At a glance

ClinicalIndex Comparison Record

N/ACompleted· 81 enrolled

Drug / intervention

dietary portfoliodietary

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/NCT03421301

NCT03421301N/ACompleted

Compare CT.gov

A Dietary Intervention With Functional Foods Reduce Metabolic Endotoxemia and Attenuates Biochemical Abnormalities in Subjects With Type 2 Diabetes by Modifying the Gut Microbiota.

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·interventional·Posted Feb 5, 2018·Updated Feb 5, 2018

In Brief

A clinical study evaluating dietary portfolio for Type 2 Diabetes Mellitus. Completed, enrolled 81 participants.

Detailed Summary

Aim: To study the effect of a dietary intervention with functional foods on gut microbiota in subjects with type 2 diabetes Materials and methods: Patients with type 2 diabetes were enrolled in a double-blind, parallel-arm, placebo-control study were randomized to receive a dietary portfolio (DP) or placebo (P) treatment for 3 mo. The primary endpoint was the effect of a dietary portfolio based on functional foods on gut microbiota. Secondary endpoints were biochemical parameters, branched chain amino acids, TMAO

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsType 2 Diabetes Mellitus

Countries--

CollaboratorsUniversity of Connecticut

Timeline

N/ACompletedFinished

201520162017201820192020202120222023202420252026

Enrollment StartAug 2014

Primary CompletionSep 2016

Study CompletionDec 2016

First PostedFeb 2018

TodayJul 2026

First PostedFeb 5, 2018

Enrollment StartAug 7, 2014

Primary CompletionSep 28, 2016

Study CompletionDec 28, 2016

TodayJul 2, 2026

Enrollment to primary: 2.1 yearsPosted 8.4 years ago

Interventions

dietary portfoliodietary

The dietary intervention was a combination of functional foods (dehydrated nopal, chia seed, soy protein and inulin) that was provided in dehydrated form in packages of 17.3 g dissolved in 250 ml water for breakfast and 34.7 g in 300 ml water for dinner.