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Completed

NCT Number: NCT06950138

Efficacy of Triticum Aestivum Over Vascular Function in Mexican Obese Patients

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.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Speciality, West National Medical Center, Mexican Social Security Institute.

Guadalajara, Jalisco, 44380, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Triticum aestivum

Drug

During the intervention period, the aim is to evaluate changes in the patient's vascular function.

calcined magnesia

Drug

During the intervention period, the aim is to evaluate changes in the patient's vascular function.

Other names: Magnesium oxide

Primary outcomes

  1. Wave Pulse Velocity

    Time frame: 12 weeks

    The transit time of an aortic pressure wave between the common carotid artery and the common femoral artery. It is a standard measure of arterial stiffness.

  2. Flow-mediated dilatation

    Time frame: 12 weeks

    Ecosonographic assessment of diameter changes in of the brachial artery secondary to increased blood flow.

Secondary outcomes

  1. Body Max Index

    Time frame: 12 weeks

    An indicator of body density as determined by the relationship of body weight to body height. BMI=weight (kg)/height squared (m2). BMI correlates with body fat (adipose tissue). Their relationship varies with age and gender. For adults, BMI falls into these categories: below 18.5 (underweight); 18.5-24.9 (normal); 25.0-29.9 (overweight); 30.0 and above (obese).

  2. Blood Pressure

    Time frame: 12 weeks

    The blood pressure in the arteries. It is commonly measured with a sphygmomanometer on the upper arm which represents the arterial pressure in the brachial artery.

  3. Waist Hip Ratio

    Time frame: 12 weeks

    The waist circumference measurement divided by the hip circumference measurement. For both men and women, a waist-to-hip ratio (WHR) of 1.0 or higher is considered "at risk" for undesirable health consequences, such as heart disease and ailments associated with overweight. A healthy WHR is 0.90 or less for men, and 0.80 or less for women.

  4. Medication Adherence

    Time frame: 12 weeks

    Voluntary cooperation of the patient in taking drugs or medicine as prescribed. This includes timing, dosage, and frequency.

  5. Atherogenic Index

    Time frame: 12 weeks

    Logarithmically transformed ratio of molar concentrations of triglycerides to HDL-cholesterol

Other outcomes

  1. Endotelin -1 Concentration

    Time frame: 12 weeks

    Plasma concentration of A 21-amino acid peptide produced in a variety of tissues including endothelial and vascular smooth-muscle cells, neurons and astrocytes in the central nervous system, and endometrial cells. It acts as a modulator of vasomotor tone, cell proliferation, and hormone production.

  2. Nitric Oxide concentration

    Time frame: 12 weeks

    Plasma concentration of A free radical gas produced endogenously by a variety of mammalian cells, synthesized from arginine by nitric oxide synthase. Nitric oxide is one of the endothelium-dependent relaxing factors released by the vascular endothelium and mediates vasodilation. It also inhibits platelet aggregation, induces disaggregation of aggregated platelets, and inhibits platelet adhesion to the vascular endothelium. Nitric oxide activates cytosolic guanylate cyclase and thus elevates intracellular levels of cyclic GMP.

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

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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