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Supplementation of Eriocitrin in Intestinal Microbiota

NCT03925909 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-03-25

No results posted yet for this study

Summary

Pre-diabetes is characterized by high plasma concentration of glucose and glycated hemoglobin and is the main risk factor for the development of type 2 diabetes. Several studies show that the intestinal microbiota is intimately linked to cardio-metabolic factors (type 2 diabetes, insulin resistance) when in situations of dysbiosis. Food is a key element for a healthy microbiota, focusing on the consumption of polyphenols that modulate the intestinal environment through its alteration and production of short chain fatty acids, and can thus be a way of reversing situations such as pre- diabetes and insulin resistance. The objective of the study will be to investigate whether chronic supplementation of eriocitrin alters the intestinal microbiota of pre-diabetic and insulin resistant individuals, reversing these situations. This will be done by supplementation of eriocitrin-containing capsules with different dosages in pre-diabetic and insulin resistant individuals. There will be 12 weeks of intervention, with faecal collections, anthropometric and dietary evaluation, and then will be made microbiological analysis to identify the intestinal microbiota and biochemical analysis before and after the intervention. For statistical analysis, normality and homogeneity test (Kolmogorov-Smirnov and Levine test respectively), T-test to compare baseline time between groups and repeated-measures ANOVA (two-way) were used to compare changes within and between groups.

Conditions

  • Pre Diabetes

Interventions

DIETARY_SUPPLEMENT

Eriocitrin

The responsible nutritionists will do 1) Anthropometric Assessment, in which weight data will be collected (kg); height (m); waist circumference (cm), waist circumference (cm) and hip circumference (cm), muscle mass (kg /%) and percentage of fat by means of bioimpedance equipment; 2) Dietary assessment, which will be performed through a 24-hour Food Recall, a 3-day Food Record and a Food Consumption Frequency Questionnaire; 3) Evaluation of the microbiota, for which stool will be collected from the last 24 hours on the day before the beginning of the experiment and at the end of the study (week 12); 3) Biochemical evaluation, which includes the collection of 30 mL of blood to be performed by trained and qualified technicians.

Sponsors & Collaborators

  • São Paulo State University

    lead OTHER

Principal Investigators

  • Thais B Cesar, Phd · ao Paulo State University "Julio de Mesquita Filho"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2019-08-01
Completion
2020-03-23

Countries

  • Brazil

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 NCT03925909 on ClinicalTrials.gov