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Effect of Agave Inulin Supplementation on Metabolic Profile and Intestinal Abundance of Bifidobacterium and Lactobacillaceae in Adults With Type 2 Diabetes Mellitus (INULIN-DM2)

2026年7月6日 更新者：Olga Patricia García Obregon、Universidad Autonoma de Queretaro

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

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.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

43

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 墨西哥
    • Querétaro
      • Querétaro City、Querétaro、墨西哥、76230
        • Facultad de Ciencias Naturales, Campus Juriquilla

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Maltodextrin Placebo
Participants will receive 10 g/day of maltodextrin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.
膳食补充剂：Maltodextrin (Placebo)
Participants will receive 10 g/day of maltodextrin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.
实验性的：Agave Inulin
Participants will receive 10 g/day of agave inulin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.
膳食补充剂：Agave Inulin
Participants will receive 10 g/day of agave inulin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in glycated hemoglobin (HbA1c)
大体时间：Baseline and Week 8.
Glycated hemoglobin concentration (%) measured in venous blood samples to assess long-term glycemic control.
Baseline and Week 8.
Change in insulin resistance (HOMA-IR
大体时间：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.
Baseline and Week 8.

次要结果测量

结果测量
措施说明
大体时间
Change in fasting plasma glucose
大体时间：Baseline and Week 8.
Fasting plasma glucose concentration (mg/dL) measured after a 12-hour overnight fast.
Baseline and Week 8.
Change in fasting insulin
大体时间：Baseline and Week 8.
Fasting serum insulin concentration (μU/mL) measured after a 12-hour overnight fast.
Baseline and Week 8.
Change in total cholesterol
大体时间：Baseline and Week 8.
Serum total cholesterol concentration (mg/dL).
Baseline and Week 8.
Change in LDL-cholesterol
大体时间：Baseline and Week 8.
Serum low-density lipoprotein cholesterol concentration (mg/dL).
Baseline and Week 8.
Change in HDL-cholesterol
大体时间：Baseline and Week 8.
Serum high-density lipoprotein cholesterol concentration (mg/dL).
Baseline and Week 8.
Change in triglycerides
大体时间：Baseline and Week 8.
Serum triglyceride concentration (mg/dL).
Baseline and Week 8.
Change in intestinal abundance of Bifidobacterium
大体时间：Baseline and Week 8.
Relative abundance of Bifidobacterium determined from fecal samples using 16S rRNA gene sequencing.
Baseline and Week 8.
Change in intestinal abundance of Lactobacillaceae
大体时间：Baseline and Week 8.
Relative abundance of Lactobacillaceae determined from fecal samples using 16S rRNA gene sequencing.
Baseline and Week 8.
Change in body weight
大体时间：Baseline and Week 8.
Body weight measured in kilograms using standardized procedures.
Baseline and Week 8.
Change in body mass index (BMI)
大体时间：Baseline and Week 8.
Body mass index calculated as weight (kg)/height (m²).
Baseline and Week 8.
Change in waist circumference
大体时间：Baseline and Week 8.
Waist circumference measured in centimeters using a non-elastic measuring tape.
Baseline and Week 8.
Change in body fat percentage
大体时间：Baseline and Week 8.
Body fat percentage assessed by bioelectrical impedance analysis.
Baseline and Week 8.
Change in muscle mass percentage
大体时间：Baseline and Week 8.
Muscle mass percentage assessed by bioelectrical impedance analysis.
Baseline and Week 8.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Universidad Autonoma de Queretaro

合作者

Instituto Nacional de Medicina Genomica

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年4月1日

初级完成 (实际的)

2025年1月1日

研究完成 (估计的)

2026年8月1日

研究注册日期

首次提交

2026年7月6日

首先提交符合 QC 标准的

2026年7月6日

首次发布 (实际的)

2026年7月10日

研究记录更新

最后更新发布 (实际的)

2026年7月10日

上次提交的符合 QC 标准的更新

2026年7月6日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 011FCN2024
  • UNIVERSİTY (其他标识符：KAHRAMANMARAŞ SÜTÇÜ İMAM UNİVERSİTY)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data (IPD) will not be shared because participant consent for public data sharing was not obtained, and no formal data-sharing plan or repository was established at the time of study initiation. Data will be used solely for the purposes described in the approved research protocol and in accordance with institutional ethical guidelines.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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