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Active (not recruiting) Phase 1 NCT07541729

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

Phase 1 – testing safety in a small group of people
Conditions: Type 2 Diabetes Mellitus (T2DM) Oxidative Stress Inflammation Chronic

Sponsor: Universidad Autonoma de Zacatecas

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Overview
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.
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.
Who can participate
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.
Interventions
Placebo
OTHER
Rosmarinus officinalis extract
DIETARY_SUPPLEMENT
Locations 1
Mexico (1)
ISSSTE (Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado)
Zacatecas City , Zacatecas
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
20.09.2025
Completion date
17.08.2026
Registry ID
NCT07541729
Source
clinicaltrials.gov
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