Group A (n = 20) will receive 200 mg / d of eriocitrin for 12 weeks, washout for 2 weeks and then receive 200 mg / d of placebo for 12 weeks

group B (n = 20) will receive 200 mg / d placebo for 12 weeks with washout for 2 weeks and then receive 200 mg / d placebo for 12 weeks

Pre Diabetes

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.

Eriocitrin

Sao Paulo State University "Julio de Mesquita Filho"

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

Therapeutic Intervention of Eriocitrin in Reducing Hyperglycemia in Pre-diabetic Subjects: Double-blind, Randomized, Placebo-controlled Crossover Clinical Trial

Changes in serum glycemia concentration before and after administration of the intervention/placebo

Changes in serum 2 hours after oral glucose tolerance test (mg/dL) before and after administration of the intervention / placebo

Changes in serum HbA1c (%) before and after administration of the intervention / placebo

Changes in serum insulin (µU/mL) before and after administration of the intervention / placebo

Changes in serum cholesterol (mg/dL), triglycerides (mg/dL),HDL-C(mg/dL), LDL-C(mg/dL) before and after administration of the intervention/placebo

Changes in ALT (U/L), AST (U/L), ALP (U/L), GGT (U/L) before and after administration of the intervention / placebo

Changes in CRP (mg/dL), TNF-a (mg/dL), IL-6 (mg/dL) before and after administration of the intervention / placebo

Changes in body weight (Kg), muscle mass (Kg), fat mass (Kg) before and after administration of the intervention / placebo

Thais Cesar

Principal Investigator

São Paulo State University

Individuals will receive a dose of 140 mg / d eriocitrin for 12 weeks

Individuals will receive a dose of 280 mg / d eriocitrin for 12 weeks

Individuals will receive a dose of 560 mg / d eriocitrin for 12 weeks

Individuals will receive the placebo with corn starch excipient for 12 weeks

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.

Placebo

WHO, 2006 - Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia.

Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas

Effect of Eriocitrin Supplementation in Subjects With Intermediate Hyperglycemia

Evaluation of Metabolic Parameters in Subjects With Intermediate Hyperglycemia Supplemented With Eriocitrin: A Parallel, Double-blind, Randomized, Placebo-controlled Clinical Trial

There is still no decision regarding if the individual participant data (IPD) will be available to other researchers.

eriocitrin/i̇ltihab

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

Effect of Eriocitrin Supplementation in Subjects With Intermediate Hyperglycemia

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