Efficacy of Triticum Aestivum Over Vascular Function in Mexican Obese Patients

Coordinación de Investigación en Salud, Mexico

Status and phase: Completed; Phase 3

Conditions: Obesity; Vascular Risk

Treatments: Drug: calcined magnesia; Drug: Triticum aestivum

Study type: Interventional

Funder types: Other

Identifiers

NCT06950138

R-2023-130-177

Details and patient eligibility

About

This study aims to evaluate the efficacy of Triticum aestivum as a treatment for improving the vascular function in Mexican obese patients. We conducted a triple-blind, randomized, placebo controlled clinical trial, involving obese individuals from the metropolitan area of Guadalajara. The participants were randomly assigned to either Triticum aestivum (intervention group) or placebo supplementation (control). The primary outcome measures were those related with the vascular function using non-invasive methods such as flow-mediated dilation and wave pulse velocity measurements. Secondary outcomes included changes in anthropometric or clinical measures, laboratory results and molecular markers (endothelin-1 and nitric oxide). Data were collected at baseline and after the intervention period. Statistical analyses were performed to determine the significance of the observed changes.

Full description

Background:

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.

Enrollment: 20 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sex indistinct, age between 30 and 60 years, BMI ≥30 and <40 kg/m2, signed informed consent, eumenorrheic women with mechanical or definitive contraceptive method without hormonal treatment.

Exclusion criteria

• History of: liver disease, chronic kidney disease, thyroid disease, cancer, diagnosis of diabetes, hypertension, dyslipidemia, patients with antihypertensive and antidiabetic treatment, lipid-lowering drugs, dietary supplements, acute infectious processes, alcoholism and/or active smoking, current pregnancy or breastfeeding, history of drug intake, recent surgery (in the last 3 months), pacemaker implantation, or any other permanent bioelectronic or metallic element that may modify the bioimpedance reading or may be affected by it.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Triticum aestivum

Active Comparator group

Description:

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.

Calcined magnesia

Placebo Comparator group

Description:

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.

Treatment:

Drug: calcined magnesia