vitro conditions) that would enhance insulin sensitivity, normalizes hepatic glucose output, and decrease inflammation, all of which are essential for sustaining metabolic balance. Modulation of the Gut Microbiota: The emergence of links between gut dysbiosis and T2DM has consolidated the view that maintaining a healthy microbiome is essential for improving metabolic health. SEB TG and SucroSEB would promote the growth of good bacteria in the intestine by incorporating prebiotic fibers that help in balancing glucose metabolism and insulin sensitivity. Furthermore, these enzymes, by promoting a healthy gut microbiota, may lower systemic inflammation and promote gut barrier function thereby reducing the negative impact of hyperglycemia.
Given their role in regulating metabolism plus the microbiome health, these enzymes can serve as a new treatment option for patients suffering from T2DM. These enzymes not only tackle dysglycemia but also the causative dysbiosis, which renders them ideal for diabetes management. The current clinical trial seeks to evaluate the biological functions of SEB TG and SucroSEB while investigating their capacities to alter the gut microflora, enhance glucose metabolism and reinforce health and wellness in general. In this dual approach SEB TG and SucroSEB create new opportunities to enhance metabolic effectiveness and prevent long-term diabetes related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects with less physical activity.
- •BMI 18.5 to 35 Kg/m
- •Subjects with recent HbA1c reports within 2 weeks can be considered as screening value for participation in the study.
- •Subjects taking stable medicine dose for past 3 months.
- •Subjects who occasionally consume sweets/beverages containing sugar.
- •Subjects with fasting blood sugar level greater than or equal to 130 mg/dL and HbA1c 7.0 to 11.0%.
- •Subjects must have a history of diabetes for more than 1 year and have been on a stable medication.
- •regimen for at least the past 9 months.
- •Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
排除标准
- •Pregnant and lactating female
- •Subjects with BMI greater than or equal to 35
- •Type I diabetic patients
- •HbA1c less than 7.0 and greater than 11.0%
- •Diabetes medication (DPP4 inhibitors, Acarbose, Voglibose, Repaglinide, GLP-1 receptor agonists (GLP1RA), and Insulin)
- •Patients with major chronic complications (including but not limited to) autoimmune disease, inflammation, etc.
- •Organic insufficiency (cardiac, hepatic, renal, respiratory)
- •Use of food supplements specifically containing fibers or polysaccharides
- •Chronic smoking and alcohol intake
- •Allergy to the ingredients in the test product.
- •History of any surgery in the past 3 months.
- •Subject currently taking or has in the past 30 days used GI related probiotics/prebiotics or any enzymes [prescription or over the counter (OTC)].
结局指标
主要结局
Change in Gut microbiome from baseline to end of treatment (assessment on Day 1 and Day 180)
时间窗: 180 days
次要结局
- 1. Change in HbA1c (assessment on Day -1 to Day -7, Day 90 & Day 180)(2. Change in fasting blood glucose (assessment on Day -1 to Day -7, Day 90 & Day 180))
- 8. Liver & Renal safety analysis (assessment on Day 1, Day 90 & Day 180)- Check levels of AST, ALT, hsCRP, BUN, total albumin & globulin.(9. CBC analysis & vital sign check (assessment on Day 1, Day 90 & Day 180))
- 12. Rate of incidence of AE & SAEs - Recording any adverse (AE) or serious adverse event (SAE) from Day 1 to Day 180.(180 days)
研究者
Dr Harsha Pamnani
Dr Harsha Pamnani
