Effect of Eriocitrin Supplementation in Subjects With Intermediate Hyperglycemia

Not Applicable

Completed

• Conditions: Pre Diabetes
• Interventions: Dietary Supplement: Eriocitrin; Other: Placebo

• Registration Number: NCT03215043
• Lead Sponsor: Thais Cesar

Brief 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.

Study Timeline

• Study Start: 2017-07-02
• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-12
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Eriocitrin	Individuals will receive a dose of 560 mg / d eriocitrin for 12 weeks
Group D	Placebo	Individuals will receive the placebo with corn starch excipient for 12 weeks
Group A	Eriocitrin	Individuals will receive a dose of 140 mg / d eriocitrin for 12 weeks
Group B	Eriocitrin	Individuals will receive a dose of 280 mg / d eriocitrin for 12 weeks

Primary Outcome Measures

Name	Time	Method
Glucose	12 Weeks	mg/dL

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas; 🇧🇷 Araraquara, Sao Paulo, Brazil