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

NCT06061926 | Recruiting Phase 2 DMC

• 1 other identifier: Celery Seed-MS
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Celery seed; Metabolic Syndrome; Insulin resistance; Insulin secretion; Insulin sensitivity

Outcome Measures

Primary Outcomes (9)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (12)

• Body weight

  Baseline to week 12 (end of intervention)

• Body Mass Index (BMI)

  Baseline to week 12 (end of intervention)

• Body Fat Percentage

  Baseline to week 12 (end of intervention)

• Total Cholesterol (TC)

  Baseline to week 12 (end of intervention)

• Low Density Lipoprotein (LDL-c)

  Baseline to week 12 (end of intervention)

Study Arms (2)

Celery seed

EXPERIMENTAL

14 patients to receive homologated intervention capsule (celery seed 150 mg) one capsule with 75 mg of celery seed, every 12 hours (before breakfast and before dinner) along 12 weeks.

Drug: Celery Seed

Placebo

PLACEBO COMPARATOR

14 patients to receive homologated placebo capsule (calcinated magnesia) one capsule with calcinated magnesia, every 12 hours (before breakfast and before dinner) along 12 weeks.

Drug: Placebo

Interventions

Celery Seed DRUG

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.

Also known as: Apium graveolens Leen

Celery seed

Placebo DRUG

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.

Also known as: Calcined magnesia

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud

Guadalajara, Jalisco, 44340, Mexico

RECRUITING

Related Publications (1)

• Escobedo-Gutierrez MJ, Cortez-Navarrete M, Martinez-Abundis E, Perez-Rubio KG. Effect of Celery Seed (Apium graveolens L.) Administration on the Components of Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion: A Clinical Trial. Pharmaceuticals (Basel). 2026 Jan 7;19(1):110. doi: 10.3390/ph19010110.

  PMID: 41599709 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Karina G Pérez Rubio, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karina G Pérez Rubio, PhD

CONTACT

+523310585200; karina2410@hotmail.com

Marisol Cortez Navarrete, PhD

CONTACT

+523310585200; cortez_marisol@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double-blind, controlled clinical trial

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: September 29, 2023
• Study Start: May 20, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

ME (1)