Effect of Eriocitrin Supplementation in Subjects With Intermediate Hyperglycemia
Condition: Pre Diabetes
MeSH terms: Hyperglycemia; Prediabetic State
Study type: Interventional

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
    

Detailed description: 
      Volunteers will be invited to appear in a 12-hour fast to measure glucose levels, glycated
      hemoglobin and to perform the glucose tolerance test, in addition to an individual interview
      to confirm eligibility according to the inclusion and exclusion criteria. The collection of
      blood and the glycemic curves will be carried out next to a Laboratory of Clinical Analyzes,
      commercial, based in the city of Araraquara.

      The sample number took into account variances on glycated hemoglobin with a type I error α =
      0.05 and a type II error β = 0.2 (80% power) (Mohammad, 2015). The minimum sample size
      considering an approximately 20% dropout rate, should have 20 individuals per group.

      In order to ensure adequate nutrition for the nutritional and energetic needs of volunteers,
      an individual food plan shall be prescribed, calculated according to the DRI equations. The
      volunteer will be asked to complete the Food Record for three days at the 3rd, 5th, 7th, 9th
      and 11th week. Data analysis of energy intake, macronutrients and micronutrients will be
      performed through the DietBox® . The anthropometric measurements will be performed before the
      intervention and in the 3rd, 5th, 7th, 9th and 11th week by Nutritionist. Four samples of
      30mL of fasting blood each will be obtained before the intervention, in the 4th, 8th and 12th
      week in the Laboratory of Clinical Analyzes. The blood will be centrifuged to obtain the
      serum, which will be frozen at -80 ° C until subsequent biochemical analyzes.

      Normality and homogeneity will be evaluated by Shapiro-Wilk test and Levine tests,
      respectively. The T test will be used to compare baseline time between groups. The two-way
      repeated-measures ANOVA will be used to compare changes within and between the eriocitrin and
      control groups over the 12-week period. P significant at ≤ 0.05.
    

Intervention name(s): Eriocitrin; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eriocitrin; Intermediate hyperglycemia; Citrus bioflavonoids