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

NCT04011618 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-06-15

No results posted yet for this study

Summary

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.

Conditions

  • Metabolic Syndrome

Interventions

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

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

Sponsors & Collaborators

  • National Council of Science and Technology, Mexico

    collaborator OTHER

  • University of Guadalajara

    lead OTHER

Principal Investigators

  • KARINA G PÉREZ-RUBIO, PhD · University of Guadalajara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2021-12-30
Completion
2022-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04011618 on ClinicalTrials.gov