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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

Therapeutic Intervention of Eriocitrin in the Reduction of Hyperglycemia in Pre-diabetic Individuals

Clinicaltrials.gov identifier NCT03928249

Recruitment Status Recruiting

First Posted April 26, 2019

Last update posted March 25, 2020

Study Description

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.

  • Condition or Disease:Pre Diabetes
  • Intervention/Treatment: Dietary Supplement: Eriocitrin
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Therapeutic Intervention of Eriocitrin in Reducing Hyperglycemia in Pre-diabetic Subjects: Double-blind, Randomized, Placebo-controlled Crossover Clinical Trial
  • Actual Study Start Date: December 2019
  • Estimated Primary Completion Date: June 2020
  • Estimated Study Completion Date: February 2021
Arms and interventions
Arm Intervention/treatment
Placebo Comparator: GRUPO B
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
Dietary Supplement: Eriocitrin
A crossover, double-blind, randomized, placebo-controlled clinical study with a duration of 26 weeks will be performed. All individuals and the principal investigator will remain blind to treatment until all analyzes are completed. Participants will be invited to attend 12-hour fasting to measure glucose levels, glycated hemoglobin and to perform the glucose tolerance test, in addition to an individual interview (Appendix B) to confirm eligibility according to the inclusion and exclusion criteria . The collection of blood and the glycemic curves will be performed at the beginning of the first, 12th, 14th and 26th week in the Laboratory of Clinical Analyzes ( Araraquara) At the beginning of the first, 12th, 14th and 26th week the following anthropometric parameters will be evaluated: body weight (kg), muscle mass (kg), fat mass (kg), body fat (%) (InBody 720, Biospace, Tokyo, Japan ) and waist-hip ratio.
Active Comparator: Grupo A
Group A (n = 20) will receive 200 mg / d of eriocitrin for 12 weeks, washout for 2 weeks and then receive 200 mg / d of placebo for 12 weeks
Dietary Supplement: Eriocitrin
A crossover, double-blind, randomized, placebo-controlled clinical study with a duration of 26 weeks will be performed. All individuals and the principal investigator will remain blind to treatment until all analyzes are completed. Participants will be invited to attend 12-hour fasting to measure glucose levels, glycated hemoglobin and to perform the glucose tolerance test, in addition to an individual interview (Appendix B) to confirm eligibility according to the inclusion and exclusion criteria . The collection of blood and the glycemic curves will be performed at the beginning of the first, 12th, 14th and 26th week in the Laboratory of Clinical Analyzes ( Araraquara) At the beginning of the first, 12th, 14th and 26th week the following anthropometric parameters will be evaluated: body weight (kg), muscle mass (kg), fat mass (kg), body fat (%) (InBody 720, Biospace, Tokyo, Japan ) and waist-hip ratio.
Outcome Measures
  • Primary Outcome Measures: 1. Fasting glycemia [ Time Frame: 0-12-18-26 week ]
    Changes in serum glycemia concentration before and after administration of the intervention/placebo
  • Secondary Outcome Measures: 1. Rate of change in plasma glucose concentration [ Time Frame: 0-12-18-26 week ]
    Changes in serum 2 hours after oral glucose tolerance test (mg/dL) before and after administration of the intervention / placebo
  • 2. Rate of change in plasma HbA1c [ Time Frame: 0-12-18-26 week ]
    Changes in serum HbA1c (%) before and after administration of the intervention / placebo
  • 3. Rate of change in plasma insulin concentration [ Time Frame: 0-12-18-26 week ]
    Changes in serum insulin (µU/mL) before and after administration of the intervention / placebo
  • 4. Rate of change in plasma lipid concentration [ Time Frame: 0-12-18-26 week ]
    Changes in serum cholesterol (mg/dL), triglycerides (mg/dL),HDL-C(mg/dL), LDL-C(mg/dL) before and after administration of the intervention/placebo
  • 5. Rate of change in plasma hepatic enzymes [ Time Frame: 0-12-18-26 week ]
    Changes in ALT (U/L), AST (U/L), ALP (U/L), GGT (U/L) before and after administration of the intervention / placebo
  • 6. Rate of change in plasma inflammatory parameters [ Time Frame: 0-12-18-26 week ]
    Changes in CRP (mg/dL), TNF-a (mg/dL), IL-6 (mg/dL) before and after administration of the intervention / placebo
  • 7. Rate of change in anthropometric parameters [ Time Frame: 0-12-18-26 week ]
    Changes in body weight (Kg), muscle mass (Kg), fat mass (Kg) before and after administration of the intervention / placebo
Eligibility Criteria
  • Ages Eligible for Study: 35 to 60 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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.

Contacts and Locations
Contacts

Contact: Thais B Cesar, Phd +55 16 3301-6927 thais.cesar@unesp.br

Locations

Brazil, São Paulo
Sao Paulo State University "Julio de Mesquita Filho"
Araraquara

Sponsors and Collaborators

São Paulo State University

Investigators

Principal Investigator: Thais B Cesar, Phd Sao Paulo State University "Julio de Mesquita Filho"

More Information
  • Responsible Party: São Paulo State University
  • ClinicalTrials.gov Identifier: NCT03928249 History of Changes
  • Other Study ID Numbers: SaoPSU12
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: March 25, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by São Paulo State University: Citrus bioflavonoids
    Flavanone
    Pre-diabetes
    Blood glucose
    Eriocitrin
  • Additional relevant MeSH terms: Hyperglycemia
    Prediabetic State
    Glucose Intolerance