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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 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

43

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Mexico
    • Querétaro
      • Querétaro City, Querétaro, Mexico, 76230
        • Facultad de Ciencias Naturales, Campus Juriquilla

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
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.
Kosttilskud: 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.
Eksperimentel: 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.
Kosttilskud: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in glycated hemoglobin (HbA1c)
Tidsramme: Baseline and Week 8.
Glycated hemoglobin concentration (%) measured in venous blood samples to assess long-term glycemic control.
Baseline and Week 8.
Change in insulin resistance (HOMA-IR
Tidsramme: 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.
Baseline and Week 8.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in fasting plasma glucose
Tidsramme: Baseline and Week 8.
Fasting plasma glucose concentration (mg/dL) measured after a 12-hour overnight fast.
Baseline and Week 8.
Change in fasting insulin
Tidsramme: Baseline and Week 8.
Fasting serum insulin concentration (μU/mL) measured after a 12-hour overnight fast.
Baseline and Week 8.
Change in total cholesterol
Tidsramme: Baseline and Week 8.
Serum total cholesterol concentration (mg/dL).
Baseline and Week 8.
Change in LDL-cholesterol
Tidsramme: Baseline and Week 8.
Serum low-density lipoprotein cholesterol concentration (mg/dL).
Baseline and Week 8.
Change in HDL-cholesterol
Tidsramme: Baseline and Week 8.
Serum high-density lipoprotein cholesterol concentration (mg/dL).
Baseline and Week 8.
Change in triglycerides
Tidsramme: Baseline and Week 8.
Serum triglyceride concentration (mg/dL).
Baseline and Week 8.
Change in intestinal abundance of Bifidobacterium
Tidsramme: Baseline and Week 8.
Relative abundance of Bifidobacterium determined from fecal samples using 16S rRNA gene sequencing.
Baseline and Week 8.
Change in intestinal abundance of Lactobacillaceae
Tidsramme: Baseline and Week 8.
Relative abundance of Lactobacillaceae determined from fecal samples using 16S rRNA gene sequencing.
Baseline and Week 8.
Change in body weight
Tidsramme: Baseline and Week 8.
Body weight measured in kilograms using standardized procedures.
Baseline and Week 8.
Change in body mass index (BMI)
Tidsramme: Baseline and Week 8.
Body mass index calculated as weight (kg)/height (m²).
Baseline and Week 8.
Change in waist circumference
Tidsramme: Baseline and Week 8.
Waist circumference measured in centimeters using a non-elastic measuring tape.
Baseline and Week 8.
Change in body fat percentage
Tidsramme: Baseline and Week 8.
Body fat percentage assessed by bioelectrical impedance analysis.
Baseline and Week 8.
Change in muscle mass percentage
Tidsramme: Baseline and Week 8.
Muscle mass percentage assessed by bioelectrical impedance analysis.
Baseline and Week 8.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad Autonoma de Queretaro

Samarbejdspartnere

Instituto Nacional de Medicina Genomica

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2024

Primær færdiggørelse (Faktiske)

1. januar 2025

Studieafslutning (Anslået)

1. august 2026

Datoer for studieregistrering

Først indsendt

6. juli 2026

Først indsendt, der opfyldte QC-kriterier

6. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 011FCN2024
  • University (Anden identifikator: Universidad Autónoma de Querétaro)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Kliniske forsøg med Metabolisk syndrom

Kliniske forsøg med Maltodextrin (Placebo)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Japan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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