Efficacy of Triticum Aestivum Over Vascular Function in Mexican Obese Patients

NCT06950138 | Completed Phase 3

• 1 other identifier: R-2023-130-177
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Vascular Risk

Keywords

Triticum aestivum; Obesity; Arterial stiffness; Flow-mediated dilatation; Wave pulse velocity

Outcome Measures

Primary Outcomes (2)

• Wave Pulse Velocity

  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.

  12 weeks

• Flow-mediated dilatation

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

  12 weeks

Secondary Outcomes (5)

• Body Max Index

  12 weeks

• Blood Pressure

  12 weeks

• Waist Hip Ratio

  12 weeks

• Medication Adherence

  12 weeks

• Atherogenic Index

  12 weeks

Other Outcomes (2)

• Endotelin -1 Concentration

  12 weeks

• Nitric Oxide concentration

  12 weeks

Study Arms (2)

Triticum aestivum

ACTIVE COMPARATOR

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

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.

Drug: calcined magnesia

Interventions

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.

Also known as: Magnesium oxide

Calcined magnesia

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

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

Guadalajara, Jalisco, 44380, Mexico

Location

Related Publications (25)

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Related Links

• Cardiovascular Diseases
• What Is Cardiovascular Disease.
• Atención oportuna, fundamental para prevenir y atender enfermedades cardiovasculares.
• Obesity and Overweight.
• Programa de Acción Específico Prevención y Control de la Obesidad y Riesgo Cardiovascular 2013-2018
• Sobrepeso y Obesidad: factores de riesgo para desarrollar diabetes. México.

MeSH Terms

Conditions

Obesity

Interventions

Flour; Magnesium Oxide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Sandra O Hernández González, PhD

  Instituto Mexicano del Seguro Social, Unidad de Investigación Biomédica 02.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Stratified random sampling with a closed envelope, random number assigned by software.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 30, 2025
• Study Start: January 3, 2023
• Primary Completion: January 5, 2025
• Study Completion: February 5, 2025
• Last Updated: April 30, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Starting 6 months after publication.
• Access Criteria: The data can be shared through a request addressed to the principal investigator Dr. Sandra Ofelia Hernández González, basing the reason for what they are requested.

Locations

ME (1)