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Therapeutic Intervention of Eriocitrin in the Reduction of Hyperglycemia in Pre-diabetic Individuals

NCT03928249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-10-23

No results posted yet for this study

Summary

Supplementation with citrus bioflavonoids (hesperidin, naringin, diosmin and eriocitrin, among others) has been associated with an improvement in the glycidic and lipid profile, reduction of insulin resistance and systemic inflammation, and reduction of endothelial damage. This study aims to evaluate the effects of eriocitrin supplementation on the metabolic parameters of pre-diabetic individuals. Participants will be adults with pre-diabetes who will receive 200 mg / d of eriocitrin. Before, during and after treatment, anthropometric measures (weight, body composition and circumferences), biochemical (lipid and glucose profile, inflammatory parameters, endothelial markers, liver function, renal function) will be evaluated. Metabolic parameters that constitute risk factors for diabetes and associated chronic diseases are expected to be improved by supplementation with eriocitrin.

Conditions

  • Pre Diabetes

Interventions

DIETARY_SUPPLEMENT

Eriocitrin

A crossover, double-blind, randomized, placebo-controlled clinical study with a duration of 26 weeks will be performed. All individuals and the principal investigator will remain blind to treatment until all analyzes are completed. Participants will be invited to attend 12-hour fasting to measure glucose levels, glycated hemoglobin and to perform the glucose tolerance test, in addition to an individual interview (Appendix B) to confirm eligibility according to the inclusion and exclusion criteria . The collection of blood and the glycemic curves will be performed at the beginning of the first, 12th, 14th and 26th week in the Laboratory of Clinical Analyzes ( Araraquara) At the beginning of the first, 12th, 14th and 26th week the following anthropometric parameters will be evaluated: body weight (kg), muscle mass (kg), fat mass (kg), body fat (%) (InBody 720, Biospace, Tokyo, Japan ) and waist-hip ratio.

Sponsors & Collaborators

  • São Paulo State University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2020-06-15
Completion
2020-10-22

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 NCT03928249 on ClinicalTrials.gov