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

Universidad Autonoma de Zacatecas

Status and phase: Active, not recruiting; Phase 1

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

Treatments: Other: Placebo; Dietary Supplement: Rosmarinus officinalis extract

Study type: Interventional

Funder types: Other

Identifiers

NCT07541729

CEI/ISSSTE/2025/043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Placebo (control group)

Placebo Comparator group

Description:

Participants will receive a placebo for 12 weeks.

Treatment:

Other: Placebo

Rosemary extract

Experimental group

Description:

Methanolic extract of Rosmarinus officinalis administered orally.

Treatment:

Dietary Supplement: Rosmarinus officinalis extract