Effect of Agave Inulin Supplementation on Metabolic Profile and Intestinal Abundance of Bifidobacterium and Lactobacillaceae in Adults With Type 2 Diabetes Mellitus (INULIN-DM2)
6 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Aktiv, inte rekryterande
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
43
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Querétaro
-
Querétaro City, Querétaro, Mexiko, 76230
- Facultad de Ciencias Naturales, Campus Juriquilla
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: 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.
|
Participants will receive 10 g/day of maltodextrin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.
|
|
Experimentell: 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.
|
Participants will receive 10 g/day of agave inulin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in glycated hemoglobin (HbA1c)
Tidsram: Baseline and Week 8.
|
Glycated hemoglobin concentration (%) measured in venous blood samples to assess long-term glycemic control.
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Baseline and Week 8.
|
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Change in insulin resistance (HOMA-IR
Tidsram: Baseline and Week 8.
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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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in fasting plasma glucose
Tidsram: Baseline and Week 8.
|
Fasting plasma glucose concentration (mg/dL) measured after a 12-hour overnight fast.
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Baseline and Week 8.
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Change in fasting insulin
Tidsram: Baseline and Week 8.
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Fasting serum insulin concentration (μU/mL) measured after a 12-hour overnight fast.
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Baseline and Week 8.
|
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Change in total cholesterol
Tidsram: Baseline and Week 8.
|
Serum total cholesterol concentration (mg/dL).
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Baseline and Week 8.
|
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Change in LDL-cholesterol
Tidsram: Baseline and Week 8.
|
Serum low-density lipoprotein cholesterol concentration (mg/dL).
|
Baseline and Week 8.
|
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Change in HDL-cholesterol
Tidsram: Baseline and Week 8.
|
Serum high-density lipoprotein cholesterol concentration (mg/dL).
|
Baseline and Week 8.
|
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Change in triglycerides
Tidsram: Baseline and Week 8.
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Serum triglyceride concentration (mg/dL).
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Baseline and Week 8.
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Change in intestinal abundance of Bifidobacterium
Tidsram: Baseline and Week 8.
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Relative abundance of Bifidobacterium determined from fecal samples using 16S rRNA gene sequencing.
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Baseline and Week 8.
|
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Change in intestinal abundance of Lactobacillaceae
Tidsram: Baseline and Week 8.
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Relative abundance of Lactobacillaceae determined from fecal samples using 16S rRNA gene sequencing.
|
Baseline and Week 8.
|
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Change in body weight
Tidsram: Baseline and Week 8.
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Body weight measured in kilograms using standardized procedures.
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Baseline and Week 8.
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Change in body mass index (BMI)
Tidsram: Baseline and Week 8.
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Body mass index calculated as weight (kg)/height (m²).
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Baseline and Week 8.
|
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Change in waist circumference
Tidsram: Baseline and Week 8.
|
Waist circumference measured in centimeters using a non-elastic measuring tape.
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Baseline and Week 8.
|
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Change in body fat percentage
Tidsram: Baseline and Week 8.
|
Body fat percentage assessed by bioelectrical impedance analysis.
|
Baseline and Week 8.
|
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Change in muscle mass percentage
Tidsram: Baseline and Week 8.
|
Muscle mass percentage assessed by bioelectrical impedance analysis.
|
Baseline and Week 8.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2024
Primärt slutförande (Faktisk)
1 januari 2025
Avslutad studie (Beräknad)
1 augusti 2026
Studieregistreringsdatum
Först inskickad
6 juli 2026
Först inskickad som uppfyllde QC-kriterierna
6 juli 2026
Första postat (Faktisk)
10 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 011FCN2024
- UNIVERSİTY (Annan identifierare: KAHRAMANMARAŞ SÜTÇÜ İMAM UNİVERSİTY)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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