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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients both sexes
Age between 30 and 60 years
Fasting glucose ≥ 100 mg/dL
Triglycerides ≥150 mg/dL
Disqualifiers
Pregnancy or breast-feeding
Glucose ≥126 mg/dL
Total cholesterol ≥240 mg/dL
Triglycerides ≥500mg/dL
Trial design
Parallel
Treatments tested in this trial
Celery Seed
DrugCelery 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.
Placebo
DrugPlacebo 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.
Treatment groups
Trial outcomes
Primary outcomes
Waist Circumference (WC)
Waist Circumference will be evaluated at baseline and week 12 by World Health Organization technique
Systolic Blood Pressure (SBP)
Systolic Blood Pressure (SBP) will be measured at baseline and week 12 with a digital sphygmomanometer three times in each arm to get an average
Diastolic Blood Pressure (DBP)
Diastolic Blood Pressure (DBP) will be measured at baseline and week 12 with a digital sphygmomanometer three times in each arm to get an average
High-Density Lipoprotein (HDL-c)
High density lipoprotein (HDL-c) level will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get c-HDL level
Secondary outcomes
Body weight
Body weight will be measured at baseline and week 12 with a bioimpedance analysis
Body Mass Index (BMI)
Body Mass Index (BMI) will be calculated at baseline and week 12 with the Quetelet index formula
Body Fat Percentage
Body fat percentage will be measured at baseline and week 12 with a bioimpedance analysis
Total Cholesterol (TC)
Total Cholesterol (TC) level will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get total cholesterol level
Sponsors and contacts
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