Gut Microbiota, Insulin Resistance, Metabolic Syndrome, Prebiotic, Type 2 Diabetes
Conditions
Keywords
inulin, type 2 diabetes, bifidobacterium, lactobacillus, gut microbiota, prebiotic, insulin resistance
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.
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.
Interventions
DIETARY_SUPPLEMENTAgave 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_SUPPLEMENTMaltodextrin (Placebo)
Participants will receive 10 g/day of maltodextrin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.
Sponsors
Universidad Autonoma de Queretaro
Instituto Nacional de Medicina Genomica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated hemoglobin (HbA1c) | Baseline and Week 8. | Glycated hemoglobin concentration (%) measured in venous blood samples to assess long-term glycemic control. |
| Change in insulin resistance (HOMA-IR | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting plasma glucose | Baseline and Week 8. | Fasting plasma glucose concentration (mg/dL) measured after a 12-hour overnight fast. |
| Change in fasting insulin | Baseline and Week 8. | Fasting serum insulin concentration (μU/mL) measured after a 12-hour overnight fast. |
| Change in total cholesterol | Baseline and Week 8. | Serum total cholesterol concentration (mg/dL). |
| Change in LDL-cholesterol | Baseline and Week 8. | Serum low-density lipoprotein cholesterol concentration (mg/dL). |
| Change in HDL-cholesterol | Baseline and Week 8. | Serum high-density lipoprotein cholesterol concentration (mg/dL). |
| Change in triglycerides | Baseline and Week 8. | Serum triglyceride concentration (mg/dL). |
| Change in intestinal abundance of Bifidobacterium | Baseline and Week 8. | Relative abundance of Bifidobacterium determined from fecal samples using 16S rRNA gene sequencing. |
| Change in intestinal abundance of Lactobacillaceae | Baseline and Week 8. | Relative abundance of Lactobacillaceae determined from fecal samples using 16S rRNA gene sequencing. |
| Change in body weight | Baseline and Week 8. | Body weight measured in kilograms using standardized procedures. |
| Change in body mass index (BMI) | Baseline and Week 8. | Body mass index calculated as weight (kg)/height (m²). |
| Change in waist circumference | Baseline and Week 8. | Waist circumference measured in centimeters using a non-elastic measuring tape. |
| Change in body fat percentage | Baseline and Week 8. | Body fat percentage assessed by bioelectrical impedance analysis. |
| Change in muscle mass percentage | Baseline and Week 8. | Muscle mass percentage assessed by bioelectrical impedance analysis. |
Countries
Mexico
Outcome results
None listed