A Phase 2 interventional study of Thymol in Inflammatory Response and Obesity, sponsored by Centro Universitario de Ciencias de la Salud, Mexico. Status unknown at 1 site in Mexico. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-22.
Sponsored by Centro Universitario de Ciencias de la Salud, Mexico · Phase 2, Interventional, and Treatment
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.
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:
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 30 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Centro Universitario de Ciencias de la Salud, Mexico is the lead sponsor of 27 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects who are known to have a diagnosis, receive treatment, or are observed with:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Thymol
Drug: Thymol
Calcined magnesia
Drug: Thymol
200 mg each 8 hours for 90 days
Netrin-1
Enzyme-Linked ImmunoSorbent Assay
Time frame: Change from baseline netrin-1 at 90 days
IL-6
Enzyme-Linked ImmunoSorbent Assay
Time frame: Change from baseline IL-6 at 90 days
Adiponectin
Enzyme-Linked ImmunoSorbent Assay
Time frame: Change from baseline adiponectin at 90 days
Ultrasensitive C-reactive protein
Enzyme-Linked ImmunoSorbent Assay
Time frame: Change from baseline hs-PCR at 90 days
Glucose
Colorimetry
Time frame: Change from baseline glucosa at 90 days
Insulin Insulina
Colorimetry
Time frame: Change from baseline insulina at 90 days
HDL
Colorimetry
Time frame: Change from baseline HDL at 90 days
LDL
Colorimetry
Time frame: Change from baseline LDL at 90 days
% visceral fat
Bioelectrical impedance analysis
Time frame: Change from baseline % visceral fat at 90 days
Abdominal Circumference
Centimeters
Time frame: Change from baseline abdominal circumference at 90 days
Plan to share: No
Started Apr 2022 (actual). Primary completion is estimated for Dec 2022, 8 months after the start.
Of 132 non-industry phase 2 interventional studies under Obesity, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 57. This study's planned 8 months is below that.
Counting every sponsor, half of 308 studies reached it within 16 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centro Universitario de Ciencias de la Salud, Mexico