Inflammatory ResponsePhase 2NCT05427721
Thymol on Netrin-1 on Obese Patients
A Phase 2 study testing Thymol in people with Inflammatory Response and Obesity, run by Centro Universitario de Ciencias de la Salud, Mexico at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Response, Obesity
- What is being tested?
- Thymol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 1 Apr 2022to 30 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects between 18 and 35 years old.
- BMI ≥ 30.0 and ≤35.0
- Systolic blood pressure less than 135 mmHg.
- Diastolic blood pressure less than 85 mmHg.
Who cannot join
- Subjects who are known to have a diagnosis, receive treatment, or are observed with:
- Rheumatological and / or thyroid disease.
- Chronic kidney disease and / or CKD-EPI glomerular filtration rate less than 60 ml / min / 1.72m2.
- Innate alterations of metabolism.
- Elevation of transaminases 2 times higher than normal.
- Total cholesterol greater than 250 mg / dl.
Show all 13Show fewer
- Triglycerides greater than 300 mg / dl.
- Subjects presenting with acute illness, hospitalization, or drug treatment presented in the last 12 weeks prior to the study selection visit.
- Subjects with symptoms consistent with the definition of a probable case of COVID-19, as well as any subject with a diagnosis of COVID-19.
- Subjects who have had blood transfusions in the last 3 months.
- Regular smokers.
- Pregnant or lactating women.
- Women with a desire for pregnancy or who do not have a double barrier or progestin-only contraceptive method.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
INTEC, CUCS, Universidad de Guadalajara
Guadalajara, Jalisco, 4430
Maria G Ramos-Zavala, PhD, 3339533367, ramos.zavala.mg@gmail.com
Jesus J Garcia-Galindo, MD, 3325828575, dr.jonathangarcia1418@gmail.com
About this study
Official title: Thymol Administration Effects on Netrin-1 Serum Concentration on Obese Patients
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.
Read the 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:
- - Subjects between 18 and 35 years old.
- - Subjects with BMI ≥ 30.0 and ≤35.0.
- - Subjects with systolic blood pressure less than 135 mmHg.
- - Subjects with diastolic blood pressure less than 85 mmHg.
- - 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
- Being tested
- Thymol
- Keywords
- Netrin-1, Thymol
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymolDrug
200 mg each 8 hours for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Thymol Receives: Drug: Thymol |
| Group B | Placebo comparator | Calcined magnesia Receives: Drug: Thymol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Netrin-1
Enzyme-Linked ImmunoSorbent Assay
Measured: Change from baseline netrin-1 at 90 days
Secondary outcomes (3)
IL-6
Enzyme-Linked ImmunoSorbent Assay
Measured: Change from baseline IL-6 at 90 days
Adiponectin
Enzyme-Linked ImmunoSorbent Assay
Measured: Change from baseline adiponectin at 90 days
Ultrasensitive C-reactive protein
Enzyme-Linked ImmunoSorbent Assay
Measured: Change from baseline hs-PCR at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Apr 2022
- Primary completion15 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Guadalupe Ramos Zavala, Centro Universitario de Ciencias de la Salud, Mexico
- Investigators
- Maria G Ramos-Zavala, PhD, Study chair, Centro Universitario de Ciencias de la Salud, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427721
- Sponsor's protocol ID
- CI-01621
- Other IDs
- 20-131
- Status last verified
- Jun 2022
- First submitted
- 11 Jun 2021
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hammarstedt A, Gogg S, Hedjazifar S, Nerstedt A, Smith U. Impaired Adipogenesis and Dysfunctional Adipose Tissue in Human Hypertrophic Obesity. Physiol Rev. 2018 Oct 1;98(4):1911-1941. doi: 10.1152/physrev.00034.2017.
PubMed 30067159Stern JH, Rutkowski JM, Scherer PE. Adiponectin, Leptin, and Fatty Acids in the Maintenance of Metabolic Homeostasis through Adipose Tissue Crosstalk. Cell Metab. 2016 May 10;23(5):770-84. doi: 10.1016/j.cmet.2016.04.011.
PubMed 27166942Trayhurn P. Hypoxia and adipose tissue function and dysfunction in obesity. Physiol Rev. 2013 Jan;93(1):1-21. doi: 10.1152/physrev.00017.2012.
PubMed 23303904Han MS, Jung DY, Morel C, Lakhani SA, Kim JK, Flavell RA, Davis RJ. JNK expression by macrophages promotes obesity-induced insulin resistance and inflammation. Science. 2013 Jan 11;339(6116):218-22. doi: 10.1126/science.1227568. Epub 2012 Dec 6.
PubMed 23223452Lee KY, Gesta S, Boucher J, Wang XL, Kahn CR. The differential role of Hif1beta/Arnt and the hypoxic response in adipose function, fibrosis, and inflammation. Cell Metab. 2011 Oct 5;14(4):491-503. doi: 10.1016/j.cmet.2011.08.006.
PubMed 21982709Bouhlel MA, Derudas B, Rigamonti E, Dievart R, Brozek J, Haulon S, Zawadzki C, Jude B, Torpier G, Marx N, Staels B, Chinetti-Gbaguidi G. PPARgamma activation primes human monocytes into alternative M2 macrophages with anti-inflammatory properties. Cell Metab. 2007 Aug;6(2):137-43. doi: 10.1016/j.cmet.2007.06.010.
PubMed 17681149Yim J, Kim G, Lee BW, Kang ES, Cha BS, Kim JH, Cho JW, Lee SG, Lee YH. Relationship Between Circulating Netrin-1 Concentration, Impaired Fasting Glucose, and Newly Diagnosed Type 2 Diabetes. Front Endocrinol (Lausanne). 2018 Nov 23;9:691. doi: 10.3389/fendo.2018.00691. eCollection 2018.
PubMed 30532735Nagoor Meeran MF, Javed H, Al Taee H, Azimullah S, Ojha SK. Pharmacological Properties and Molecular Mechanisms of Thymol: Prospects for Its Therapeutic Potential and Pharmaceutical Development. Front Pharmacol. 2017 Jun 26;8:380. doi: 10.3389/fphar.2017.00380. eCollection 2017.
PubMed 28694777Nieddu M, Rassu G, Boatto G, Bosi P, Trevisi P, Giunchedi P, Carta A, Gavini E. Improvement of thymol properties by complexation with cyclodextrins: in vitro and in vivo studies. Carbohydr Polym. 2014 Feb 15;102:393-9. doi: 10.1016/j.carbpol.2013.10.084. Epub 2013 Nov 20.
PubMed 24507296Yu YM, Chao TY, Chang WC, Chang MJ, Lee MF. Thymol reduces oxidative stress, aortic intimal thickening, and inflammation-related gene expression in hyperlipidemic rabbits. J Food Drug Anal. 2016 Jul;24(3):556-563. doi: 10.1016/j.jfda.2016.02.004. Epub 2016 Apr 12.
PubMed 28911561Kohlert C, Schindler G, Marz RW, Abel G, Brinkhaus B, Derendorf H, Grafe EU, Veit M. Systemic availability and pharmacokinetics of thymol in humans. J Clin Pharmacol. 2002 Jul;42(7):731-7. doi: 10.1177/009127002401102678.
PubMed 12092740Salehi B, Mishra AP, Shukla I, Sharifi-Rad M, Contreras MDM, Segura-Carretero A, Fathi H, Nasrabadi NN, Kobarfard F, Sharifi-Rad J. Thymol, thyme, and other plant sources: Health and potential uses. Phytother Res. 2018 Sep;32(9):1688-1706. doi: 10.1002/ptr.6109. Epub 2018 May 22.
PubMed 29785774Paul S, Baranya Shrikrishna S, Suman E, Shenoy R, Rao A. Effect of fluoride varnish and chlorhexidine-thymol varnish on mutans streptococci levels in human dental plaque: a double-blinded randomized controlled trial. Int J Paediatr Dent. 2014 Nov;24(6):399-408. doi: 10.1111/ipd.12085. Epub 2013 Dec 25.
PubMed 24372823Marzouk T, Barakat R, Ragab A, Badria F, Badawy A. Lavender-thymol as a new topical aromatherapy preparation for episiotomy: A randomised clinical trial. J Obstet Gynaecol. 2015;35(5):472-5. doi: 10.3109/01443615.2014.970522.
PubMed 25384116Saravanan S, Pari L. Role of thymol on hyperglycemia and hyperlipidemia in high fat diet-induced type 2 diabetic C57BL/6J mice. Eur J Pharmacol. 2015 Aug 15;761:279-87. doi: 10.1016/j.ejphar.2015.05.034. Epub 2015 May 22.
PubMed 26007642
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thymol Administration Effects on Netrin-1 Serum Concentration on Obese Patients
- ClinicalTrials.gov ID
- NCT05427721
- Acronym / sponsor ID
- CI-01621
- Conditions
- Inflammatory Response, Obesity
- Keywords
- Netrin-1, Thymol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, MexicoUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- - Subjects between 18 and 35 years old.
- - Subjects with BMI ≥ 30.0 and ≤35.0.
- - Subjects with systolic blood pressure less than 135 mmHg.
- - Subjects with diastolic blood pressure less than 85 mmHg.
- - 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: ThymolThymol |
| Group B | Placebo comparator | Drug: ThymolCalcined magnesia |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects between 18 and 35 years old.
- BMI ≥ 30.0 and ≤35.0
- Systolic blood pressure less than 135 mmHg.
- Diastolic blood pressure less than 85 mmHg.
Key exclusion criteria (13 listed)
- Subjects who are known to have a diagnosis, receive treatment, or are observed with:
- Subjects presenting with acute illness, hospitalization, or drug treatment presented in the last 12 weeks prior to the study selection visit.
- Subjects with symptoms consistent with the definition of a probable case of COVID-19, as well as any subject with a diagnosis of COVID-19.
- Subjects who have had blood transfusions in the last 3 months.
- Regular smokers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thymol200 mg each 8 hours for 90 days | Drug | Group A, Group B |
Primary outcome
Netrin-1
Time frame: Change from baseline netrin-1 at 90 days
Enzyme-Linked ImmunoSorbent Assay
3 secondary outcomes
IL-6
Time frame: Change from baseline IL-6 at 90 days
Adiponectin
Time frame: Change from baseline adiponectin at 90 days
Ultrasensitive C-reactive protein
Time frame: Change from baseline hs-PCR at 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Background: PubMed 30067159Hammarstedt A, Gogg S, Hedjazifar S, Nerstedt A, Smith U. Impaired Adipogenesis and Dysfunctional Adipose Tissue in Human Hypertrophic Obesity. Physiol Rev. 2018 Oct 1;98(4):1911-1941. doi: 10.1152/physrev.00034.2017.
- Background: PubMed 27166942Stern JH, Rutkowski JM, Scherer PE. Adiponectin, Leptin, and Fatty Acids in the Maintenance of Metabolic Homeostasis through Adipose Tissue Crosstalk. Cell Metab. 2016 May 10;23(5):770-84. doi: 10.1016/j.cmet.2016.04.011.
- Background: PubMed 23303904Trayhurn P. Hypoxia and adipose tissue function and dysfunction in obesity. Physiol Rev. 2013 Jan;93(1):1-21. doi: 10.1152/physrev.00017.2012.
- Background: PubMed 23223452Han MS, Jung DY, Morel C, Lakhani SA, Kim JK, Flavell RA, Davis RJ. JNK expression by macrophages promotes obesity-induced insulin resistance and inflammation. Science. 2013 Jan 11;339(6116):218-22. doi: 10.1126/science.1227568. Epub 2012 Dec 6.
- Background: PubMed 21982709Lee KY, Gesta S, Boucher J, Wang XL, Kahn CR. The differential role of Hif1beta/Arnt and the hypoxic response in adipose function, fibrosis, and inflammation. Cell Metab. 2011 Oct 5;14(4):491-503. doi: 10.1016/j.cmet.2011.08.006.
- Background: PubMed 17681149Bouhlel MA, Derudas B, Rigamonti E, Dievart R, Brozek J, Haulon S, Zawadzki C, Jude B, Torpier G, Marx N, Staels B, Chinetti-Gbaguidi G. PPARgamma activation primes human monocytes into alternative M2 macrophages with anti-inflammatory properties. Cell Metab. 2007 Aug;6(2):137-43. doi: 10.1016/j.cmet.2007.06.010.
- Background: PubMed 30532735Yim J, Kim G, Lee BW, Kang ES, Cha BS, Kim JH, Cho JW, Lee SG, Lee YH. Relationship Between Circulating Netrin-1 Concentration, Impaired Fasting Glucose, and Newly Diagnosed Type 2 Diabetes. Front Endocrinol (Lausanne). 2018 Nov 23;9:691. doi: 10.3389/fendo.2018.00691. eCollection 2018.
- Background: PubMed 28694777Nagoor Meeran MF, Javed H, Al Taee H, Azimullah S, Ojha SK. Pharmacological Properties and Molecular Mechanisms of Thymol: Prospects for Its Therapeutic Potential and Pharmaceutical Development. Front Pharmacol. 2017 Jun 26;8:380. doi: 10.3389/fphar.2017.00380. eCollection 2017.
- Background: PubMed 24507296Nieddu M, Rassu G, Boatto G, Bosi P, Trevisi P, Giunchedi P, Carta A, Gavini E. Improvement of thymol properties by complexation with cyclodextrins: in vitro and in vivo studies. Carbohydr Polym. 2014 Feb 15;102:393-9. doi: 10.1016/j.carbpol.2013.10.084. Epub 2013 Nov 20.
- Background: PubMed 28911561Yu YM, Chao TY, Chang WC, Chang MJ, Lee MF. Thymol reduces oxidative stress, aortic intimal thickening, and inflammation-related gene expression in hyperlipidemic rabbits. J Food Drug Anal. 2016 Jul;24(3):556-563. doi: 10.1016/j.jfda.2016.02.004. Epub 2016 Apr 12.
- Background: PubMed 12092740Kohlert C, Schindler G, Marz RW, Abel G, Brinkhaus B, Derendorf H, Grafe EU, Veit M. Systemic availability and pharmacokinetics of thymol in humans. J Clin Pharmacol. 2002 Jul;42(7):731-7. doi: 10.1177/009127002401102678.
- Background: PubMed 29785774Salehi B, Mishra AP, Shukla I, Sharifi-Rad M, Contreras MDM, Segura-Carretero A, Fathi H, Nasrabadi NN, Kobarfard F, Sharifi-Rad J. Thymol, thyme, and other plant sources: Health and potential uses. Phytother Res. 2018 Sep;32(9):1688-1706. doi: 10.1002/ptr.6109. Epub 2018 May 22.
- Individual participant dataSharing planned: No
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria G Ramos-Zavala, PhD study chair
Centro Universitario de Ciencias de la Salud, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thymol in people with Inflammatory Response and Obesity, run by Centro Universitario de Ciencias de la Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria G Ramos-Zavala, PhD (3339523367, ramos.zavala.mg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Netrin-1 (time frame: Change from baseline netrin-1 at 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05427721, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.