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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Mexico
INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud
RECRUITING
Guadalajara
Contact Information
Primary
Karina G Pérez Rubio, PhD
karina2410@hotmail.com
+523310585200
Backup
Marisol Cortez Navarrete, PhD
cortez_marisol@hotmail.com
+523310585200
Time Frame
Start Date: 2023-05-20
Estimated Completion Date: 2025-12
Participants
Target number of participants: 28
Treatments
Experimental: Celery seed
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.
Placebo_comparator: Placebo
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.
Related Therapeutic Areas
Sponsors
Leads: University of Guadalajara

This content was sourced from clinicaltrials.gov