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NCT Number: NCT07696247

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Gut Microbiota Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Prebiotic

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Ciencias Naturales, Campus Juriquilla

Querétaro City, Querétaro, 76230, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Agave Inulin

Dietary Supplement

Participants will receive 10 g/day of agave inulin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.

Maltodextrin (Placebo)

Dietary Supplement

Participants will receive 10 g/day of maltodextrin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in fasting plasma glucose

    Time frame: Baseline and Week 8.

    Fasting plasma glucose concentration (mg/dL) measured after a 12-hour overnight fast.

  2. Change in fasting insulin

    Time frame: Baseline and Week 8.

    Fasting serum insulin concentration (μU/mL) measured after a 12-hour overnight fast.

  3. Change in total cholesterol

    Time frame: Baseline and Week 8.

    Serum total cholesterol concentration (mg/dL).

  4. Change in LDL-cholesterol

    Time frame: Baseline and Week 8.

    Serum low-density lipoprotein cholesterol concentration (mg/dL).

  5. Change in HDL-cholesterol

    Time frame: Baseline and Week 8.

    Serum high-density lipoprotein cholesterol concentration (mg/dL).

  6. Change in triglycerides

    Time frame: Baseline and Week 8.

    Serum triglyceride concentration (mg/dL).

  7. 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.

  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.

  9. Change in body weight

    Time frame: Baseline and Week 8.

    Body weight measured in kilograms using standardized procedures.

  10. Change in body mass index (BMI)

    Time frame: Baseline and Week 8.

    Body mass index calculated as weight (kg)/height (m²).

  11. Change in waist circumference

    Time frame: Baseline and Week 8.

    Waist circumference measured in centimeters using a non-elastic measuring tape.

  12. Change in body fat percentage

    Time frame: Baseline and Week 8.

    Body fat percentage assessed by bioelectrical impedance analysis.

  13. Change in muscle mass percentage

    Time frame: Baseline and Week 8.

    Muscle mass percentage assessed by bioelectrical impedance analysis.

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Queretaro

Other

Collaborators

  • Instituto Nacional de Medicina Genomica

Registry information

Official study title

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

Acronym: INULIN-DM2

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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