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Effect of Functional Foods on Gut Microbiota in Metabolic Syndrome

NCT03611140 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-08-02

No results posted yet for this study

Summary

Aim: To study the effect of a combination of functional foods on gut microbiota in subjects with metabolic syndrome. Subjects that met the metabolic syndrome criteria were enrolled in a double-blind, parallel-arm, placebo-control study. The subjects were randomized to receive a dietary portfolio (DP) or placebo (P) treatment for 2 mo. The primary endpoint was to study the effect of a DP on gut microbiota. Secondary endpoints were biochemical and anthropometric parameters, LPS, insulin, leptin, area under the curve for glucose and insulin.

Conditions

  • Metabolic Syndrome

Interventions

DIETARY_SUPPLEMENT

DP

a package containing a mix of functional foods

DIETARY_SUPPLEMENT

Placebo

a package containing maltodextrins and caseinate calcium to mimic the DP

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Nimbe y Torres, PhD · Instituto Nacional de Ciencias Médicas y Nutrición

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-01-10
Primary Completion
2018-06-15
Completion
2018-07-15

Countries

  • Mexico

Study Locations

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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 NCT03611140 on ClinicalTrials.gov