Effects of celery seed on metabolic syndrome and insulin sensitivity
Effect of Celery Seed (Apium Graveolens L.) Administration on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
This study is testing if celery seed extract can help people with metabolic syndrome improve their insulin sensitivity and overall health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 30 Years to 60 Years |
| Sex | All |
| Sponsor | University of Guadalajara Academic / other |
| Locations | 1 site (Guadalajara, Jalisco) |
| Trial ID | NCT06061926 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of celery seed on various components of metabolic syndrome, including insulin sensitivity and secretion. It involves a randomized, double-blind, controlled design with 28 participants aged 30 to 60 who meet the International Diabetes Federation criteria for metabolic syndrome. Participants will be divided into two groups, one receiving celery seed extract and the other a placebo, over a 12-week period. Key health metrics such as waist circumference, blood pressure, fasting glucose, and lipid levels will be assessed before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 60 with a diagnosis of metabolic syndrome who are not currently on pharmacological treatment.
Not a fit: Patients with severe metabolic abnormalities or those on medications affecting study variables may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural treatment option for managing metabolic syndrome and its associated risks.
How similar studies have performed: While celery seed has shown promise in animal studies, this approach is novel as there are no prior clinical studies evaluating its effectiveness on all components of metabolic syndrome.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guadalajara, Jalisco
- INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud — Guadalajara, Jalisco, Mexico (Recruiting)
Study contacts
- Principal investigator: Karina G Pérez Rubio, PhD — University of Guadalajara
- Study coordinator: Karina G Pérez Rubio, PhD
- Email: karina2410@hotmail.com
- Phone: +523310585200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.