NCT06950138CompletedPhase 3
Efficacy of Triticum Aestivum Over Vascular Function in Mexican Obese Patients
Source: ClinicalTrials.gov · Last updated 30 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 22 Apr 2025
- Start date
- 3 Jan 2023
- Primary completion date
- 5 Jan 2025
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Diseases
- Obesity
- NCT number
- NCT06950138
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 20
- From 3 Jan 2023 to the primary completion date, 5 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 30 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Speciality, West National Medical Center, Mexican Social Security Institute. Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.