Effect of Eriocitrin Supplementation in Subjects With Intermediate Hyperglycemia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pre Diabetes

Intervention / Treatment
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* Dietary Supplement: Eriocitrin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Glycemia of 6.1 to 7.0 mmol / L Glycated hemoglobin with values between 5.7 and 6.4% Exclusion Criteria: use of drugs, vitamins and dietary supplements, alcohol consumption (> 20 g alcohol/d), and intense physical activity (> 5 hours/week). History of cardiovascular disease, diabetes mellitus, liver or kidney disease

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Individuals will receive a dose of 140 mg / d eriocitrin for 12 weeks | Dietary Supplement: Eriocitrin<br>* 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.<br>|
| Experimental: Group B<br>Individuals will receive a dose of 280 mg / d eriocitrin for 12 weeks | Dietary Supplement: Eriocitrin<br>* 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.<br>|
| Experimental: Group C<br>Individuals will receive a dose of 560 mg / d eriocitrin for 12 weeks | Dietary Supplement: Eriocitrin<br>* 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.<br>|
| Placebo Comparator: Group D<br>Individuals will receive the placebo with corn starch excipient for 12 weeks | Other: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose | mg/dL | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycated hemoglobin | percentage | 12 Weeks | 
| insulin | µU/mL | 12 Weeks | 
| Cholesterol | mg/dL | 12 Weeks | 
| triglycerides | mg/dL | 12 Weeks | 
| HDL-C | mg/dL | 12 Weeks | 
| LDL-C | mg/dL | 12 Weeks | 
| TNF-alpha | pg.mL | 12 Weeks | 
| Interleucina 6 | pg.mL | 12 Weeks | 
| c-reactive protein | mg/dL | 12 Weeks | 
| aspartate aminotransferase | U/L | 12 Weeks | 
| alkaline phosphatase | U/L | 12 Weeks | 
| Gamma-Glutamyl Transferase | U/L | 12 Weeks | 
| alanine aminotransferase | U/L | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eriocitrin, Intermediate hyperglycemia, Citrus bioflavonoids