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

NCT04011618 Phase 2 UNKNOWN

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.

Details

Lead sponsor	University of Guadalajara
Phase	Phase 2
Status	UNKNOWN
Enrolment	32
Start date	2019-09-17
Completion	2022-12

Conditions

• Metabolic Syndrome

Interventions

• Ellagic Acid / Pomegranate Extract
• Placebo oral capsule

Primary outcomes

• 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

Countries

Mexico