Effect of Eriocitrin Supplementation in Subjects With Intermediate Hyperglycemia

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

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

Study Overview

• Status: Completed
• Conditions: Pre Diabetes
• Intervention / Treatment: Dietary supplement: Eriocitrin; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Araraquara, Sao Paulo, Brazil, 14800-903
      • Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 59 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass	Kg	12 Weeks
fat mass	kg	12 Weeks
percentage of total body fat	Percentage	12 Weeks
visceral fat area	cm2	12 Weeks

Collaborators and Investigators

• Sponsor: Thais Cesar
• Collaborators: Ingredients by Nature TM
• Investigators: Principal Investigator: Thais B Cesar, Ph.D, Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas

Publications and helpful links

General Publications

• Mohammad M, et al. Effects of Hesperidin Supplementation on Glycemic Control, Lipid Profile and Inflammatory Markers in Patients with Type 2 Diabetes: A Randomized Double Blind Placebo Control Clinical Trial. Research Article, Acta Biologica Indica 2015, 4(1):75-83. ISSN 2279-0160

Helpful Links

• WHO, 2006 - Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia.

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: July 11, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Eriocitrin; Citrus bioflavonoids; Intermediate hyperglycemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State
• Other Study ID Numbers: SaoPSU7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There is still no decision regarding if the individual participant data (IPD) will be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No