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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04011618
• Other study ID #: Ellagic-SM
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 17, 2019
• Est. completion date: December 2022

Study information

• Verified date: June 2022
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: December 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Insulin Resistance
• Metabolic Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Mexico	INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud	Guadalajara	Jalisco

Sponsors (2)

Lead Sponsor	Collaborator
University of Guadalajara	National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	waist circunference	Main criteria for metabolic syndrome diagnosis	baseline to week 12 (end of intervention)
Primary	blood pressure	systolic blood pressure and diastolyc blood pressure by digital blood pressure monitor	baseline to week 12 (end of intervention)
Primary	fasting plasma glucose	fasting plasma glucose by enzimatic-colorimetric automatized technique	baseline to week 12 (end of intervention)
Primary	Fasting plasma triglycerides	fasting plasma triglycerides by enzimatic-colorimetric automatized technique	baseline to week 12 (end of intervention)
Primary	Fasting plasma HDL-c concentration	fasting plasma high density lypoprotein-cholesterol by enzimatic-colorimetric automatized technique	baseline to week 12 (end of intervention)
Primary	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)
Primary	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	body weight	body weight measured by bioelectrical impedance scale	baseline to week 12 (end of intervention)
Secondary	body mass index	body mass index (BMI) calculated by Quetelet index	baseline to week 12 (end of intervention)
Secondary	body fat mass	body fat will be estimated by bioelectrical impedance analysis. Percentage.	baseline to week 12 (end of intervention)
Secondary	Fasting plasma uric acid	fasting plasma uric acid by enzimatic-colorimetric automatized technique	baseline to week 12 (end of intervention)
Secondary	Fasting plasma insulin	Fasting plasma insulin concentration by immunoassay	baseline / week 12 (end of intervention)
Secondary	2 hours after oral-load glucose	plasma glucose 2 hours after a 75 g oral glucose load	baseline / week 12 (end of intervention)
Secondary	2 hours after oral-load insulin	plasma insulin 2 hours after a 75 g oral glucose load	baseline / week 12 (end of intervention)
Secondary	total cholesterol	fasting plasma total cholesterol by enzimatic-colorimetric automatized technique	baseline to week 12 (end of intervention)
Secondary	Fasting plasma LDL-c concentration	fasting plasma low-density lipoprotein- cholesterol by enzimatic-colorimetric automatized technique	baseline to week 12 (end of intervention)
Secondary	Fasting plasma VLDL concentration	fasting plasma very low-density lipoprotein by enzimatic-colorimetric automatized technique	baseline to week 12 (end of intervention)
Secondary	Concentration of plasma AST	aminotransferases by enzimatic-colorimetric automatized technique	baseline / week 12 (end of intervention)
Secondary	Concentration of plasma ALT	aminotransferases by enzimatic-colorimetric automatized technique	baseline / week 12 (end of intervention)
Secondary	Concentration of plasma creatinine	creatinine by enzimatic-colorimetric automatized technique	baseline / week 12 (end of intervention)
Secondary	Incidence of Adverse events related to placebo or ellagic acid	Incidence of placebo or ellagic acid, emergent adverse events will be identified by clinical evaluation	baseline to week 12 (continuous surveillance)