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

S

São Paulo State University

Status

Completed

Conditions

Pre Diabetes

Treatments

Dietary Supplement: Eriocitrin

Study type

Interventional

Funder types

Other

Identifiers

NCT03928249
SaoPSU12

Details and patient eligibility

About

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.

Full description

Individuals aged 35-60 years and who present at least one of the following criteria: (1) increased fasting blood glucose from 6.1 to 7.0 mmol / L, (2) decreased glucose tolerance of 7 , 8 to 11.1 mmol / L, and (3) glycated hemoglobin with values between 5.7 and 6.4% 10 will be eligible to participate in this study. The exclusion criteria will be to use hypoglycemic, hypolipidemic drugs, dietary supplements (vitamins, minerals, bioflavonoids, prebiotics, probiotics or other bioactive compounds), exercise intensely (more than 10 hours per week), history of cardiovascular diseases , diabetes mellitus, liver and kidney disease.

The selected individuals will be distributed randomly in 2 groups through random number generator program. Group A (n = 20) will receive 200 mg / d of eriocitrin for 12 weeks, with 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.

The primary endpoint will be fasting blood glucose, blood glucose 2 hours after oral glucose tolerance test (GTTO), and HbA1c. The secondary endpoint will be insulin, HOMA-IR, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, ALP, yGT, AST, ALT, TNF-α, IL-6, CRP, body weight, body mass index BMI), muscle mass, fat mass, body fat and waist-hip ratio, and macronutrient intake.

Enrollment

40 patients

Sex

All

Ages

35 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 35-60 years
  • Increased fasting blood glucose from 6.1 to 7.0 mmol / L or,
  • Decreased glucose tolerance of 7 , 8 to 11.1 mmol / L or,
  • Glycated hemoglobin with values between 5.7 and 6.4%

Exclusion criteria

  • Use hypoglycemic, hypolipidemic drugs,
  • Use dietary supplements (vitamins, minerals, bioflavonoids, prebiotics, probiotics or other bioactive compounds),
  • Exercise intensely (more than 10 hours per week)
  • History of cardiovascular diseases , diabetes mellitus, liver and kidney disease.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

40 participants in 2 patient groups, including a placebo group

Grupo A
Active Comparator group
Description:
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
Treatment:
Dietary Supplement: Eriocitrin
GRUPO B
Placebo Comparator group
Description:
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
Treatment:
Dietary Supplement: Eriocitrin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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