Status:
UNKNOWN
Effect of Ellagic Ácid on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Lead Sponsor:
University of Guadalajara
Collaborating Sponsors:
National Council of Science and Technology, Mexico
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
30-59 years
Phase:
PHASE2
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 pharmac...
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, hypertensi...
Eligibility Criteria
Inclusion
- Metabolic Syndrome diagnosis based on IDF criteria
- Acceptance and signing of Informed Consent
Exclusion
- 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
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04011618
Start Date
September 17 2019
End Date
December 1 2022
Last Update
June 15 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud
Guadalajara, Jalisco, Mexico, 44340