NCT06061926 Effect of Celery Seed on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
| NCT ID | NCT06061926 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Guadalajara |
| Condition | Metabolic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2023-05-20 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 28 participants in total. It began in 2023-05-20 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Karina G Pérez Rubio, PhD
PRINCIPAL INVESTIGATOR
University of Guadalajara
Frequently Asked Questions
Who can join the NCT06061926 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 60 Years, studying Metabolic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06061926 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06061926 currently recruiting?
Yes, NCT06061926 is actively recruiting participants. Contact the research team at karina2410@hotmail.com for enrollment information.
Where is the NCT06061926 trial being conducted?
This trial is being conducted at Guadalajara, Mexico.
Who is sponsoring the NCT06061926 clinical trial?
NCT06061926 is sponsored by University of Guadalajara. The principal investigator is Karina G Pérez Rubio, PhD at University of Guadalajara. The trial plans to enroll 28 participants.