Clinical trial NCT04011618: Effect of Ellagic Ácid on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Official title: Effect of Ellagic Acid Administration on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metabolic Syndrome
Keywords: ellagic acid
metabolic syndrome
insulin resistance
insulin secretion
insulin sensitivity
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
Collaborators: name: National Council of Science and Technology, Mexico
First posted: 2019-07-08
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, placebo-controlled clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: waist circunference
timeFrame: baseline to week 12 (end of intervention)
measure: blood pressure
timeFrame: baseline to week 12 (end of intervention)
measure: fasting plasma glucose
timeFrame: baseline to week 12 (end of intervention)
measure: Fasting plasma triglycerides
timeFrame: baseline to week 12 (end of intervention)
measure: Fasting plasma HDL-c concentration
timeFrame: baseline to week 12 (end of intervention)
measure: Insulin sensitivity
timeFrame: baseline to week 12 (end of intervention)
measure: Insulin secretion
timeFrame: baseline to week 12 (end of intervention)
Secondary outcomes:
measure: body weight
timeFrame: baseline to week 12 (end of intervention)
measure: body mass index
timeFrame: baseline to week 12 (end of intervention)
measure: body fat mass
timeFrame: baseline to week 12 (end of intervention)
measure: Fasting plasma uric acid
timeFrame: baseline to week 12 (end of intervention)
measure: Fasting plasma insulin
timeFrame: baseline / week 12 (end of intervention)
measure: 2 hours after oral-load glucose
timeFrame: baseline / week 12 (end of intervention)
measure: 2 hours after oral-load insulin
timeFrame: baseline / week 12 (end of intervention)
measure: total cholesterol
timeFrame: baseline to week 12 (end of intervention)
measure: Fasting plasma LDL-c concentration
timeFrame: baseline to week 12 (end of intervention)
measure: Fasting plasma VLDL concentration
timeFrame: baseline to week 12 (end of intervention)
measure: Concentration of plasma AST
timeFrame: baseline / week 12 (end of intervention)
measure: Concentration of plasma ALT
timeFrame: baseline / week 12 (end of intervention)
measure: Concentration of plasma creatinine
timeFrame: baseline / week 12 (end of intervention)
measure: Incidence of Adverse events related to placebo or ellagic acid
timeFrame: baseline to week 12 (continuous surveillance)
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: KARINA G PÉREZ-RUBIO, PhD
role: PRINCIPAL_INVESTIGATOR
References: