CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
DP +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03611140
NCT03611140N/ACompleted
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Effect of a Dietary Portfolio (PD) (Nopal, Chia, Soy, Oat and Inulin) and Physical Activity on Gut Microbiota in Patients With Metabolic Syndrome

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·interventional·Posted Aug 2, 2018·Updated Aug 2, 2018

In Brief

A clinical study evaluating DP and Placebo for Metabolic Syndrome. Completed, enrolled 72 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolic Syndrome
CountriesMexico
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 2, 2018
Enrollment StartJan 10, 2014
Primary CompletionJun 15, 2018
Study CompletionJul 15, 2018
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 7.9 years ago

Interventions

DPdietary

a package containing a mix of functional foods

Placebodietary

a package containing maltodextrins and caseinate calcium to mimic the DP