Obesity, Vascular Risk
Conditions
Keywords
Triticum aestivum, Obesity, Arterial stiffness, Flow-mediated dilatation, Wave pulse velocity
Brief summary
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.
Detailed 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.
Interventions
During the intervention period, the aim is to evaluate changes in the patient's vascular function.
During the intervention period, the aim is to evaluate changes in the patient's vascular function.
Sponsors
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Stratified random sampling with a closed envelope, random number assigned by software.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow-mediated dilatation | 12 weeks | Ecosonographic assessment of diameter changes in of the brachial artery secondary to increased blood flow. |
| Wave Pulse Velocity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 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. |
| Medication Adherence | 12 weeks | Voluntary cooperation of the patient in taking drugs or medicine as prescribed. This includes timing, dosage, and frequency. |
| Atherogenic Index | 12 weeks | Logarithmically transformed ratio of molar concentrations of triglycerides to HDL-cholesterol |
| Waist Hip Ratio | 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. |
| Body Max Index | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Endotelin -1 Concentration | 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. |
| Nitric Oxide concentration | 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. |
Countries
Mexico
Outcome results
None listed