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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061926
• Other study ID #: Celery Seed-MS
• Status: Recruiting
• Phase: Phase 2
• Start date: May 20, 2023
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: University of Guadalajara
• Contact: Karina G Pérez Rubio, PhD
• Phone: +523310585200
• Email: karina2410[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Insulin Resistance
• Metabolic Syndrome
• Syndrome

Intervention

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.
• 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

Country	Name	City	State
Mexico	INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Waist Circumference (WC)	Waist Circumference will be evaluated at baseline and week 12 by World Health Organization technique	Baseline to week 12 (end of intervention)
Primary	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	Baseline to week 12 (end of intervention)
Primary	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	Baseline to week 12 (end of intervention)
Primary	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	Baseline to week 12 (end of intervention)
Primary	Fasting Blood Triglycerides Concentration (TG)	Fasting Blood Triglycerides Concentration (TG) level will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get triglycerides concentration	Baseline to week 12 (end of intervention)
Primary	Fasting Serum Glucose (FSG)	The Fasting Serum Glucose (FSG) levels will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get fasting glucose level	Baseline to week 12 (end of intervention)
Primary	Insulin Sensitivity (Matsuda Index)	Insulin sensitivity will be calculated at baseline and week 12 with Matsuda index to get insulin sensitivity	Baseline to week 12 (end of intervention)
Primary	Total Insulin Secretion	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.	Baseline to week 12 (end of intervention)
Primary	First Phase of Insulin Secretion (Stumvoll Index)	The first phase if insulin secretion will be calculated at baseline and week 12 with Stumvoll index to get first phase of insulin secretion	Baseline to week 12 (end of intervention)
Secondary	Body weight	Body weight will be measured at baseline and week 12 with a bioimpedance analysis	Baseline to week 12 (end of intervention)
Secondary	Body Mass Index (BMI)	Body Mass Index (BMI) will be calculated at baseline and week 12 with the Quetelet index formula	Baseline to week 12 (end of intervention)
Secondary	Body Fat Percentage	Body fat percentage will be measured at baseline and week 12 with a bioimpedance analysis	Baseline to week 12 (end of intervention)
Secondary	Total Cholesterol (TC)	Total Cholesterol (TC) level will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get total cholesterol level	Baseline to week 12 (end of intervention)
Secondary	Low Density Lipoprotein (LDL-c)	Low Density Lipoprotein (LDL-c) level will be calculated at baseline and week 12 with Friedewald formula to get LDL-c level	Baseline to week 12 (end of intervention)
Secondary	Very Low Density Lipoprotein (VLDL)	Very Low Density Lipoprotein (VLDL) level will be calculated at baseline and week 12 with triglycerides concentration/5 formula to get VLDL level	Baseline to week 12 (end of intervention)
Secondary	Concentration of Blood Aspartate Aminostransferase (AST)	Concentration of Blood Aspartate Aminostransferase (AST) level will be evaluated at baseline and week 12 by enzymatic-colorimetric technique to get AST level	Baseline to week 12 (end of intervention)
Secondary	Alanine Aminotransferase (ALT)	Concentration of Blood Alanine Aminostransferase (ALT) level will be evaluated at baseline and week 12 by enzymatic-colorimetric technique to get ALT level	Baseline to week 12 (end of intervention)
Secondary	Creatinine	Concentration of creatinine level will be evaluated at baseline and week 12 by enzymatic-colorimetric technique to get creatinine level	Baseline to week 12 (end of intervention)
Secondary	Uric Acid	Concentration of uric acid level will be evaluated at baseline and week 12 by enzymatic-colorimetric technique to get uric acid level	Baseline to week 12 (end of intervention)
Secondary	Incidence of treatment-Emergent Adverse Events	Incidence of treatment-Emergent Adverse Events of celery seed or placebo will be identified by clinical evaluation from baseline week to week 12 with continuous surveillance	Baseline to week 12 (end of intervention)
Secondary	Tolerability to treatment	Tolerability to treatment of celery seed or placebo will be identified by clinical evaluation from baseline week to week 12 with continuous surveillance	Baseline to week 12 (end of intervention)