MedTrace Logo

Effect of Eriocitrin Supplementation in Subjects With Intermediate Hyperglycemia

NCT03215043 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-09-01

No results posted yet for this study

Summary

First, it will be evaluated whether supplementation of eriocitrin reduces hyperglycemia and insulin resistance, significantly reducing the risk of diabetes. The effects of eriocitrin on the lipid profile, inflammatory, endothelial, hepatic and renal biomarkers will also be evaluated. It is expected that 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

The selected individuals will be randomly distributed in 4 groups through random number generator program. Group A (n = 20) will receive a dose of 140 mg / d eriocitrin; Group B (n = 20) eriocitrin 280 mg / d; The C group (n = 20) 560 mg / d eriocitrin; And group D (n = 20) will receive the placebo with corn starch excipient. All doses will be packaged in Manipulation Pharmacy, and should be of the same type, color and size. Individuals will be instructed to regularly ingest a pre-dinner capsule for 12 weeks.

OTHER

Placebo

The selected individuals will be randomly distributed in 4 groups through random number generator program. Group A (n = 20) will receive a dose of 140 mg / d eriocitrin; Group B (n = 20) eriocitrin 280 mg / d; The C group (n = 20) 560 mg / d eriocitrin; And group D (n = 20) will receive the placebo with corn starch excipient. All doses will be packaged in Manipulation Pharmacy, and should be of the same type, color and size. Individuals will be instructed to regularly ingest a pre-dinner capsule for 12 weeks.

Sponsors & Collaborators

  • Ingredients by Nature TM

    collaborator UNKNOWN

  • Thais Cesar

    lead OTHER

Principal Investigators

  • Thais B Cesar, Ph.D · Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-07-02
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT03215043 on ClinicalTrials.gov