Clinical trial NCT03928249: Therapeutic Intervention of Eriocitrin in the Reduction of Hyperglycemia in Pre-diabetic Individuals
Official title: Therapeutic Intervention of Eriocitrin in Reducing Hyperglycemia in Pre-diabetic Subjects: Double-blind, Randomized, Placebo-controlled Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Diabetes
Keywords: Eriocitrin
Citrus bioflavonoids
Flavanone
Pre-diabetes
Blood glucose
Lead sponsor: São Paulo State University
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Supplementation with citrus bioflavonoids (hesperidin, naringin, diosmin and eriocitrin, among others) has been associated with an improvement in the glycidic and lipid profile, reduction of insulin resistance and systemic inflammation, and reduction of endothelial damage. This study aims to evaluate the effects of eriocitrin supplementation on the metabolic parameters of pre-diabetic individuals. Participants will be adults with pre-diabetes who will receive 200 mg / d of eriocitrin. Before, during and after treatment, anthropometric measures (weight, body composition and circumferences), biochemical (lipid and glucose profile, inflammatory parameters, endothelial markers, liver function, renal function) will be evaluated. Metabolic parameters that constitute risk factors for diabetes and associated chronic diseases are expected to be improved by supplementation with eriocitrin.

Detailed description: Individuals aged 35-60 years and who present at least one of the following criteria: (1) increased fasting blood glucose from 6.1 to 7.0 mmol / L, (2) decreased glucose tolerance of 7 , 8 to 11.1 mmol / L, and (3) glycated hemoglobin with values between 5.7 and 6.4% 10 will be eligible to participate in this study. The exclusion criteria will be to use hypoglycemic, hypolipidemic drugs, dietary supplements (vitamins, minerals, bioflavonoids, prebiotics, probiotics or other bioactive compounds), exercise intensely (more than 10 hours per week), history of cardiovascular diseases , diabetes mellitus, liver and kidney disease.

The selected individuals will be distributed randomly in 2 groups through random number generator program. Group A (n = 20) will receive 200 mg / d of eriocitrin for 12 weeks, with washout for 2 weeks and then receive 200 mg / d of placebo for 12 weeks; group B (n = 20) will receive 200 mg / d placebo for 12 weeks with washout for 2 weeks and then receive 200 mg / d placebo for 12 weeks.

The primary endpoint will be fasting blood glucose, blood glucose 2 hours after oral glucose tolerance test (GTTO), and HbA1c. The secondary endpoint will be insulin, HOMA-IR, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, ALP, yGT, AST, ALT, TNF-α, IL-6, CRP, body weight, body mass index BMI), muscle mass, fat mass, body fat and waist-hip ratio, and macronutrient intake.

Eligibility criteria: Inclusion Criteria:

* 35-60 years
* Increased fasting blood glucose from 6.1 to 7.0 mmol / L or,
* Decreased glucose tolerance of 7 , 8 to 11.1 mmol / L or,
* Glycated hemoglobin with values between 5.7 and 6.4%

Exclusion Criteria:

* Use hypoglycemic, hypolipidemic drugs,
* Use dietary supplements (vitamins, minerals, bioflavonoids, prebiotics, probiotics or other bioactive compounds),
* Exercise intensely (more than 10 hours per week)
* History of cardiovascular diseases , diabetes mellitus, liver and kidney disease.

Primary outcomes:
measure: Fasting glycemia
timeFrame: 0-12-18-26 week
Secondary outcomes:
measure: Rate of change in plasma glucose concentration
timeFrame: 0-12-18-26 week
measure: Rate of change in plasma HbA1c
timeFrame: 0-12-18-26 week
measure: Rate of change in plasma insulin concentration
timeFrame: 0-12-18-26 week
measure: Rate of change in plasma lipid concentration
timeFrame: 0-12-18-26 week
measure: Rate of change in plasma hepatic enzymes
timeFrame: 0-12-18-26 week
measure: Rate of change in plasma inflammatory parameters
timeFrame: 0-12-18-26 week
measure: Rate of change in anthropometric parameters
timeFrame: 0-12-18-26 week
Other outcomes:
Locations:
city: Araraquara
country: Brazil
facility: Sao Paulo State University "Julio de Mesquita Filho"
state: São Paulo
Study officials:
affiliation: Sao Paulo State University "Julio de Mesquita Filho"
name: Thais B Cesar, Phd
role: PRINCIPAL_INVESTIGATOR
References: