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

July 6, 2026 updated by: 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Querétaro
      • Querétaro City, Querétaro, Mexico, 76230
        • Facultad de Ciencias Naturales, Campus Juriquilla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Dietary supplement: 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.
Experimental: 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.
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycated hemoglobin (HbA1c)
Time Frame: 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
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fasting plasma glucose
Time Frame: 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
Time Frame: 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
Time Frame: Baseline and Week 8.
Serum total cholesterol concentration (mg/dL).
Baseline and Week 8.
Change in LDL-cholesterol
Time Frame: Baseline and Week 8.
Serum low-density lipoprotein cholesterol concentration (mg/dL).
Baseline and Week 8.
Change in HDL-cholesterol
Time Frame: Baseline and Week 8.
Serum high-density lipoprotein cholesterol concentration (mg/dL).
Baseline and Week 8.
Change in triglycerides
Time Frame: Baseline and Week 8.
Serum triglyceride concentration (mg/dL).
Baseline and Week 8.
Change in intestinal abundance of Bifidobacterium
Time Frame: 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
Time Frame: 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
Time Frame: Baseline and Week 8.
Body weight measured in kilograms using standardized procedures.
Baseline and Week 8.
Change in body mass index (BMI)
Time Frame: Baseline and Week 8.
Body mass index calculated as weight (kg)/height (m²).
Baseline and Week 8.
Change in waist circumference
Time Frame: Baseline and Week 8.
Waist circumference measured in centimeters using a non-elastic measuring tape.
Baseline and Week 8.
Change in body fat percentage
Time Frame: Baseline and Week 8.
Body fat percentage assessed by bioelectrical impedance analysis.
Baseline and Week 8.
Change in muscle mass percentage
Time Frame: Baseline and Week 8.
Muscle mass percentage assessed by bioelectrical impedance analysis.
Baseline and Week 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Queretaro

Collaborators

Instituto Nacional de Medicina Genomica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 6, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 011FCN2024
  • University (Other Identifier: Universidad Autónoma de Querétaro)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metabolic Syndrome

Clinical Trials on Maltodextrin (Placebo)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe