Therapeutic Intervention of Eriocitrin in the Reduction of Hyperglycemia in Pre-diabetic Individuals
- Conditions
- Pre Diabetes
- Interventions
- Dietary Supplement: Eriocitrin
- Registration Number
- NCT03928249
- Lead Sponsor
- São Paulo State University
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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%
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Grupo A Eriocitrin 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 GRUPO B Eriocitrin 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
- Primary Outcome Measures
Name Time Method Fasting glycemia 0-12-18-26 week Changes in serum glycemia concentration before and after administration of the intervention/placebo
- Secondary Outcome Measures
Name Time Method Rate of change in plasma hepatic enzymes 0-12-18-26 week Changes in ALT (U/L), AST (U/L), ALP (U/L), GGT (U/L) before and after administration of the intervention / placebo
Rate of change in plasma insulin concentration 0-12-18-26 week Changes in serum insulin (µU/mL) before and after administration of the intervention / placebo
Rate of change in plasma HbA1c 0-12-18-26 week Changes in serum HbA1c (%) before and after administration of the intervention / placebo
Rate of change in plasma inflammatory parameters 0-12-18-26 week Changes in CRP (mg/dL), TNF-a (mg/dL), IL-6 (mg/dL) before and after administration of the intervention / placebo
Rate of change in plasma lipid concentration 0-12-18-26 week 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
Rate of change in plasma glucose concentration 0-12-18-26 week Changes in serum 2 hours after oral glucose tolerance test (mg/dL) before and after administration of the intervention / placebo
Rate of change in anthropometric parameters 0-12-18-26 week Changes in body weight (Kg), muscle mass (Kg), fat mass (Kg) before and after administration of the intervention / placebo
Trial Locations
- Locations (1)
Sao Paulo State University "Julio de Mesquita Filho"
🇧🇷Araraquara, São Paulo, Brazil