Efficacy of Triticum Aestivum Over Vascular Function in Mexican Obese Patients
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Wave Pulse Velocity
Study Overview
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Stratified random sampling with a closed envelope, random number assigned by software.
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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.
Intervention: calcined magnesia (Drug)
Outcomes
Primary Outcomes
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.
Flow-mediated dilatation
Time Frame: 12 weeks
Ecosonographic assessment of diameter changes in of the brachial artery secondary to increased blood flow.
Secondary Outcomes
- Atherogenic Index(12 weeks)
- Body Max Index(12 weeks)
- Blood Pressure(12 weeks)
- Waist Hip Ratio(12 weeks)
- Medication Adherence(12 weeks)