Status:
RECRUITING
Effect of Celery Seed on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Lead Sponsor:
University of Guadalajara
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
30-60 years
Phase:
PHASE2
Brief Summary
The Metabolic Syndrome (MS) is a cluster of cardiometabolic risk factors, which include abdominal obesity, hyperglycemia, dyslipidemia, and high blood pressure. MS is a global health problem, it repre...
Detailed Description
A randomized, double-blind controlled clinical trial in 28 patients between 30 to 60 years of age with a diagnosis of MS according to the International Diabetes Federation (IDF) criteria without treat...
Eligibility Criteria
Inclusion
- Patients both sexes
- Age between 30 and 60 years
- Diagnosis of metabolic syndrome (MS) according to the IDF criteria: waist circumference: ≥80 cm (women) ≥90 cm (men), plus two or more of the following:
- Fasting glucose ≥ 100 mg/dL
- Triglycerides ≥150 mg/dL
- HDL-c: Men ≤40 mg/dL, women ≤50 mg/dL
- Blood pressure ≥130/85 mmHg
- Body Mass Index from 25 to 34.9 kg/m²
- Stable weight at least the previous last 3 months (weight variation less than 10%)
- No pharmacological treatment for MS, insulin sensitivity and insulin secretion
- Acceptance and signing of informed consent
Exclusion
- Pregnancy or breast-feeding
- Glucose ≥126 mg/dL
- Total cholesterol ≥240 mg/dL
- Triglycerides ≥500mg/dL
- Systolic blood pressure ≥140 mmHg
- Diastolic blood pressure ≥90 mmHg
- Drugs or supplements consumption with proven properties that modify the behavior of the study variables.
- History of kidney, liver or thyroid disease
Key Trial Info
Start Date :
May 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06061926
Start Date
May 20 2023
End Date
December 1 2025
Last Update
October 23 2024
Active Locations (1)
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1
INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud
Guadalajara, Jalisco, Mexico, 44340