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

NCT07541729 | Active Not Recruiting Phase 1 DMC

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

Brief Summary

This study will evaluate the effects of Rosmarinus officinalis (rosemary) extract on oxidative stress and inflammation in patients with type 2 diabetes. Participants will be randomly assigned to receive either rosemary extract or a placebo for 12 weeks. The study aims to determine whether rosemary extract can improve health markers related to oxidative stress, inflammation, and metabolic function.

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 (3)

• Change in levels of Glutathione

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

  .Baseline (Day 0) and Month 3

• Change in serum levels of Malondialdehyde

  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

  Assessment of superoxide dismutase activity in serum samples. Change in superoxide dismutase (SOD) activity (U/mL)

  Baseline (Day 0) and Month 3

Secondary Outcomes (2)

• Change in serum levels of Interleukin-6

  Baseline (Day 0) and Month 3

• Change in serum levels of Tumor Necrosis Factor Alpha

  Baseline (Day 0) and Month 3

Other Outcomes (1)

• HbA1c

  Baseline (Day 0) and End of Intervention (Month 3)

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-Báez, S. M., Zamora-Perez, A. L., Reyes-Estrada, C. A., Gutiérrez-Hernández, R., Sosa-Macías, M., Galaviz-Hernández, C., Guerrero Manríquez, G. G., & Lazalde-Ramos, B. P. (2019). A shortened treatment with rosemary tea (rosmarinus officinalis) instead of glucose in patients with diabetes mellitus type 2 (TSD). Journal of Population Therapeutics and Clinical Pharmacology, 26(4), e18-e28. https://doi.org/10.15586/jptcp.v26i4.634

  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 Design

• Study Type: interventional
• Phase: phase 1
• 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 (Estimated): June 1, 2026
• Study Completion (Estimated): August 17, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)