Type 2 Diabetes Mellitus (T2DM)T2DMNCT07541729
Effect of Rosmarinus Officinalis Extract on Oxidative Stress and Inflammatory Biomarkers in Patients With Type 2 Diabetes (T2DM)
A study testing Rosmarinus officinalis extract in people with Type 2 Diabetes Mellitus (T2DM) and Oxidative Stress, run by Universidad Autonoma de Zacatecas at 1 site in Mexico.
Trial summary
This randomized, placebo-controlled clinical trial evaluates the effects of a methanolic extract of Rosmarinus officinalis (rosemary) in patients with type 2 diabetes mellitus. Participants are randomly assigned to receive either methanolic rosemary extract or placebo in addition to their usual treatment and are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Oxidative Stress, Inflammation Chronic
- What is being tested?
- Rosmarinus officinalis extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 20 Sep 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of T2DM
- Older adults over the age of 18.
- Signed Informed Consent (Annex 1)
- Clinical stability or absence of acute complications associated with diabetes or another disease at the time of the study.
- Absence of other associated diseases except Obesity and/or Hypertension
- Glomerular filtration rate greater than or equal to 60ml/min/1.73m2 according to the CKD-EPI 2021 formula
Who cannot join
- Allergy or hypersensitivity to any of the components of Rosemary.
- Pregnant or breastfeeding women.
- Patients who are taking other supplements or medications that may interfere with the study results. (antioxidants)
- 5. Patients who are participating in another clinical trial simultaneously.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
ISSSTE (Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado)
Zacatecas City, Zacatecas, 98160
About this study
Official title: Randomized Controlled Trial Evaluating the Effect of Rosmarinus Officinalis Extract on Metabolic, Hepatic, Renal, Inflammatory, and Oxidative Stress Biomarkers in Patients With Type 2 Diabetes.
This randomized, placebo-controlled clinical trial evaluates the effects of a methanolic extract of Rosmarinus officinalis (rosemary) in patients with type 2 diabetes mellitus. Participants are randomly assigned to receive either methanolic rosemary extract or placebo in addition to their usual treatment and are followed for six months. A data cut-off at Month 3 is used for the analysis of metabolic, oxidative stress, and cytogenetic outcomes, while selected inflammatory and cardiovascular biomarkers continue to be assessed through Month 6. The study investigates the potential complementary effects of methanolic rosemary extract on metabolic control, oxidative stress, inflammation, genomic stability, and cardiovascular-related biomarkers in patients with type 2 diabetes mellitus.
Read the detailed description
This randomized, placebo-controlled clinical trial evaluates the effects of a methanolic extract of Rosmarinus officinalis (rosemary) in patients with type 2 diabetes mellitus. Participants are randomly assigned to receive either methanolic rosemary extract or placebo in addition to their usual treatment and are followed for six months. A data cut-off at Month 3 is used for the analysis of metabolic, oxidative stress, and cytogenetic outcomes, while selected inflammatory and cardiovascular biomarkers continue to be assessed through Month 6.
The study evaluates changes in metabolic parameters, including fasting serum glucose and glycated hemoglobin (HbA1c); oxidative stress and antioxidant biomarkers, including malondialdehyde (MDA), superoxide dismutase (SOD), and reduced glutathione (GSH); and inflammatory biomarkers, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and C-reactive protein (CRP).
Cytogenetic outcomes are assessed in exfoliated buccal epithelial cells using the buccal micronucleus cytome (BMCyt) assay. These outcomes include micronuclei and other nuclear abnormalities associated with genomic damage and cytotoxicity. Cytogenetic assessments are performed at baseline (Day 0), Month 1, and Month 3.
Selected inflammatory and cardiovascular biomarkers are assessed at baseline, Month 3, and Month 6. These include IL-6, TNF-α, CRP, and Troponin T, allowing evaluation of inflammatory and cardiovascular-related changes during the extended follow-up period.
Overall, the study aims to investigate the potential complementary effects of methanolic Rosmarinus officinalis extract on metabolic control, oxidative stress, inflammation, genomic stability, and cardiovascular-related biomarkers in patients with type 2 diabetes mellitus.
- Being tested
- Placebo, Rosmarinus officinalis extract
- Keywords
- Type 2 Diabetes Mellitus, Rosmarinus officinalis, Antioxidants, Rosemary Extract, inflammation, Randomized Controlled Trial
- Medical subject headings
- Diabetes Mellitus, Type 2, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Inactive substance with no therapeutic effect.
Rosmarinus officinalis extractDietary supplement
Methanolic extract of Rosmarinus officinalis administered orally for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo (control group) | Placebo comparator | Participants will receive a placebo for 12 weeks. Receives: Other: Placebo |
| Rosemary extract | Experimental | Methanolic extract of Rosmarinus officinalis administered orally. Receives: Dietary Supplement: Rosmarinus officinalis extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of Glutathione (GSH)
Evaluation of reduced glutathione (GSH) concentration as an indicator of antioxidant status (µmol/L).
Measured: Baseline (Day 0) and Month 3.
Change in levels of glycated hemoglobin (HbA1c)
Change in glycated hemoglobin (HbA1c) (%).
Measured: Baseline (Day 0) and Month 3.
Change in serum levels of Malondialdehyde (MDA)
Measurement of serum malondialdehyde concentration as a marker of lipid peroxidation and oxidative stress.
Change in serum malondialdehyde (MDA) levels (nmol/mL).
Measured: Baseline (Day 0), Month 1, Month 2, Month 3.
Change in antioxidant enzyme activity of Superoxide Dismutase (SOD)
Assessment of superoxide dismutase activity in serum samples. Change in superoxide dismutase (SOD) activity (U/mL).
Measured: Baseline (Day 0) and Month 3.
Change in the frequency of micronuclei and nuclear buds in buccal epithelial cells
Change in the frequency of micronucleated cells and cells with nuclear buds in exfoliated buccal epithelial cells assessed using the buccal micronucleus cytome (BMCyt) assay. Results are expressed as the number of cells presenting micronuclei or nuclear buds per 2,000 cells evaluated.
Measured: Baseline (Day 0), Month 1 and Month 3.
Change in the frequency of nuclear abnormalities in buccal epithelial cells
Change in the frequency of nuclear abnormalities assessed using the BMCyt assay, including binucleated cells, condensed chromatin, karyorrhexis, pyknosis, and karyolysis. Results are expressed as the number of cells presenting each nuclear abnormality per 2,000 evaluated cells.
Measured: Baseline (Day 0), Month 1 and Month 3.
Change in fasting plasma glucose (FPG)
Change in fasting plasma glucose (mg/dL).
Measured: Baseline (Day 0), Month 3 and Month 6.
Secondary outcomes (4)
Change in serum levels of Interleukin-6
Quantification of IL-6 levels using immunoassay techniques. Change in serum interleukin-6 (IL-6) levels (pg/mL).
Measured: Baseline (Day 0), Month 3, and Month 6.
Change in serum levels of Tumor Necrosis Factor Alpha
Evaluation of TNF-α as a marker of systemic inflammation. Change in serum tumor necrosis factor-alpha (TNF-α) levels (pg/mL).
Measured: Baseline (Day 0), Month 3, and Month 6.
Change in serum Troponin T levels
Change in serum Troponin T concentration as a biomarker of cardiovascular involvement. Troponin T will be measured using an enzyme immunoassay according to the manufacturer's instructions (pg/mL).
Measured: Baseline (Day 0), Month 3, and Month 6.
Change in levels of C-Reactive Protein (CRP)
Evaluation of CRP as a marker of systemic inflammation. Change in serum CRP levels (pg/mL).
Measured: Baseline (Day 0), Month 3, and Month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start20 Sep 2025
- Primary completion1 Jun 2026
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups of 20 participants each. One group receives 500 mg of placebo (microcrystalline cellulose) daily, and the other group receives 500 mg of methanolic rosemary extract daily. The intervention lasts for 12 weeks
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Zacatecas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanca Patricia Lazalde Ramos, Universidad Autonoma de Zacatecas
- Investigators
- Diana J Soriano Gálvez, M. en C., Principal investigator, Sin afiliaciónSandy F Rodriguez Reyes, Dr., Principal investigator, Sin afiliación
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541729
- Sponsor's protocol ID
- CEI/ISSSTE/2025/043
- Acronym
- T2DM
- Status last verified
- Aug 2026
- First submitted
- 17 Mar 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodríguez, J. M., Lazalde Ramos, B. P., Galván Valencia, M., & Quirarte Báez, S. M. (2025). Propiedades Terapéuticas del Romero (Rosmarinus officinalis L.) en el Manejo de la Diabetes Mellitus 2, Perspectivas Metabólicas y Clínicas: Una Revisión Bibliográfica. Ciencia Latina Revista Científica Multidisciplinar, 9(3), 8630-8648. https://doi.org/10.37811/cl_rcm.v9i4.18494
Quirarte-Baez SM, Zamora-Perez AL, Reyes-Estrada CA, Gutierrez-Hernandez R, Sosa-Macias M, Galaviz-Hernandez C, Manriquez GGG, Lazalde-Ramos BP. A shortened treatment with rosemary tea (rosmarinus officinalis) instead of glucose in patients with diabetes mellitus type 2 (TSD). J Popul Ther Clin Pharmacol. 2019 Dec 3;26(4):e18-e28. doi: 10.15586/jptcp.v26i4.634.
PubMed 31909576
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating the Effect of Rosmarinus Officinalis Extract on Metabolic, Hepatic, Renal, Inflammatory, and Oxidative Stress Biomarkers in Patients With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT07541729
- Acronym / sponsor ID
- T2DM / CEI/ISSSTE/2025/043
- Keywords
- Type 2 Diabetes Mellitus, Rosmarinus officinalis, Antioxidants, Rosemary Extract, inflammation, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Autonoma de ZacatecasUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Apr 2026 (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.
This randomized, placebo-controlled clinical trial evaluates the effects of a methanolic extract of Rosmarinus officinalis (rosemary) in patients with type 2 diabetes mellitus. Participants are randomly assigned to receive either methanolic rosemary extract or placebo in addition to their usual treatment and are followed for six months. A data cut-off at Month 3 is used for the analysis of metabolic, oxidative stress, and cytogenetic outcomes, while selected inflammatory and cardiovascular biomarkers continue to be assessed through Month 6. The study investigates the potential complementary effects of methanolic rosemary extract on metabolic control, oxidative stress, inflammation, genomic stability, and cardiovascular-related biomarkers in patients with type 2 diabetes mellitus.
Detailed description
This randomized, placebo-controlled clinical trial evaluates the effects of a methanolic extract of Rosmarinus officinalis (rosemary) in patients with type 2 diabetes mellitus. Participants are randomly assigned to receive either methanolic rosemary extract or placebo in addition to their usual treatment and are followed for six months. A data cut-off at Month 3 is used for the analysis of metabolic, oxidative stress, and cytogenetic outcomes, while selected inflammatory and cardiovascular biomarkers continue to be assessed through Month 6.
The study evaluates changes in metabolic parameters, including fasting serum glucose and glycated hemoglobin (HbA1c); oxidative stress and antioxidant biomarkers, including malondialdehyde (MDA), superoxide dismutase (SOD), and reduced glutathione (GSH); and inflammatory biomarkers, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and C-reactive protein (CRP).
Cytogenetic outcomes are assessed in exfoliated buccal epithelial cells using the buccal micronucleus cytome (BMCyt) assay. These outcomes include micronuclei and other nuclear abnormalities associated with genomic damage and cytotoxicity. Cytogenetic assessments are performed at baseline (Day 0), Month 1, and Month 3.
Selected inflammatory and cardiovascular biomarkers are assessed at baseline, Month 3, and Month 6. These include IL-6, TNF-α, CRP, and Troponin T, allowing evaluation of inflammatory and cardiovascular-related changes during the extended follow-up period.
Overall, the study aims to investigate the potential complementary effects of methanolic Rosmarinus officinalis extract on metabolic control, oxidative stress, inflammation, genomic stability, and cardiovascular-related biomarkers in patients with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two parallel groups of 20 participants each. One group receives 500 mg of placebo (microcrystalline cellulose) daily, and the other group receives 500 mg of methanolic rosemary extract daily. The intervention lasts for 12 weeks
| Arm | Type | Receives |
|---|---|---|
| Placebo (control group) | Placebo comparator | Other: PlaceboParticipants will receive a placebo for 12 weeks. |
| Rosemary extract | Experimental | Dietary Supplement: Rosmarinus officinalis extractMethanolic extract of Rosmarinus officinalis administered orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of T2DM
- Older adults over the age of 18.
- Signed Informed Consent (Annex 1)
- Clinical stability or absence of acute complications associated with diabetes or another disease at the time of the study.
- Absence of other associated diseases except Obesity and/or Hypertension
Key exclusion criteria (4 listed)
- Allergy or hypersensitivity to any of the components of Rosemary.
- Pregnant or breastfeeding women.
- Patients who are taking other supplements or medications that may interfere with the study results. (antioxidants)
- 5. Patients who are participating in another clinical trial simultaneously.
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 |
|---|---|---|
| PlaceboInactive substance with no therapeutic effect. | Other | Placebo (control group) |
| Rosmarinus officinalis extractMethanolic extract of Rosmarinus officinalis administered orally for 12 weeks | Dietary supplement | Rosemary extract |
Primary outcome
Change in levels of Glutathione (GSH)
Time frame: Baseline (Day 0) and Month 3.
Evaluation of reduced glutathione (GSH) concentration as an indicator of antioxidant status (µmol/L).
Change in levels of glycated hemoglobin (HbA1c)
Time frame: Baseline (Day 0) and Month 3.
Change in glycated hemoglobin (HbA1c) (%).
Change in serum levels of Malondialdehyde (MDA)
Time frame: Baseline (Day 0), Month 1, Month 2, Month 3.
Measurement of serum malondialdehyde concentration as a marker of lipid peroxidation and oxidative stress. Change in serum malondialdehyde (MDA) levels (nmol/mL).
Change in antioxidant enzyme activity of Superoxide Dismutase (SOD)
Time frame: Baseline (Day 0) and Month 3.
Assessment of superoxide dismutase activity in serum samples. Change in superoxide dismutase (SOD) activity (U/mL).
Change in the frequency of micronuclei and nuclear buds in buccal epithelial cells
Time frame: Baseline (Day 0), Month 1 and Month 3.
Change in the frequency of micronucleated cells and cells with nuclear buds in exfoliated buccal epithelial cells assessed using the buccal micronucleus cytome (BMCyt) assay. Results are expressed as the number of cells presenting micronuclei or nuclear buds per 2,000 cells evaluated.
Change in the frequency of nuclear abnormalities in buccal epithelial cells
Time frame: Baseline (Day 0), Month 1 and Month 3.
Change in the frequency of nuclear abnormalities assessed using the BMCyt assay, including binucleated cells, condensed chromatin, karyorrhexis, pyknosis, and karyolysis. Results are expressed as the number of cells presenting each nuclear abnormality per 2,000 evaluated cells.
Change in fasting plasma glucose (FPG)
Time frame: Baseline (Day 0), Month 3 and Month 6.
Change in fasting plasma glucose (mg/dL).
4 secondary outcomes
Change in serum levels of Interleukin-6
Time frame: Baseline (Day 0), Month 3, and Month 6.
Change in serum levels of Tumor Necrosis Factor Alpha
Time frame: Baseline (Day 0), Month 3, and Month 6.
Change in serum Troponin T levels
Time frame: Baseline (Day 0), Month 3, and Month 6.
Change in levels of C-Reactive Protein (CRP)
Time frame: Baseline (Day 0), Month 3, and Month 6.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- BackgroundRodríguez, J. M., Lazalde Ramos, B. P., Galván Valencia, M., & Quirarte Báez, S. M. (2025). Propiedades Terapéuticas del Romero (Rosmarinus officinalis L.) en el Manejo de la Diabetes Mellitus 2, Perspectivas Metabólicas y Clínicas: Una Revisión Bibliográfica. Ciencia Latina Revista Científica Multidisciplinar, 9(3), 8630-8648. https://doi.org/10.37811/cl_rcm.v9i4.18494
- Background: PubMed 31909576Quirarte-Baez SM, Zamora-Perez AL, Reyes-Estrada CA, Gutierrez-Hernandez R, Sosa-Macias M, Galaviz-Hernandez C, Manriquez GGG, Lazalde-Ramos BP. A shortened treatment with rosemary tea (rosmarinus officinalis) instead of glucose in patients with diabetes mellitus type 2 (TSD). J Popul Ther Clin Pharmacol. 2019 Dec 3;26(4):e18-e28. doi: 10.15586/jptcp.v26i4.634.
- Individual participant dataSharing planned: No
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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.
Diana J Soriano Gálvez, M. en C. principal investigator
Sin afiliación
Sandy F Rodriguez Reyes, Dr. principal investigator
Sin afiliación
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosmarinus officinalis extract in people with Type 2 Diabetes Mellitus (T2DM) and Oxidative Stress, run by Universidad Autonoma de Zacatecas 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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of Glutathione (GSH) (time frame: Baseline (Day 0) and Month 3.). The study lists 7 primary outcomes in all. 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 NCT07541729, which also lists 2 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 26 Aug 2026.