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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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

Primary outcome measure(s)

• Waist Circumference (WC) — Baseline to week 12 (end of intervention)
  Waist Circumference will be evaluated at baseline and week 12 by World Health Organization technique
• Systolic Blood Pressure (SBP) — Baseline to week 12 (end of intervention)
  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) — Baseline to week 12 (end of intervention)
  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) — Baseline to week 12 (end of intervention)
  High density lipoprotein (HDL-c) level will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get c-HDL level
• Fasting Blood Triglycerides Concentration (TG) — Baseline to week 12 (end of intervention)
  Fasting Blood Triglycerides Concentration (TG) level will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get triglycerides concentration
• Fasting Serum Glucose (FSG) — Baseline to week 12 (end of intervention)
  The Fasting Serum Glucose (FSG) levels will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get fasting glucose level
• Insulin Sensitivity (Matsuda Index) — Baseline to week 12 (end of intervention)
  Insulin sensitivity will be calculated at baseline and week 12 with Matsuda index to get insulin sensitivity
• Total Insulin Secretion — Baseline to week 12 (end of intervention)
  Total insulin secretion will be calculated at baseline and week 12. It is the result of the ratio between the AUC of insulin in a 2-h OGTT and the AUC of glucose in a 2-h OGTT. It allows estimating the proportion of total insulin secretion in relation to plasma glucose concentration.
• First Phase of Insulin Secretion (Stumvoll Index) — Baseline to week 12 (end of intervention)
  The first phase if insulin secretion will be calculated at baseline and week 12 with Stumvoll index to get first phase of insulin secretion

Trial sites (1)

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