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

April 16, 2026 updated by: Blanca Patricia Lazalde Ramos, Universidad Autonoma de Zacatecas

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 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized, placebo-controlled clinical trial aims to evaluate the effects of Rosmarinus officinalis extract on oxidative stress, inflammation, and metabolic parameters in patients with type 2 diabetes. Participants will be randomly assigned to receive either rosemary extract or placebo for a duration of 12 weeks.

Primary outcomes include changes in oxidative stress biomarkers such as malondialdehyde (MDA), antioxidant enzyme activity including superoxide dismutase (SOD), and glutathione (GSH) levels. Secondary outcomes include inflammatory markers such as interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α), as well as metabolic parameters, liver function tests, and renal function biomarkers.

This study seeks to provide scientific evidence on the potential role of Rosmarinus officinalis as a complementary therapeutic strategy to reduce oxidative stress and inflammation in patients with type 2 diabetes.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Zacatecas
      • Zacatecas City, Zacatecas, Mexico, 98160
        • ISSSTE (Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Confirmed diagnosis of T2DM
  2. Older adults over the age of 18.
  3. Signed Informed Consent (Annex 1)
  4. Clinical stability or absence of acute complications associated with diabetes or another disease at the time of the study.
  5. Absence of other associated diseases except Obesity and/or Hypertension
  6. Glomerular filtration rate greater than or equal to 60ml/min/1.73m2 according to the CKD-EPI 2021 formula

Exclusion Criteria:

  1. Allergy or hypersensitivity to any of the components of Rosemary.
  2. Pregnant or breastfeeding women.
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo (control group)
Participants will receive a placebo for 12 weeks.
Other: Placebo
Inactive substance with no therapeutic effect.
Experimental: Rosemary extract
Methanolic extract of Rosmarinus officinalis administered orally.
Dietary supplement: Rosmarinus officinalis extract
Methanolic extract of Rosmarinus officinalis administered orally for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in levels of Glutathione
Time Frame: .Baseline (Day 0) and Month 3
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
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)
Baseline (Day 0), Month 1, Month 2, Month 3
Change in antioxidant enzyme activity of Superoxide Dismutase
Time Frame: Baseline (Day 0) and Month 3
Assessment of superoxide dismutase activity in serum samples. Change in superoxide dismutase (SOD) activity (U/mL)
Baseline (Day 0) and Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum levels of Interleukin-6
Time Frame: Baseline (Day 0) and Month 3
Quantification of IL-6 levels using immunoassay techniques. Change in serum interleukin-6 (IL-6) levels (pg/mL)
Baseline (Day 0) and Month 3
Change in serum levels of Tumor Necrosis Factor Alpha
Time Frame: Baseline (Day 0) and Month 3
Evaluation of TNF-α as a marker of systemic inflammation. Change in serum tumor necrosis factor-alpha (TNF-α) levels (pg/mL)
Baseline (Day 0) and Month 3

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Baseline (Day 0) and End of Intervention (Month 3)
Change in glycated hemoglobin (HbA1c) (%)
Baseline (Day 0) and End of Intervention (Month 3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Zacatecas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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-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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 17, 2026

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI/ISSSTE/2025/043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oxidative Stress

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe