A Phase 2 interventional study of Ellagic Acid / Pomegranate Extract and Placebo oral capsule in Metabolic Syndrome, sponsored by University of Guadalajara. Status unknown at 1 site in Mexico. Open to participants aged 30 Years to 59 Years. Per ClinicalTrials.gov, last updated 2022-06-15.
Sponsored by University of Guadalajara · Phase 2, Interventional, and Treatment
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.
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 32 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
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Exclusion Criteria:
16 patients to receive 1 homologated placebo capsule (calcined magnesia 500 mg) every 12 hours along 12 weeks
Drug: Placebo oral capsule
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
Also known as: benzoaric acid
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
waist circunference
Main criteria for metabolic syndrome diagnosis
Time frame: baseline to week 12 (end of intervention)
blood pressure
systolic blood pressure and diastolyc blood pressure by digital blood pressure monitor
Time frame: baseline to week 12 (end of intervention)
fasting plasma glucose
fasting plasma glucose by enzimatic-colorimetric automatized technique
Time frame: baseline to week 12 (end of intervention)
Fasting plasma triglycerides
fasting plasma triglycerides by enzimatic-colorimetric automatized technique
Time frame: baseline to week 12 (end of intervention)
Fasting plasma HDL-c concentration
fasting plasma high density lypoprotein-cholesterol by enzimatic-colorimetric automatized technique
Time frame: 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
Time frame: 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
Time frame: baseline to week 12 (end of intervention)
body weight
body weight measured by bioelectrical impedance scale
Time frame: baseline to week 12 (end of intervention)
body mass index
body mass index (BMI) calculated by Quetelet index
Time frame: baseline to week 12 (end of intervention)
body fat mass
body fat will be estimated by bioelectrical impedance analysis. Percentage.
Time frame: baseline to week 12 (end of intervention)
Fasting plasma uric acid
fasting plasma uric acid by enzimatic-colorimetric automatized technique
Time frame: baseline to week 12 (end of intervention)
Fasting plasma insulin
Fasting plasma insulin concentration by immunoassay
Time frame: baseline / week 12 (end of intervention)
2 hours after oral-load glucose
plasma glucose 2 hours after a 75 g oral glucose load
Time frame: baseline / week 12 (end of intervention)
2 hours after oral-load insulin
plasma insulin 2 hours after a 75 g oral glucose load
Time frame: baseline / week 12 (end of intervention)
total cholesterol
fasting plasma total cholesterol by enzimatic-colorimetric automatized technique
Time frame: baseline to week 12 (end of intervention)
Fasting plasma LDL-c concentration
fasting plasma low-density lipoprotein- cholesterol by enzimatic-colorimetric automatized technique
Time frame: baseline to week 12 (end of intervention)
Fasting plasma VLDL concentration
fasting plasma very low-density lipoprotein by enzimatic-colorimetric automatized technique
Time frame: baseline to week 12 (end of intervention)
Concentration of plasma AST
aminotransferases by enzimatic-colorimetric automatized technique
Time frame: baseline / week 12 (end of intervention)
Concentration of plasma ALT
aminotransferases by enzimatic-colorimetric automatized technique
Time frame: baseline / week 12 (end of intervention)
Concentration of plasma creatinine
creatinine by enzimatic-colorimetric automatized technique
Time frame: baseline / week 12 (end of intervention)
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
Time frame: baseline to week 12 (continuous surveillance)
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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University of Guadalajara