Effects of Eight Weeks of Agave Inulin Supplementation on Metabolic Profile and Intestinal Abundance of Bifidobacterium and Lactobacillaceae in Adults With Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Change in glycated hemoglobin (HbA1c)
研究概览
简要总结
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effects of agave inulin supplementation on metabolic profile and intestinal abundance of Bifidobacterium and Lactobacillaceae in adults with type 2 diabetes mellitus. Participants will receive either 10 g/day of agave inulin or a placebo for eight weeks. Clinical, anthropometric, biochemical, and gut microbiota assessments will be performed at baseline and at the end of the intervention. The study seeks to determine whether agave inulin supplementation improves metabolic outcomes and modulates beneficial intestinal microorganisms associated with metabolic health in adults with type 2 diabetes mellitus.
详细描述
This randomized, double-blind, placebo-controlled, parallel-group clinical trial will evaluate the effects of agave inulin supplementation on metabolic profile and intestinal abundance of Bifidobacterium and Lactobacillaceae in adults with type 2 diabetes mellitus (T2DM).
Participants will be randomly assigned to receive either agave inulin (10 g/day) or placebo for eight weeks. The intervention will be administered as two daily doses of 5 g consumed before breakfast and before dinner.
Metabolic assessments will be performed at baseline and week 8 and will include fasting glucose, fasting insulin, glycated hemoglobin (HbA1c), insulin resistance (HOMA-IR), total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides. Anthropometric and body composition measurements, including body weight, body mass index (BMI), waist circumference, body fat percentage, and muscle mass percentage, will also be evaluated.
Fecal samples will be collected at baseline and week 8, preserved in DNA/RNA Shield solution, and stored at -80°C until analysis. Microbial DNA will be extracted using the ZymoBIOMICS™ DNA Miniprep Kit. Gut microbiota characterization will be performed through 16S rRNA gene sequencing of the V4 hypervariable region using primers 515F and 806R on the Illumina MiSeq platform. Bioinformatic analyses will be conducted using the QIIME pipeline to determine the abundance of Bifidobacterium and Lactobacillaceae. Statistical analyses will be performed according to the intention-to-treat principle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants and investigators will remain blinded to treatment allocation throughout the study. Agave inulin and placebo will be provided in identical sachets with similar appearance, texture, and packaging. Treatment codes will remain concealed until completion of data collection.
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of type 2 diabetes mellitus.
- •Age between 20 and 75 years.
- •Residence in Querétaro, Mexico.
- •Stable oral hypoglycemic treatment and/or basal insulin.
- •Ability to provide informed consent.
排除标准
- •HbA1c > 9.5%.
- •Current use of probiotics, prebiotics, synbiotics, or fiber supplements within the previous 3 months.
- •Use of alpha-glucosidase inhibitors.
- •Severe cardiovascular disease.
- •Chronic kidney disease stage 3b or higher.
- •Active gastrointestinal disease.
- •Pregnancy or lactation.
- •Known allergy to agave or fructans.
结局指标
主要结局
Change in glycated hemoglobin (HbA1c)
时间窗: Baseline and Week 8.
Glycated hemoglobin concentration (%) measured in venous blood samples to assess long-term glycemic control.
Change in insulin resistance (HOMA-IR
时间窗: Baseline and Week 8.
Insulin resistance estimated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated as \[fasting glucose (mg/dL) × fasting insulin (μU/mL)\]/405.
次要结局
- Change in body weight(Baseline and Week 8.)
- Change in body mass index (BMI)(Baseline and Week 8.)
- Change in waist circumference(Baseline and Week 8.)
- Change in body fat percentage(Baseline and Week 8.)
- Change in muscle mass percentage(Baseline and Week 8.)
- Change in fasting plasma glucose(Baseline and Week 8.)
- Change in fasting insulin(Baseline and Week 8.)
- Change in total cholesterol(Baseline and Week 8.)
- Change in LDL-cholesterol(Baseline and Week 8.)
- Change in HDL-cholesterol(Baseline and Week 8.)
- Change in triglycerides(Baseline and Week 8.)
- Change in intestinal abundance of Bifidobacterium(Baseline and Week 8.)
- Change in intestinal abundance of Lactobacillaceae(Baseline and Week 8.)
研究者
Olga Patricia García Obregon
Professor
Universidad Autonoma de Queretaro