Efficacy of Triticum Aestivum Over Vascular Function in Mexican Obese Patients
NCT ID: NCT06950138
Last Updated: 2025-04-30
Study Results
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Basic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2023-01-03
2025-02-05
Brief Summary
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Detailed Description
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Obesity is a multifactorial disease highly prevalent among Mexican population. It is closely related to the maintenance of a pro-inflammatory syndrome. This promotes the development of physiopathological mechanisms that support and perpetuate the vascular disfunction which can contribute to the development of cardiovascular disease.
The vascular disfunction is closely related to the impaired endothelial function and increase arterial stiffness. Currently there is no specific treatment for vascular disfunction. Triticum aestivum, or wheatgrass, is a known plant, used primary for its anti-inflammatory and antioxidant properties. This trial aim to investigate the potential health benefits in vascular function of Mexican obese patients. Triticum aestivum is rich in fibers, vitamins, minerals, and polyphenols. Polyphenols, such as flavonoids have antioxidant and anti-inflammatory properties. The flavonoids in wheat grass can scavenge free radicals, preventing cellular damage and preserving endothelial function. In addition, flavonoids have demonstrated anti-inflammatory effects, modulating inflammatory processes within the vascular system. Moreover, the flavonoids can contribute to a improve lipid profile by reducing low density cholesterol levels.
Objetive:
Evaluate the efficacy of Triticum aestivum versus placebo over the vascular function of Mexican obese patients.
Study Design:
A randomized, triple-blind, placebo-controlled clinical trial in Mexican patients with obesity from the metropolitan area of Guadalajara diagnosed according to WHO criteria, who agreed to participate in the protocol through informed consent, randomly assigned to two groups: an intervention group that will receive 1 capsule of 500 mg of Triticum aestivum every 12 hours for 120 days (n=10), and a control group that will receive placebo with the same organoleptic characteristics for the same period of time (n=10).
Participants:
20 Mexican patients with obesity from the metropolitan area of Guadalajara diagnosed according to WHO criteria (BMI between ≥30 and \<40 kg/m2), both sexes, who agreed to participate in the protocol through informed consent, with no known co-mobilities, use of current medication or any contraindication.
Intervention:
Intervention group that received 1 capsule of 500 mg of Triticum aestivum every 12 hours for 120 days (n=10), and a control group that received placebo with the same organoleptic characteristics for the same period (n=10). Both groups received general lifestyle and dietary recommendations.
Outcome Measures:
Primary outcome measures included flow-mediated dilation and arterial stiffness assessed by wave pulse velocity using non-invasive techniques. Secondary outcome measures encompassed anthropometric and clinical parameters, as well as laboratory results, and molecular markers such as endothelin-1 and nitric oxide.
Data Collection:
Baseline and post-intervention data were collected through standardized assessments and laboratory tests.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Triticum aestivum
A group of 20 patients with a diagnosis of obesity without current treatment or other associated pathologies, who will receive 500 mg of triticum aestivum orally every 12 hours for 120 days.
No interventions assigned to this group
Calcined magnesia
A group of 20 patients with a diagnosis of obesity without current treatment or other associated pathologies, who will recive 500 mg of calcined magnesia oraly every 12 hours for 120 days.
calcined magnesia
During the intervention period, the aim is to evaluate changes in the patient's vascular function.
Interventions
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Triticum aestivum
During the intervention period, the aim is to evaluate changes in the patient's vascular function.
calcined magnesia
During the intervention period, the aim is to evaluate changes in the patient's vascular function.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
30 Years
60 Years
ALL
No
Sponsors
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Coordinación de Investigación en Salud, Mexico
OTHER_GOV
Responsible Party
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Principal Investigators
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Sandra O Hernández González, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Mexicano del Seguro Social, Unidad de Investigación Biomédica 02.
Locations
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Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Speciality, West National Medical Center, Mexican Social Security Institute.
Guadalajara, Jalisco, Mexico
Countries
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References
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Related Links
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Cardiovascular Diseases
What Is Cardiovascular Disease.
Atención oportuna, fundamental para prevenir y atender enfermedades cardiovasculares.
Obesity and Overweight.
Programa de Acción Específico Prevención y Control de la Obesidad y Riesgo Cardiovascular 2013-2018
Sobrepeso y Obesidad: factores de riesgo para desarrollar diabetes. México.
Other Identifiers
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R-2023-130-177
Identifier Type: -
Identifier Source: org_study_id
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