NCT05427721

Thymol on Netrin-1 on Obese Patients

Thymol Administration Effects on Netrin-1 Serum Concentration on Obese Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Centro Universitario de Ciencias de la Salud, Mexico · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The prevalence of obesity in Mexico is 35.4%, and it is considered a risk factor for the development of diabetes, systemic arterial hypertension and dyslipidemia. Obesity due to the increased distribution and growth of adipose tissue creates a pro-inflammatory state induced by molecules secreted by the adipocytes themselves. Netrin-1 is a cell migration protein, which directs the recruitment, migration and entrapment of macrophages in different tissues, within adipose tissue the entrapment of macrophages induces the release of pro-inflammatory cytokines, which increase the secretion of pro-inflammatory adipokines. It has been found in high concentration in patients with obesity, insulin resistance and type 2 diabetes. Thymol is a phytopharmaceutical derived from oregano oil that has shown powerful anti-inflammatory and antioxidant effects through the stimulation of PPAR-gamma, adiponectin and inhibition of the NF-κB pathway mediated by the JNK pathway, pathways in which netrin-1 is involved in macrophage entrapment and recruitment.

Detailed description

Objective: To evaluate the effect of thymol administration on the serum concentration of netrin-1 in obese subjects. Material and methods: this is a randomized, double-blind, placebo-controlled clinical trial design. Inclusion criteria: 1. \- Subjects between 18 and 35 years old. 2. \- Subjects with BMI ≥ 30.0 and ≤35.0. 3. \- Subjects with systolic blood pressure less than 135 mmHg. 4. \- Subjects with diastolic blood pressure less than 85 mmHg. 5. \- Voluntary acceptance and signing of the informed consent. These patients will be randomly assigned to two groups, one will have the intervention with thymol 200 mg every 8 hours for 90 days while the other will have placebo with Mg 200 mg every 8 hours for 90 days. Statistical analysis: quantitative variables: means and standard deviation. Qualitative variables: frequencies and percentages. In the comparison according to the serum level of netrin-1 between the two groups after the intervention: t student for quantitative variables, Chi square for qualitative variables. Statistical significance p equal to or less than 0.05.

Conditions

• Inflammatory Response
• Obesity

Interventions

Type	Name	Description
DRUG	Thymol	200 mg each 8 hours for 90 days

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-12-15
• Completion: 2022-12-30
• First posted: 2022-06-22
• Last updated: 2022-06-22

Locations

1 site across 1 country: Mexico

Regulatory

• FDA-regulated drug study