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出境医 / 临床实验 / Effect of Ellagic Ácid on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Effect of Ellagic Ácid on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Study Description
Brief Summary:
Metabolic syndrome (MS) is a group of important cardiovascular risk factors: abdominal obesity, dyslipidemia, hyperglycemia, and high blood pressure. Treatment requires the introduction of pharmacological management that includes different medications for each component. Ellagic acid (EA) is a polyphenol that has shown health benefits in multiple experimental studies. AE is consumed by patients without a prescription; considering there aren't studies that demonstrate it's effectiveness on MS, it is important to evaluate the possible effects of AE on this pathology. METHODOLOGY: Current study is a double-blind, placebo-controlled clinical trial. The aim of this study is evaluating the effect of AE on the components of metabolic syndrome, insulin sensitivity, and insulin secretion.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Ellagic Acid / Pomegranate Extract Drug: Placebo oral capsule Phase 2

Detailed Description:
INTRODUCTION: Ellagic acid (EA) is a polyphenol that has shown health benefits in multiple experimental studies; mainly as an antioxidant, but also in hepatic steatosis, endothelial damage, hypertension, diabetes mellitus, visceral fat accumulation, dyslipidemia, insulin resistance, atherosclerosis, etc. There aren't studies that demonstrate the effectiveness of EA on MS; and since it is consumed by patients without any prescription, it is important to evaluate the effect of the administration of EA on the components of metabolic syndrome, insulin sensitivity, and insulin secretion. The current design is a randomized double-blind, placebo-controlled, clinical trial. METHODS: Male and female volunteers between 31 to 60 years of age, with MS diagnosis of MS according to the criteria of the International Diabetes Federation will be included, whether they accept participating and signing the informed consent. Patients with one or more of the following criteria will be excluded: History of liver, kidney, heart, or thyroid disease; systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, fasting blood glucose: ≥126 mg / dL, triglycerides ≥400 mg / dL, LDL cholesterol > 190 mg / dL; pregnancy or lactation; consumption of medications or supplements which interact with EA or that have effects on any of the components of the MS. Patients included, may be withdrawn from the study if they meet any of the following conditions: Withdrawal of the informed consent; compliance with some exclusion criteria during the study; treatment adherence <80%; intolerance to EC or placebo. OBJECTIVES: Main objectives are measuring and comparing before and after the intervention, the effect of EA or placebo on metabolic syndrome components, insulin sensitivity, and insulin secretion. HEADQUARTERS: The study will be carried out in the facilities of the Institute of Experimental and Clinical Therapeutics (INTEC), of the University Center of Health Sciences, in the University of Guadalajara. Guadalajara, Jalisco, Mexico.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, placebo-controlled clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: randomized double-blind
Primary Purpose: Treatment
Official Title: Effect of Ellagic Acid Administration on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 2022
Arms and Interventions
Arm Intervention/treatment
Placebo Comparator: Placebo
16 patients to receive 1 homologated placebo capsule (calcinated magnesia 500 mg) every 12 hours along 12 weeks
 Drug: Placebo oral capsule
Calcinated magnesia in 500mg capsules. Homologated to the other intervention. Dosage twice a day orally every 12 hours during 12 weeks
Other Name: calcinated magnesia
Experimental: Ellagic acid
16 patients to receive 1 homologated intervention capsule (ellagic acid 500 mg) every 12 hours along 12 weeks
 Drug: Ellagic Acid / Pomegranate Extract
Phenolic acid, ellagitannin, found in a wide variety of fruits and nuts; in this particular case, pomegranate extract with ellagic acid 90% 500mg capsules. Homologated to the other intervention. Dosage twice a day orally every 12 hours during 12 weeks
Other Name: benzoaric acid
Outcome Measures
Primary Outcome Measures :
  1. waist circunference [ Time Frame: baseline to week 12 (end of intervention) ]
    Main criteria for metabolic syndrome diagnosis

  2. blood pressure [ Time Frame: baseline to week 12 (end of intervention) ]
    systolic blood pressure and diastolyc blood pressure by digital blood pressure monitor

  3. fasting blood glucose [ Time Frame: baseline to week 12 (end of intervention) ]
    fasting blood glucose by enzimatic-colorimetric automatized technique

  4. Fasting blood triglycerides concentration [ Time Frame: baseline to week 12 (end of intervention) ]
    fasting blood triglycerides by enzimatic-colorimetric automatized technique

  5. Fasting blood C-HDL concentration [ Time Frame: baseline to week 12 (end of intervention) ]
    fasting blood high density lypoprotein-cholesterol by enzimatic-colorimetric automatized technique

  6. Insulin sensitivity [ Time Frame: baseline to week 12 (end of intervention) ]
    From an oral glucose tolerance test with glucose 75g intake, and each 30 minutes sampling to get insulin and glucose levels; minuted glucose and insulin results will be analized with Matsuda Index to get insulin sensitivity

  7. Insulin secretion [ Time Frame: baseline to week 12 (end of intervention) ]
    Stumvoll and insulinogenic indexes will be used to calculating first-phase and total insulin secretion


Secondary Outcome Measures :
  1. body weight [ Time Frame: baseline to week 12 (end of intervention) ]
    body weight measured by bioelectrical impedance scale

  2. body mass index [ Time Frame: baseline to week 12 (end of intervention) ]
    body mass index (BMI) will be calculated with the Quetelet index formula

  3. body fat mass [ Time Frame: baseline to week 12 (end of intervention) ]
    body fat will be estimated by bioelectrical impedance analysis

  4. total cholesterol [ Time Frame: baseline to week 12 (end of intervention) ]
    fasting blood total cholesterol by enzimatic-colorimetric automatized technique

  5. Fasting blood C-LDL concentration [ Time Frame: baseline to week 12 (end of intervention) ]
    fasting blood low-density lipoprotein- cholesterol by enzimatic-colorimetric automatized technique

  6. Fasting blood VLDL concentration [ Time Frame: baseline to week 12 (end of intervention) ]
    fasting blood very low-density lipoprotein by enzimatic-colorimetric automatized technique

  7. Concentration of blood AST and ALT [ Time Frame: baseline / week 12 (end of intervention) ]
    aminotransferases by enzimatic-colorimetric automatized technique

  8. Concentration of blood uric acid [ Time Frame: baseline to week 12 (end of intervention) ]
    fasting blood uric acid by enzimatic-colorimetric automatized technique

  9. Concentration of blood creatinine [ Time Frame: baseline / week 12 (end of intervention) ]
    creatinine by enzimatic-colorimetric automatized technique

  10. Incidence of Treatment-Emergent Adverse Events [ Time Frame: baseline to week 12 (continuous surveillance) ]
    Incidence of placebo or ellagic acid, emergent adverse events will be identified by clinical evaluation


Eligibility Criteria
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Ages Eligible for Study:   31 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metabolic Syndrome diagnosis based on IDF criteria
  • Acceptance and signing of Informed Consent

Exclusion Criteria:

  • Knew kidney, liver, heart or thyroid disease
  • Systolic blood pressure ≥140 mmHg
  • Diastolic blood pressure ≥90 mmHg
  • Fast blood glucose ≥126 mg/dL
  • TG ≥400 mg/dL
  • C-LDL > 190 mg/dL
  • BMI: ≥35 kg/m2
  • Pregnancy or lactation period
  • Knew pomegranate allergy
  • Habitual warfarin, tolbutamide or carbamazepin consumption
  • Effect on any component of metabolic syndrome drugs or suplements regular intake
Contacts and Locations

Contacts
Layout table for location contacts
Contact: KARINA G PÉREZ-RUBIO, PhD +523310585200 ext 34212 karina2410@hotmail.com
Contact: MANUEL GONZÁLEZ-ORTIZ, PhD +523310585200 ext 34212 uiec@prodigy.net.mx

Locations
Layout table for location information
Mexico
INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud Recruiting
Guadalajara, Jalisco, Mexico, 44340
Contact: Karina G Pérez-Rubio, PhD    +523310585200 ext 34212    karina2410@hotmail.com   
Contact: Manuel González-Ortiz, PhD    +523310585200 ext 34212    uiec@prodigy.net.mx   
Sponsors and Collaborators
University of Guadalajara
National Council of Science and Technology, Mexico
Investigators
Layout table for investigator information
Principal Investigator: KARINA G PÉREZ-RUBIO, PhD University of Guadalajara
Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date November 17, 2020
Actual Study Start Date  ICMJE September 17, 2019
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
  • waist circunference [ Time Frame: baseline to week 12 (end of intervention) ]
    Main criteria for metabolic syndrome diagnosis
  • blood pressure [ Time Frame: baseline to week 12 (end of intervention) ]
    systolic blood pressure and diastolyc blood pressure by digital blood pressure monitor
  • fasting blood glucose [ Time Frame: baseline to week 12 (end of intervention) ]
    fasting blood glucose by enzimatic-colorimetric automatized technique
  • Fasting blood triglycerides concentration [ Time Frame: baseline to week 12 (end of intervention) ]
    fasting blood triglycerides by enzimatic-colorimetric automatized technique
  • Fasting blood C-HDL concentration [ Time Frame: baseline to week 12 (end of intervention) ]
    fasting blood high density lypoprotein-cholesterol by enzimatic-colorimetric automatized technique
  • Insulin sensitivity [ Time Frame: baseline to week 12 (end of intervention) ]
    From an oral glucose tolerance test with glucose 75g intake, and each 30 minutes sampling to get insulin and glucose levels; minuted glucose and insulin results will be analized with Matsuda Index to get insulin sensitivity
  • Insulin secretion [ Time Frame: baseline to week 12 (end of intervention) ]
    Stumvoll and insulinogenic indexes will be used to calculating first-phase and total insulin secretion
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
  • body weight [ Time Frame: baseline to week 12 (end of intervention) ]
    body weight measured by bioelectrical impedance scale
  • body mass index [ Time Frame: baseline to week 12 (end of intervention) ]
    body mass index (BMI) will be calculated with the Quetelet index formula
  • body fat mass [ Time Frame: baseline to week 12 (end of intervention) ]
    body fat will be estimated by bioelectrical impedance analysis
  • total cholesterol [ Time Frame: baseline to week 12 (end of intervention) ]
    fasting blood total cholesterol by enzimatic-colorimetric automatized technique
  • Fasting blood C-LDL concentration [ Time Frame: baseline to week 12 (end of intervention) ]
    fasting blood low-density lipoprotein- cholesterol by enzimatic-colorimetric automatized technique
  • Fasting blood VLDL concentration [ Time Frame: baseline to week 12 (end of intervention) ]
    fasting blood very low-density lipoprotein by enzimatic-colorimetric automatized technique
  • Concentration of blood AST and ALT [ Time Frame: baseline / week 12 (end of intervention) ]
    aminotransferases by enzimatic-colorimetric automatized technique
  • Concentration of blood uric acid [ Time Frame: baseline to week 12 (end of intervention) ]
    fasting blood uric acid by enzimatic-colorimetric automatized technique
  • Concentration of blood creatinine [ Time Frame: baseline / week 12 (end of intervention) ]
    creatinine by enzimatic-colorimetric automatized technique
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: baseline to week 12 (continuous surveillance) ]
    Incidence of placebo or ellagic acid, emergent adverse events will be identified by clinical evaluation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Ellagic Ácid on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Official Title  ICMJE Effect of Ellagic Acid Administration on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Brief Summary Metabolic syndrome (MS) is a group of important cardiovascular risk factors: abdominal obesity, dyslipidemia, hyperglycemia, and high blood pressure. Treatment requires the introduction of pharmacological management that includes different medications for each component. Ellagic acid (EA) is a polyphenol that has shown health benefits in multiple experimental studies. AE is consumed by patients without a prescription; considering there aren't studies that demonstrate it's effectiveness on MS, it is important to evaluate the possible effects of AE on this pathology. METHODOLOGY: Current study is a double-blind, placebo-controlled clinical trial. The aim of this study is evaluating the effect of AE on the components of metabolic syndrome, insulin sensitivity, and insulin secretion.
Detailed Description INTRODUCTION: Ellagic acid (EA) is a polyphenol that has shown health benefits in multiple experimental studies; mainly as an antioxidant, but also in hepatic steatosis, endothelial damage, hypertension, diabetes mellitus, visceral fat accumulation, dyslipidemia, insulin resistance, atherosclerosis, etc. There aren't studies that demonstrate the effectiveness of EA on MS; and since it is consumed by patients without any prescription, it is important to evaluate the effect of the administration of EA on the components of metabolic syndrome, insulin sensitivity, and insulin secretion. The current design is a randomized double-blind, placebo-controlled, clinical trial. METHODS: Male and female volunteers between 31 to 60 years of age, with MS diagnosis of MS according to the criteria of the International Diabetes Federation will be included, whether they accept participating and signing the informed consent. Patients with one or more of the following criteria will be excluded: History of liver, kidney, heart, or thyroid disease; systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, fasting blood glucose: ≥126 mg / dL, triglycerides ≥400 mg / dL, LDL cholesterol > 190 mg / dL; pregnancy or lactation; consumption of medications or supplements which interact with EA or that have effects on any of the components of the MS. Patients included, may be withdrawn from the study if they meet any of the following conditions: Withdrawal of the informed consent; compliance with some exclusion criteria during the study; treatment adherence <80%; intolerance to EC or placebo. OBJECTIVES: Main objectives are measuring and comparing before and after the intervention, the effect of EA or placebo on metabolic syndrome components, insulin sensitivity, and insulin secretion. HEADQUARTERS: The study will be carried out in the facilities of the Institute of Experimental and Clinical Therapeutics (INTEC), of the University Center of Health Sciences, in the University of Guadalajara. Guadalajara, Jalisco, Mexico.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double-blind, placebo-controlled clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
randomized double-blind
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Drug: Ellagic Acid / Pomegranate Extract
    Phenolic acid, ellagitannin, found in a wide variety of fruits and nuts; in this particular case, pomegranate extract with ellagic acid 90% 500mg capsules. Homologated to the other intervention. Dosage twice a day orally every 12 hours during 12 weeks
    Other Name: benzoaric acid
  • Drug: Placebo oral capsule
    Calcinated magnesia in 500mg capsules. Homologated to the other intervention. Dosage twice a day orally every 12 hours during 12 weeks
    Other Name: calcinated magnesia
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    16 patients to receive 1 homologated placebo capsule (calcinated magnesia 500 mg) every 12 hours along 12 weeks
    Intervention: Drug: Placebo oral capsule
  • Experimental: Ellagic acid
    16 patients to receive 1 homologated intervention capsule (ellagic acid 500 mg) every 12 hours along 12 weeks
    Intervention: Drug: Ellagic Acid / Pomegranate Extract
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2019) 		32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Metabolic Syndrome diagnosis based on IDF criteria
  • Acceptance and signing of Informed Consent

Exclusion Criteria:

  • Knew kidney, liver, heart or thyroid disease
  • Systolic blood pressure ≥140 mmHg
  • Diastolic blood pressure ≥90 mmHg
  • Fast blood glucose ≥126 mg/dL
  • TG ≥400 mg/dL
  • C-LDL > 190 mg/dL
  • BMI: ≥35 kg/m2
  • Pregnancy or lactation period
  • Knew pomegranate allergy
  • Habitual warfarin, tolbutamide or carbamazepin consumption
  • Effect on any component of metabolic syndrome drugs or suplements regular intake
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 31 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: KARINA G PÉREZ-RUBIO, PhD +523310585200 ext 34212 karina2410@hotmail.com
Contact: MANUEL GONZÁLEZ-ORTIZ, PhD +523310585200 ext 34212 uiec@prodigy.net.mx
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04011618
Other Study ID Numbers  ICMJE Ellagic-SM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karina Griselda Pérez Rubio, University of Guadalajara
Study Sponsor  ICMJE University of Guadalajara
Collaborators  ICMJE National Council of Science and Technology, Mexico
Investigators  ICMJE
Principal Investigator: KARINA G PÉREZ-RUBIO, PhD University of Guadalajara
PRS Account University of Guadalajara
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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