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 oppdatert 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
43
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Querétaro
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Querétaro City, Querétaro, Mexico, 76230
- Facultad de Ciencias Naturales, Campus Juriquilla
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: 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.
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Participants will receive 10 g/day of maltodextrin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.
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Eksperimentell: 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.
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Participants will receive 10 g/day of agave inulin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in glycated hemoglobin (HbA1c)
Tidsramme: Baseline and Week 8.
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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
Tidsramme: 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.
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Baseline and Week 8.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in fasting plasma glucose
Tidsramme: Baseline and Week 8.
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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
Tidsramme: 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
Tidsramme: Baseline and Week 8.
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Serum total cholesterol concentration (mg/dL).
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Baseline and Week 8.
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Change in LDL-cholesterol
Tidsramme: Baseline and Week 8.
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Serum low-density lipoprotein cholesterol concentration (mg/dL).
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Baseline and Week 8.
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Change in HDL-cholesterol
Tidsramme: Baseline and Week 8.
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Serum high-density lipoprotein cholesterol concentration (mg/dL).
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Baseline and Week 8.
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Change in triglycerides
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and Week 8.
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Relative abundance of Lactobacillaceae determined from fecal samples using 16S rRNA gene sequencing.
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Baseline and Week 8.
|
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Change in body weight
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline and Week 8.
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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
Tidsramme: Baseline and Week 8.
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Body fat percentage assessed by bioelectrical impedance analysis.
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Baseline and Week 8.
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Change in muscle mass percentage
Tidsramme: Baseline and Week 8.
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Muscle mass percentage assessed by bioelectrical impedance analysis.
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Baseline and Week 8.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. april 2024
Primær fullføring (Faktiske)
1. januar 2025
Studiet fullført (Antatt)
1. august 2026
Datoer for studieregistrering
Først innsendt
6. juli 2026
Først innsendt som oppfylte QC-kriteriene
6. juli 2026
Først lagt ut (Faktiske)
10. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 011FCN2024
- UNIVERSİTY (Annen identifikator: KAHRAMANMARAŞ SÜTÇÜ İMAM UNİVERSİTY)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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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Nei
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