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

June 10, 2022 updated by: Karina Griselda Pérez Rubio, University of Guadalajara

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

Metabolic syndrome (MetS) is a group of important cardiovascular risk factors: abdominal obesity, dyslipidemia, hyperglycemia, and high blood pressure. Treatment requires lifestyle changes and pharmacological therapy with different medications for each component. Ellagic acid (EA) is a polyphenol that has shown health benefits in multiple experimental studies. Patients consume EA without prescription; considering there aren't studies that demonstrate its effectiveness on MetS, 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 to evaluate the effect of AE on the components of metabolic syndrome, insulin sensitivity, and insulin secretion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 MetS; since patients consume it 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 30 to 59 years of age, with a diagnosis of MetS according to the International Diabetes Federation criteria 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; diabetes mellitus or arterial hypertension, alcohol, drug abuse or tobacco use, systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, fasting blood glucose ≥126 mg / dL, triglycerides ≥500 mg/dL, LDL cholesterol >190 mg/dL; suspected or confirmed pregnancy, lactation, menopausal period <1 year, hormonal contraceptive or replacement therapy, pharmacological, dietary or herbal therapy in the last 3 months before trial, allergy to any of the interventions. Patients included, may be withdrawn from the study if they meet any of the following conditions: Withdrawal of the informed consent, severe adverse reaction, loss of follow-up, treatment adherence <80%; intolerance to EA or placebo. OBJECTIVES: The main objective is to evaluate 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, at the University of Guadalajara. Guadalajara, Jalisco, Mexico.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior diagnosis of kidney, liver, pancreas, heart or thyroid disease
  • Diabetes mellitus or arterial hypertension
  • Alcoholism, drug abuse or tobacco use
  • Systolic blood pressure ≥140 mmHg
  • Diastolic blood pressure ≥90 mmHg
  • Fasting plasma glucose ≥126 mg/dL
  • TG ≥500 mg/dL
  • C-LDL > 190 mg/dL
  • BMI: ≥35 kg/m2
  • Pregnancy (suspected or confirmed) or lactation
  • Menopausal period <1 year
  • Hormonal contraceptive or replacement therapy
  • Known allergy to any of the interventions
  • Imposibility to shallow capsules
  • Pharmacological, dietary or herbal therapy in the last 3 months before trial
  • Weight variability above ±2.0 kg throughout the last 3 months before intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
16 patients to receive 1 homologated placebo capsule (calcined magnesia 500 mg) every 12 hours along 12 weeks
Drug: Placebo oral capsule
Calcined magnesia in 500mg capsules. Homologated to the other intervention. Dosage twice a day orally every 12 hours during 12 weeks
Other Names:
  • calcined 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
Polyphenol, ellagitannin, it is found in a wide variety of fruits and nuts; in this particular case, pomegranate extract with 90% ellagic acid, 500 mg capsules. Homologated to the other intervention. Dosage twice a day orally every 12 hours during 12 weeks
Other Names:
  • benzoaric acid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
waist circunference
Time Frame: baseline to week 12 (end of intervention)
Main criteria for metabolic syndrome diagnosis
baseline to week 12 (end of intervention)
blood pressure
Time Frame: baseline to week 12 (end of intervention)
systolic blood pressure and diastolyc blood pressure by digital blood pressure monitor
baseline to week 12 (end of intervention)
fasting plasma glucose
Time Frame: baseline to week 12 (end of intervention)
fasting plasma glucose by enzimatic-colorimetric automatized technique
baseline to week 12 (end of intervention)
Fasting plasma triglycerides
Time Frame: baseline to week 12 (end of intervention)
fasting plasma triglycerides by enzimatic-colorimetric automatized technique
baseline to week 12 (end of intervention)
Fasting plasma HDL-c concentration
Time Frame: baseline to week 12 (end of intervention)
fasting plasma high density lypoprotein-cholesterol by enzimatic-colorimetric automatized technique
baseline to week 12 (end of intervention)
Insulin sensitivity
Time Frame: baseline to week 12 (end of intervention)
Estimated with Matsuda index. 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
baseline to week 12 (end of intervention)
Insulin secretion
Time Frame: baseline to week 12 (end of intervention)
Stumvoll index will be used to calculate first-phase and area under curve (AUC) and ratio insulin AUC/glucose AUC for total insulin secretion
baseline to week 12 (end of intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
body weight
Time Frame: baseline to week 12 (end of intervention)
body weight measured by bioelectrical impedance scale
baseline to week 12 (end of intervention)
body mass index
Time Frame: baseline to week 12 (end of intervention)
body mass index (BMI) calculated by Quetelet index
baseline to week 12 (end of intervention)
body fat mass
Time Frame: baseline to week 12 (end of intervention)
body fat will be estimated by bioelectrical impedance analysis. Percentage.
baseline to week 12 (end of intervention)
Fasting plasma uric acid
Time Frame: baseline to week 12 (end of intervention)
fasting plasma uric acid by enzimatic-colorimetric automatized technique
baseline to week 12 (end of intervention)
Fasting plasma insulin
Time Frame: baseline / week 12 (end of intervention)
Fasting plasma insulin concentration by immunoassay
baseline / week 12 (end of intervention)
2 hours after oral-load glucose
Time Frame: baseline / week 12 (end of intervention)
plasma glucose 2 hours after a 75 g oral glucose load
baseline / week 12 (end of intervention)
2 hours after oral-load insulin
Time Frame: baseline / week 12 (end of intervention)
plasma insulin 2 hours after a 75 g oral glucose load
baseline / week 12 (end of intervention)
total cholesterol
Time Frame: baseline to week 12 (end of intervention)
fasting plasma total cholesterol by enzimatic-colorimetric automatized technique
baseline to week 12 (end of intervention)
Fasting plasma LDL-c concentration
Time Frame: baseline to week 12 (end of intervention)
fasting plasma low-density lipoprotein- cholesterol by enzimatic-colorimetric automatized technique
baseline to week 12 (end of intervention)
Fasting plasma VLDL concentration
Time Frame: baseline to week 12 (end of intervention)
fasting plasma very low-density lipoprotein by enzimatic-colorimetric automatized technique
baseline to week 12 (end of intervention)
Concentration of plasma AST
Time Frame: baseline / week 12 (end of intervention)
aminotransferases by enzimatic-colorimetric automatized technique
baseline / week 12 (end of intervention)
Concentration of plasma ALT
Time Frame: baseline / week 12 (end of intervention)
aminotransferases by enzimatic-colorimetric automatized technique
baseline / week 12 (end of intervention)
Concentration of plasma creatinine
Time Frame: baseline / week 12 (end of intervention)
creatinine by enzimatic-colorimetric automatized technique
baseline / week 12 (end of intervention)
Incidence of Adverse events related to placebo or ellagic acid
Time Frame: baseline to week 12 (continuous surveillance)
Incidence of placebo or ellagic acid, emergent adverse events will be identified by clinical evaluation
baseline to week 12 (continuous surveillance)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Guadalajara

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Council of Science and Technology, Mexico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: KARINA G PÉREZ-RUBIO, PhD, University of Guadalajara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ellagic-SM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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