Effect of Rosmarinus Officinalis Extract on Oxidative Stress and Inflammatory Biomarkers in Patients With Type 2 Diabetes (T2DM)

NCT07541729 | Active Not Recruiting DMC

• 1 other identifier: CEI/ISSSTE/2025/043
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Oxidative Stress; Inflammation Chronic

Keywords

Type 2 Diabetes Mellitus; Rosmarinus officinalis; Antioxidants; Rosemary Extract; inflammation; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (7)

• Change in levels of Glutathione (GSH)

  Evaluation of reduced glutathione (GSH) concentration as an indicator of antioxidant status (µmol/L).

  Baseline (Day 0) and Month 3.

• Change in levels of glycated hemoglobin (HbA1c)

  Change in glycated hemoglobin (HbA1c) (%).

  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).

  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).

  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.

  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.

  Baseline (Day 0), Month 1 and Month 3.

• Change in fasting plasma glucose (FPG)

  Change in fasting plasma glucose (mg/dL).

  Baseline (Day 0), Month 3 and Month 6.

Secondary Outcomes (4)

• Change in serum levels of Interleukin-6

  Baseline (Day 0), Month 3, and Month 6.

• Change in serum levels of Tumor Necrosis Factor Alpha

  Baseline (Day 0), Month 3, and Month 6.

• Change in serum Troponin T levels

  Baseline (Day 0), Month 3, and Month 6.

• Change in levels of C-Reactive Protein (CRP)

  Baseline (Day 0), Month 3, and Month 6.

Study Arms (2)

Placebo (control group)

PLACEBO COMPARATOR

Participants will receive a placebo for 12 weeks.

Other: Placebo

Rosemary extract

EXPERIMENTAL

Methanolic extract of Rosmarinus officinalis administered orally.

Dietary Supplement: Rosmarinus officinalis extract

Interventions

Placebo OTHER

Inactive substance with no therapeutic effect.

Placebo (control group)

Rosmarinus officinalis extract DIETARY_SUPPLEMENT

Methanolic extract of Rosmarinus officinalis administered orally for 12 weeks

Rosemary extract

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• \. Patients who are participating in another clinical trial simultaneously.

Sponsors & Collaborators

• Universidad Autonoma de Zacatecas: lead

Study Sites (1)

ISSSTE (Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado)

Zacatecas City, Zacatecas, 98160, Mexico

Location

Related Publications (2)

• 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

  BACKGROUND

• 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.

  PMID: 31909576 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Inflammation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Diana J Soriano Gálvez, M. en C.

  Sin afiliación

  PRINCIPAL INVESTIGATOR

• Sandy F Rodriguez Reyes, Dr.

  Sin afiliación

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to treatment assignment. Both placebo (microcrystalline cellulose) and rosemary extract capsules are identical in appearance, packaging, and labeling, ensuring that participants cannot distinguish which intervention they receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Research Professor at the Autonomous University of Zacatecas (UAZ), Head of Ethnopharmacology Laboratory

Model Details: 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

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 21, 2026
• Study Start: September 20, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)