Effect of Eriocitrin Supplementation in Subjects With Intermediate Hyperglycemia

Pre Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215043
• Other study ID #: SaoPSU7
• Status: Completed
• Phase: N/A
• Start date: July 2, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: August 2023
• Source: São Paulo State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia
• Pre Diabetes
• Prediabetic State

Intervention

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.

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.

Locations

Country	Name	City	State
Brazil	Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas	Araraquara	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Thais Cesar	Ingredients by Nature TM

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body mass	Kg	12 Weeks
Other	fat mass	kg	12 Weeks
Other	percentage of total body fat	Percentage	12 Weeks
Other	visceral fat area	cm2	12 Weeks
Primary	Glucose	mg/dL	12 Weeks
Secondary	glycated hemoglobin	percentage	12 Weeks
Secondary	insulin	µU/mL	12 Weeks
Secondary	Cholesterol	mg/dL	12 Weeks
Secondary	triglycerides	mg/dL	12 Weeks
Secondary	HDL-C	mg/dL	12 Weeks
Secondary	LDL-C	mg/dL	12 Weeks
Secondary	TNF-alpha	pg.mL	12 Weeks
Secondary	Interleucina 6	pg.mL	12 Weeks
Secondary	c-reactive protein	mg/dL	12 Weeks
Secondary	aspartate aminotransferase	U/L	12 Weeks
Secondary	alkaline phosphatase	U/L	12 Weeks
Secondary	Gamma-Glutamyl Transferase	U/L	12 Weeks
Secondary	alanine aminotransferase	U/L	12 Weeks

External Links

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