RECRUITINGPhase 2INTERVENTIONAL

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

Effect of Celery Seed (Apium Graveolens L.) Administration on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Celery Seed

Celery seed capsules (Apium graveolens L.) 150 mg twice times at day, one capsule with 75 mg before breakfast and one capsule with 75 mg before dinner during 12 weeks. Homologated to the other intervention. Oral administration.

DRUG

Placebo

Placebo capsules (calcined magnesia) twice times at day, one capsule before breakfast and one capsule before dinner during 12 weeks. Homologated to the other intervention. Oral administration.

Locations (1)

INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud

Guadalajara, Jalisco, Mexico