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

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 treatment and whether they voluntary accept participating and signing the informed consent.

Patients with one or more of the following criteria will be excluded: History of kidney, thyroid or liver disease; systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, fasting glucose ≥ 126 mg/dL, triglycerides ≥ 500 mg/dL, total cholesterol ≥240 mg/dL; pregnancy or lactation; consumption of medications or supplements with effects on the study variables.

Patients included, may be withdrawn from the study if they meet any of the following conditions: Withdrawal of the informed consent, treatment adherence <80%, severe adverse reaction, intolerance or hypersensitivity to celery seed or placebo.

They will be assigned randomly two groups of 14 patients; one of the groups will receive 75 mg of celery seed twice at day (before breakfast and dinner) for 12 weeks.

The other group will receive homologated placebo (calcined magnesia) twice at day (before breakfast and dinner) for 12 weeks.

Waist circumference, blood pressure, fasting blood glucose, serum triglycerides and serum HDL cholesterol will be evaluated before and after intervention in both groups. Insulin sensitivity (Matsuda index), total insulin secretion (it is the result of the ratio between the area under the curve (AUC) of insulin in a 2-h OGTT and the AUC of glucose in a 2-h OGTT) and First phase of insulin secretion (Stumvoll index), will be calculated from the concentration of glucose and insulin obtained from an Oral Glucose Tolerance Test.

This protocol It´s already approved by the local ethics committee and written informed consent it´s going to be obtained from all volunteers.

Statistical analysis will be presented through measures of central tendency and dispersion, mean and deviation standard for quantitative variables; frequencies and percentage for qualitative variable. The analysis between groups (independent samples) will be analyzed using the Mann-Whitney U test for quantitative variables and the X2 test or Fisher's exact test for qualitative variables. The intragroup analysis (two related samples) will be performed using the Wilcoxon range test for quantitative variables. Statistical significance will be considered with a p<0.05.

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