Clinical trial NCT03215043: Effect of Eriocitrin Supplementation in Subjects With Intermediate Hyperglycemia
Official title: Evaluation of Metabolic Parameters in Subjects With Intermediate Hyperglycemia Supplemented With Eriocitrin: A Parallel, Double-blind, Randomized, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Diabetes
Keywords: Eriocitrin
Intermediate hyperglycemia
Citrus bioflavonoids
Lead sponsor: São Paulo State University
Sponsor class: OTHER
Collaborators: name: Ingredients by Nature TM
First posted: 2017-07-12
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glucose
timeFrame: 12 Weeks
Secondary outcomes:
measure: glycated hemoglobin
timeFrame: 12 Weeks
measure: insulin
timeFrame: 12 Weeks
measure: Cholesterol
timeFrame: 12 Weeks
measure: triglycerides
timeFrame: 12 Weeks
measure: HDL-C
timeFrame: 12 Weeks
measure: LDL-C
timeFrame: 12 Weeks
measure: TNF-alpha
timeFrame: 12 Weeks
measure: Interleucina 6
timeFrame: 12 Weeks
measure: c-reactive protein
timeFrame: 12 Weeks
measure: aspartate aminotransferase
timeFrame: 12 Weeks
measure: alkaline phosphatase
timeFrame: 12 Weeks
measure: Gamma-Glutamyl Transferase
timeFrame: 12 Weeks
measure: alanine aminotransferase
timeFrame: 12 Weeks
Other outcomes:
measure: Body mass
timeFrame: 12 Weeks
measure: fat mass
timeFrame: 12 Weeks
measure: percentage of total body fat
timeFrame: 12 Weeks
measure: visceral fat area
timeFrame: 12 Weeks
Locations:
city: Araraquara
country: Brazil
facility: Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas
state: Sao Paulo
Study officials:
affiliation: Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas
name: Thais B Cesar, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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