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Gastrointestinal Tolerability to Agavins and Impact on Host-gut Microbiota-metabolism Interactions Modulation

NCT04555447 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-09-18

No results posted yet for this study

Summary

Agavins are branched neo-fructans and prebiotic fiber found in Agave plants. In preclinical studies, agavins have demonstrated an effect in reversing metabolic disorders associated to overweight and obesity through the modulation of gut microbiota activity and composition, showing their interesting potential in the context of high obesity and cardiovascular diseases prevalence in Mexican population. However, current information about gastrointestinal adaptation and effects of agavins intake in humans is scarce. We hypothesized that increasing amounts of agavins up to 12 g/day, will be well tolerated by healthy and obese adult participants, but with differences between these groups, modulating gut microbiota activity and structure differentially, as well as the metabolic status after a 5-week dose-escalation intervention.

Conditions

Interventions

DIETARY_SUPPLEMENT

Agavins (prebiotic fiber)

Agavins contained in ready-to-use sachets were dissolved in water, and participants consumed the corresponding dose daily (2.5, 5.0, 7.0, 10 or 12 g) for 1 week, preferentially in the evening. Participants followed a 5-week dose-escalation intervention.

DIETARY_SUPPLEMENT

Placebo

Maltodextrin contained in ready-to-use sachets was dissolved in water, and participants consumed the corresponding dose daily (2.5, 5.0, 7.0, 10 or 12 g) for 1 week, preferentially in the evening. Participants followed a 5-week dose-escalation intervention.

Sponsors & Collaborators

  • Centro de Estudios Cardiometabólicos S.C. (CESCAM)

    collaborator UNKNOWN

  • Inulina y Miel de Agave S.A. de C.V. (IMAG)

    collaborator UNKNOWN

  • Centro De Investigación Y De Estudios Avanzados Del Instituto Politécnico Nacional-Unidad Irapuato

    lead OTHER

Principal Investigators

  • Mercedes G. López, PhD · Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional-UI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-22
Primary Completion
2019-09-07
Completion
2019-09-07

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04555447 on ClinicalTrials.gov