An interventional study of Eriocitrin and Placebo in Pre Diabetes, sponsored by Thais Cesar. Completed at 1 site in Brazil. Open to participants aged 30 Years to 59 Years. Per ClinicalTrials.gov, last updated 2023-09-01.
Sponsored by Thais Cesar · Not applicable, Interventional, and Treatment
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
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.
792 studies on the registry are indexed under Glucose Intolerance; 126 are open to participants now.
This study's enrollment of 120 is above the median of 60 across 656 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →Thais Cesar is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Individuals will receive a dose of 140 mg / d eriocitrin for 12 weeks
Dietary Supplement: Eriocitrin
Individuals will receive a dose of 280 mg / d eriocitrin for 12 weeks
Dietary Supplement: Eriocitrin
Individuals will receive a dose of 560 mg / d eriocitrin for 12 weeks
Dietary Supplement: Eriocitrin
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.
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.
Glucose
mg/dL
Time frame: 12 Weeks
glycated hemoglobin
percentage
Time frame: 12 Weeks
insulin
µU/mL
Time frame: 12 Weeks
Cholesterol
mg/dL
Time frame: 12 Weeks
triglycerides
mg/dL
Time frame: 12 Weeks
HDL-C
mg/dL
Time frame: 12 Weeks
LDL-C
mg/dL
Time frame: 12 Weeks
TNF-alpha
pg.mL
Time frame: 12 Weeks
Interleucina 6
pg.mL
Time frame: 12 Weeks
c-reactive protein
mg/dL
Time frame: 12 Weeks
aspartate aminotransferase
U/L
Time frame: 12 Weeks
alkaline phosphatase
U/L
Time frame: 12 Weeks
Gamma-Glutamyl Transferase
U/L
Time frame: 12 Weeks
alanine aminotransferase
U/L
Time frame: 12 Weeks
Body mass
Kg
Time frame: 12 Weeks
fat mass
kg
Time frame: 12 Weeks
percentage of total body fat
Percentage
Time frame: 12 Weeks
visceral fat area
cm2
Time frame: 12 Weeks
Plan to share: Undecided — There is still no decision regarding if the individual participant data (IPD) will be available to other researchers.
Ran from Jul 2017 to primary completion in Feb 2018, 7 months.
Of 271 non-industry interventional studies with no phase under Glucose Intolerance, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 7 months is below that.
Counting every sponsor, half of 304 studies reached it within 24 months; a quarter within 10 and three quarters within 44.
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Eriocitrin
Thais Cesar