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

NCT04011618 | Unknown Phase 2 DMC

• 1 other identifier: Ellagic-SM
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

ellagic acid; metabolic syndrome; insulin resistance; insulin secretion; insulin sensitivity

Outcome Measures

Primary Outcomes (7)

• waist circunference

  Main criteria for metabolic syndrome diagnosis

  baseline to week 12 (end of intervention)

• blood pressure

  systolic blood pressure and diastolyc blood pressure by digital blood pressure monitor

  baseline to week 12 (end of intervention)

• fasting plasma glucose

  fasting plasma glucose by enzimatic-colorimetric automatized technique

  baseline to week 12 (end of intervention)

• Fasting plasma triglycerides

  fasting plasma triglycerides by enzimatic-colorimetric automatized technique

  baseline to week 12 (end of intervention)

• Fasting plasma HDL-c concentration

  fasting plasma high density lypoprotein-cholesterol by enzimatic-colorimetric automatized technique

  baseline to week 12 (end of intervention)

• Insulin sensitivity

  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

  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 Outcomes (14)

• body weight

  baseline to week 12 (end of intervention)

• body mass index

  baseline to week 12 (end of intervention)

• body fat mass

  baseline to week 12 (end of intervention)

• Fasting plasma uric acid

  baseline to week 12 (end of intervention)

• Fasting plasma insulin

  baseline / week 12 (end of intervention)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule

Ellagic acid

EXPERIMENTAL

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

Drug: Ellagic Acid / Pomegranate Extract

Interventions

Ellagic Acid / Pomegranate Extract 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

Also known as: benzoaric acid

Ellagic acid

Placebo oral capsule DRUG

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

Also known as: calcined magnesia

Placebo

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead
• National Council of Science and Technology, Mexico: collaborator

Study Sites (1)

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

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Interventions

Ellagic Acid

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• KARINA G PÉREZ-RUBIO, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: randomized double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 8, 2019
• Study Start: September 17, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 1, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

ME (1)