Metabolic Syndrome
Conditions
Keywords
ellagic acid, metabolic syndrome, insulin resistance, insulin secretion, insulin sensitivity
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 Patients included, may be withdrawn from the study if they meet any of the following conditions: Withdrawal of the informed consent, severe adverse reaction, loss of follow-up, treatment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.
Interventions
DRUGEllagic 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
DRUGPlacebo oral capsule
Calcined magnesia in 500mg capsules. Homologated to the other intervention. Dosage twice a day orally every 12 hours during 12 weeks
Sponsors
National Council of Science and Technology, Mexico
University of Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
randomized double-blind
Intervention model description
Double-blind, placebo-controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
30 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| waist circunference | baseline to week 12 (end of intervention) | Main criteria for metabolic syndrome diagnosis |
| blood pressure | baseline to week 12 (end of intervention) | systolic blood pressure and diastolyc blood pressure by digital blood pressure monitor |
| fasting plasma glucose | baseline to week 12 (end of intervention) | fasting plasma glucose by enzimatic-colorimetric automatized technique |
| Fasting plasma triglycerides | baseline to week 12 (end of intervention) | fasting plasma triglycerides by enzimatic-colorimetric automatized technique |
| Fasting plasma HDL-c concentration | baseline to week 12 (end of intervention) | fasting plasma high density lypoprotein-cholesterol by enzimatic-colorimetric automatized technique |
| Insulin sensitivity | baseline to week 12 (end of intervention) | 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 |
| Insulin secretion | baseline to week 12 (end of intervention) | Stumvoll index will be used to calculate first-phase and area under curve (AUC) and ratio insulin AUC/glucose AUC for total insulin secretion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total cholesterol | baseline to week 12 (end of intervention) | fasting plasma total cholesterol by enzimatic-colorimetric automatized technique |
| Fasting plasma LDL-c concentration | baseline to week 12 (end of intervention) | fasting plasma low-density lipoprotein- cholesterol by enzimatic-colorimetric automatized technique |
| Fasting plasma VLDL concentration | baseline to week 12 (end of intervention) | fasting plasma very low-density lipoprotein by enzimatic-colorimetric automatized technique |
| body weight | baseline to week 12 (end of intervention) | body weight measured by bioelectrical impedance scale |
| Concentration of plasma ALT | baseline / week 12 (end of intervention) | aminotransferases by enzimatic-colorimetric automatized technique |
| Concentration of plasma creatinine | baseline / week 12 (end of intervention) | creatinine by enzimatic-colorimetric automatized technique |
| Incidence of Adverse events related to placebo or ellagic acid | baseline to week 12 (continuous surveillance) | Incidence of placebo or ellagic acid, emergent adverse events will be identified by clinical evaluation |
| Concentration of plasma AST | baseline / week 12 (end of intervention) | aminotransferases by enzimatic-colorimetric automatized technique |
| body mass index | baseline to week 12 (end of intervention) | body mass index (BMI) calculated by Quetelet index |
| body fat mass | baseline to week 12 (end of intervention) | body fat will be estimated by bioelectrical impedance analysis. Percentage. |
| Fasting plasma uric acid | baseline to week 12 (end of intervention) | fasting plasma uric acid by enzimatic-colorimetric automatized technique |
| Fasting plasma insulin | baseline / week 12 (end of intervention) | Fasting plasma insulin concentration by immunoassay |
| 2 hours after oral-load glucose | baseline / week 12 (end of intervention) | plasma glucose 2 hours after a 75 g oral glucose load |
| 2 hours after oral-load insulin | baseline / week 12 (end of intervention) | plasma insulin 2 hours after a 75 g oral glucose load |
Countries
Mexico
Outcome results
None listed