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

NCT ID: NCT04011618

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-17
• Study Completion Date: 2022-12-31

Brief 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.

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

16 patients to receive 1 homologated placebo capsule (calcined magnesia 500 mg) every 12 hours along 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Calcined magnesia in 500mg capsules. Homologated to the other intervention. Dosage twice a day orally every 12 hours during 12 weeks

Ellagic acid

16 patients to receive 1 homologated intervention capsule (ellagic acid 500 mg) every 12 hours along 12 weeks

Group Type: EXPERIMENTAL

Ellagic Acid / Pomegranate Extract

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

benzoaric acid; calcined magnesia

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Council of Science and Technology, Mexico

OTHER

Sponsor Role: collaborator

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Karina Griselda Pérez Rubio

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KARINA G PÉREZ-RUBIO, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guadalajara

Locations

INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

Ellagic-SM

Identifier Type: -

Identifier Source: org_study_id