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

NCT07696247 | Active Not Recruiting

• 2 other identifiers: 011FCN2024University
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Gut Microbiota; Insulin Resistance; Metabolic Syndrome; Prebiotic

Keywords

inulin; type 2 diabetes; bifidobacterium; lactobacillus; gut microbiota; prebiotic; insulin resistance

Outcome Measures

Primary Outcomes (2)

• Change in glycated hemoglobin (HbA1c)

  Glycated hemoglobin concentration (%) measured in venous blood samples to assess long-term glycemic control.

  Baseline and Week 8.

• Change in insulin resistance (HOMA-IR

  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 Outcomes (13)

• 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.

Study Arms (2)

Maltodextrin Placebo

PLACEBO COMPARATOR

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)

Agave Inulin

EXPERIMENTAL

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

Interventions

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.

Agave Inulin

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.

Maltodextrin Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Queretaro: lead
• Instituto Nacional de Medicina Genomica: collaborator

Study Sites (1)

Facultad de Ciencias Naturales, Campus Juriquilla

Querétaro City, Querétaro, 76230, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Metabolic Syndrome

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to one of two parallel groups to receive either agave inulin (10 g/day) or a placebo (10 g/day of maltodextrin) for eight weeks. Randomization will be performed using a computer-generated allocation sequence, and both participants and investigators will remain blinded to treatment assignment throughout the study. Outcomes related to metabolic profile, body composition, and intestinal abundance of Bifidobacterium and Lactobacillaceae will be assessed at baseline and at the end of the intervention.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: April 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: August 1, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)