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Recruiting Phase 2 NCT06061926

Effect of Celery Seed on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Trial Parameters

Condition Metabolic Syndrome
Sponsor University of Guadalajara
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 28
Sex ALL
Min Age 30 Years
Max Age 60 Years
Start Date 2023-05-20
Completion 2025-06
Interventions
Celery SeedPlacebo

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 represents a risk factor for the progression of cardiovascular disease, which constitute the main cause of mortality in the world and in Mexico. The current treatment involves lifestyle changes and pharmacological treatment for each of the components of MS, however, there is no single approved treatment to control all components. Celery seed (Apium graveolens L.) from the Apiaceae family contains the flavonoids apigenin and luteolin; essential oils such as d-limonene, selinene and phthalides such as 3-n-butylphthalide. Thanks to its bioactive components, celery seed has proven to be effective in treating individual MS disorders; however, most studies are in animal models and there are no clinical studies that evaluate its effectiveness on all components of the system. MS, insulin sensitivity and insulin secretion so it could appear as a new, safe and effective complementary therapy for the treatment of MS. The aim of this study is to evaluate the effect of celery seed on the components of metabolic syndrome, insulin sensitivity, and insulin secretion.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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

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