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

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ClinicalTrials.gov Identifier: NCT03928249
Recruitment Status : Not yet recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Thais Cesar, São Paulo State University

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 Intervention/treatment Phase
Pre Diabetes Dietary Supplement: Eriocitrin Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.


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.





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



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928249


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

Locations
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Brazil
Sao Paulo State University "Julio de Mesquita Filho" Not yet recruiting
Araraquara, São Paulo, Brazil, 14800-903
Contact: Thais B Cesar, Phd    +55 16 3301-6927    thais.cesar@unesp.br   
Sponsors and Collaborators
São Paulo State University
Investigators
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Principal Investigator: Thais B Cesar, Phd Sao Paulo State University "Julio de Mesquita Filho"

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Responsible Party: Thais Cesar, Principal Investigator, 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: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thais Cesar, São Paulo State University:
Eriocitrin
Citrus bioflavonoids
Flavanone
Pre-diabetes
Blood glucose

Additional relevant MeSH terms:
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Hyperglycemia
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases