Clinical trial NCT06061926: Effect of Celery Seed on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Official title: Effect of Celery Seed (Apium Graveolens L.) Administration on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metabolic Syndrome
Keywords: Celery seed
Metabolic Syndrome
Insulin resistance
Insulin secretion
Insulin sensitivity
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, controlled clinical trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Waist Circumference (WC)
timeFrame: Baseline to week 12 (end of intervention)
measure: Systolic Blood Pressure (SBP)
timeFrame: Baseline to week 12 (end of intervention)
measure: Diastolic Blood Pressure (DBP)
timeFrame: Baseline to week 12 (end of intervention)
measure: High-Density Lipoprotein (HDL-c)
timeFrame: Baseline to week 12 (end of intervention)
measure: Fasting Blood Triglycerides Concentration (TG)
timeFrame: Baseline to week 12 (end of intervention)
measure: Fasting Serum Glucose (FSG)
timeFrame: Baseline to week 12 (end of intervention)
measure: Insulin Sensitivity (Matsuda Index)
timeFrame: Baseline to week 12 (end of intervention)
measure: Total Insulin Secretion
timeFrame: Baseline to week 12 (end of intervention)
measure: First Phase of Insulin Secretion (Stumvoll Index)
timeFrame: Baseline to week 12 (end of intervention)
Secondary outcomes:
measure: Body weight
timeFrame: Baseline to week 12 (end of intervention)
measure: Body Mass Index (BMI)
timeFrame: Baseline to week 12 (end of intervention)
measure: Body Fat Percentage
timeFrame: Baseline to week 12 (end of intervention)
measure: Total Cholesterol (TC)
timeFrame: Baseline to week 12 (end of intervention)
measure: Low Density Lipoprotein (LDL-c)
timeFrame: Baseline to week 12 (end of intervention)
measure: Very Low Density Lipoprotein (VLDL)
timeFrame: Baseline to week 12 (end of intervention)
measure: Concentration of Blood Aspartate Aminostransferase (AST)
timeFrame: Baseline to week 12 (end of intervention)
measure: Alanine Aminotransferase (ALT)
timeFrame: Baseline to week 12 (end of intervention)
measure: Creatinine
timeFrame: Baseline to week 12 (end of intervention)
measure: Uric Acid
timeFrame: Baseline to week 12 (end of intervention)
measure: Incidence of treatment-Emergent Adverse Events
timeFrame: Baseline to week 12 (end of intervention)
measure: Tolerability to treatment
timeFrame: Baseline to week 12 (end of intervention)
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Karina G Pérez Rubio, PhD
role: PRINCIPAL_INVESTIGATOR
References: