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Active, Not Recruiting

NCT Number: NCT07541729

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Inflammation Inflammation Chronic Metabolic Diseases Nutritional and Metabolic Diseases Oxidative Stress Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Zacatecas City, Zacatecas, 98160, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Placebo

Other

Inactive substance with no therapeutic effect.

Rosmarinus officinalis extract

Dietary Supplement

Methanolic extract of Rosmarinus officinalis administered orally for 12 weeks

Primary outcomes

  1. 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)

  2. 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)

  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)

Secondary outcomes

  1. 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)

  2. 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)

Other outcomes

  1. HbA1c

    Time frame: Baseline (Day 0) and End of Intervention (Month 3)

    Change in glycated hemoglobin (HbA1c) (%)

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Zacatecas

Other

Registry information

Official study 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.

Acronym: T2DM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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