Type 2 DiabetesINULIN-DM2NCT07696247
Effect of Agave Inulin Supplementation on Metabolic Profile and Intestinal Abundance of Bifidobacterium and Lactobacillaceae in Adults With Type 2 Diabetes Mellitus
A study testing Agave Inulin in people with Type 2 Diabetes and Gut Microbiota, run by Universidad Autonoma de Queretaro at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Gut Microbiota, Insulin Resistance
- What is being tested?
- Agave Inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteMexico
- Study dates
- 1 Apr 2024to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Facultad de Ciencias Naturales, Campus Juriquilla
Querétaro City, Querétaro, 76230
About this study
Official 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
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.
Read the 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.
- Being tested
- Agave Inulin, Maltodextrin (Placebo)
- Keywords
- inulin, type 2 diabetes, bifidobacterium, lactobacillus, gut microbiota, prebiotic, insulin resistance
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agave InulinDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Agave Inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated hemoglobin (HbA1c)
Glycated hemoglobin concentration (%) measured in venous blood samples to assess long-term glycemic control.
Measured: 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.
Measured: Baseline and Week 8.
Secondary outcomes (13)
Change in fasting plasma glucose
Fasting plasma glucose concentration (mg/dL) measured after a 12-hour overnight fast.
Measured: Baseline and Week 8.
Change in fasting insulin
Fasting serum insulin concentration (μU/mL) measured after a 12-hour overnight fast.
Measured: Baseline and Week 8.
Change in total cholesterol
Serum total cholesterol concentration (mg/dL).
Measured: Baseline and Week 8.
Change in LDL-cholesterol
Serum low-density lipoprotein cholesterol concentration (mg/dL).
Measured: Baseline and Week 8.
Change in HDL-cholesterol
Serum high-density lipoprotein cholesterol concentration (mg/dL).
Measured: Baseline and Week 8.
Change in triglycerides
Serum triglyceride concentration (mg/dL).
Measured: Baseline and Week 8.
Change in intestinal abundance of Bifidobacterium
Relative abundance of Bifidobacterium determined from fecal samples using 16S rRNA gene sequencing.
Measured: Baseline and Week 8.
Change in intestinal abundance of Lactobacillaceae
Relative abundance of Lactobacillaceae determined from fecal samples using 16S rRNA gene sequencing.
Measured: Baseline and Week 8.
Change in body weight
Body weight measured in kilograms using standardized procedures.
Measured: Baseline and Week 8.
Change in body mass index (BMI)
Body mass index calculated as weight (kg)/height (m²).
Measured: Baseline and Week 8.
Change in waist circumference
Waist circumference measured in centimeters using a non-elastic measuring tape.
Measured: Baseline and Week 8.
Change in body fat percentage
Body fat percentage assessed by bioelectrical impedance analysis.
Measured: Baseline and Week 8.
Change in muscle mass percentage
Muscle mass percentage assessed by bioelectrical impedance analysis.
Measured: Baseline and Week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Apr 2024
- Primary completion1 Jan 2025
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Queretaro
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Medicina Genomica
- Responsible party
- Principal investigator, Olga Patricia García Obregon, Universidad Autonoma de Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696247
- Sponsor's protocol ID
- 011FCN2024
- Other IDs
- University
- Acronym
- INULIN-DM2
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07696247
- Acronym / sponsor ID
- INULIN-DM2 / 011FCN2024
- Keywords
- inulin, type 2 diabetes, bifidobacterium, lactobacillus, gut microbiota, prebiotic, insulin resistance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Universidad Autonoma de QueretaroUniversity, hospital or other
- Collaborators
- Instituto Nacional de Medicina Genomica
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin Placebo | Placebo comparator | 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. |
| Agave Inulin | Experimental | Dietary Supplement: Agave InulinParticipants will receive 10 g/day of agave inulin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Agave InulinParticipants 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 |
| 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 |
Primary outcome
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.
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.
13 secondary outcomes
Change in fasting plasma glucose
Time frame: Baseline and Week 8.
Change in fasting insulin
Time frame: Baseline and Week 8.
Change in total cholesterol
Time frame: Baseline and Week 8.
Change in LDL-cholesterol
Time frame: Baseline and Week 8.
Change in HDL-cholesterol
Time frame: Baseline and Week 8.
Change in triglycerides
Time frame: Baseline and Week 8.
Change in intestinal abundance of Bifidobacterium
Time frame: Baseline and Week 8.
Change in intestinal abundance of Lactobacillaceae
Time frame: Baseline and Week 8.
Change in body weight
Time frame: Baseline and Week 8.
Change in body mass index (BMI)
Time frame: Baseline and Week 8.
Change in waist circumference
Time frame: Baseline and Week 8.
Change in body fat percentage
Time frame: Baseline and Week 8.
Change in muscle mass percentage
Time frame: Baseline and Week 8.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agave Inulin in people with Type 2 Diabetes and Gut Microbiota, run by Universidad Autonoma de Queretaro at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated hemoglobin (HbA1c) (time frame: Baseline and Week 8.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.