Therapeutic Intervention of Eriocitrin in the Reduction of Hyperglycemia in Pre-diabetic Individuals
Condition: Pre Diabetes
MeSH terms: Hyperglycemia; Prediabetic State; Glucose Intolerance
Study type: Interventional

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.
    

Intervention name(s): Eriocitrin
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eriocitrin; Citrus bioflavonoids; Flavanone; Pre-diabetes; Blood glucose