Development and Evaluation of a Probiotic-Enriched Prebiotic Supplement on Gut Microbiota in Individuals with Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- OUTCOME PARAMETERS:
研究概览
简要总结
This randomized controlled clinical trial aims to assess the influence of a probiotic-enriched prebiotic supplement on gut microbiota and glycemic parameters in individuals with uncontrolled Type 2 Diabetes Mellitus. The supplement will be developed using millet and pulses as prebiotic sources, and Lactobacillus acidophilus and Bacillus coagulans as probiotic strains. A total of 52 participants aged above 18 years with HbA1c levels between 10–14% and capillary blood glucose (CBG) levels of 250–400 mg/dl will be randomly assigned to an experimental or control group. The experimental group will receive the developed supplement along with standard dietary management for 15 weeks, while the control group will receive only dietary management.
Outcomes will include changes in gut microbiota (via fecal DNA extraction and 16S rRNA sequencing) and glycemic indicators such as HbA1c, CBG, FBS, PPBS, HOMA-IR, and CRP at baseline, midline, and endline. The study also includes product formulation, sensory evaluation, nutrient, microbial, and shelf-life analysis. Ethical clearance has been obtained, and informed consent will be taken from all participants.
Study duration: 3 years
Funding: Shri. N.P.V Udayar Research Fellowship
Location: Sri Ramachandra Medical Centre and SRH, SRIHER (DU), Chennai
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
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects will be included based on the following criteria: The study participants include people above 18 years with uncontrolled Type 2 diabetes has HbA1c (10-14%), and CBG (250-400mg/dl).
- •Willing to participate in the study, who are getting treatment at Sri Ramachandra Medical Centre and SRH.
排除标准
- •To exclude gestational and other diabetes types (maturity-onset diabetes of the young (MODY), type 1 diabetes, and Latent Autoimmune Diabetes in Adults (LADA).
- •To exclude subjects with any chronic illness and immunocompromised state (Chronic Kidney Disease, Chronic Liver Disease, oncological condition, and AIDS).
- •People who are allergic to the prescribed product.
- •On antibiotic supplements and steroid treatment.
结局指标
主要结局
OUTCOME PARAMETERS:
时间窗: Baseline (0 week): HbA1c, CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN | Midline (8th week): CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN | Endline (15th week): CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN
HbA1c, CBG, FBS, PPBS- Baseline, midline, and endline supplementation.
时间窗: Baseline (0 week): HbA1c, CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN | Midline (8th week): CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN | Endline (15th week): CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN
HOMA IR- Baseline, midline, and endline supplementation.
时间窗: Baseline (0 week): HbA1c, CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN | Midline (8th week): CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN | Endline (15th week): CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN
C-REACTIVE PROTEIN- Baseline, midline, and endline supplementation.
时间窗: Baseline (0 week): HbA1c, CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN | Midline (8th week): CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN | Endline (15th week): CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN
次要结局
- Fecal DNA extraction:(The gut microbiota is commonly measured through the fecal DNA extraction method. The fecal DNA extraction method will be measured to the randomly selected group after supplementation.)
研究者
Nithiya SL
Sri Ramachandra Institute of Higher Education and Research