Last updated 2 years ago
Effect of Triticum Aestivum vs Placebo on Metabolic Profile Components and Insulin Sensitivity in Patients With Obesity
36 patients around the world
Available in Mexico
A double-blind clinical trial is proposed, with two parallel groups, with random assignment and group control. The universe of the sample will be patients with a diagnosis of obesity, residents of the Guadalajara Metropolitan Area, who agree to participate by signing informed consent and can go to the Biomedical Unit 02 of the Mexican Institute of Social Security. A total of 36 patients will be followed, which will be distributed as follows: 1) A group of 18 patients with a diagnosis of obesity without pharmacological or emergency treatment, who will receive 500 mg of triticum aestivum orally every 12 hours for 120 days, and 2) A group of 18 patients diagnosed with obesity without pharmacological or surgical treatment, who will receive 500 mg of placebo (calcined magnesia) orally every 12 days for 120 days.
Coordinación de Investigación en Salud, Mexico
1Research sites
36Patients around the world
This study is for people with
Obesity
Requirements for the patient
To 50 Years
All Gender
Medical requirements
- Ability to communicate and meet all study requirements.People who sign the consent under written information prior to carrying out any procedure.People of any sex, (eumenorrheic women with mechanical or definitive contraceptive method without hormonal treatment) Mexicans from 30 to 50 years of age, residents of Guadalajara, Jalisco, beneficiaries of the Instituto Mexicano del Seguro Social (IMSS).People with a diagnosis of Obesity (BMI ≥30 - 39.9 kg/m2), stable body weight within the 3 months prior to the start of the study, defined as a variability in body weight of less than 5%.Fasting glucose <126 mg/dl.Cholesterol <240 mg/dl.Triglycerides <300 mg/dl.Resting systolic blood pressure less than 140 mmHg with resting diastolic blood pressure less than 90 mmHg.
- Suspected or confirmed pregnancy.Women breastfeeding or in the postpartum or postpartum period.History of smoking at any intensity within the 12 months prior to the start of the study.Excessive sedentary lifestyle defined as physical activity less than the equivalent of 15 minutes of walking per day.Excessive exercise, defined as physical activity equivalent to running for 60 minutes a day.Intake of drugs that are anorexigenic, lipid-lowering or have an effect on body weight.History of any type of cancer, hyperthyroidism, hypothyroidism, kidney disease, liver disease, and pancreatic disease.History of hypersensitivity to the study drug (gluten).History of drug intake.Carrying of a pacemaker, or any other permanent bioelectronic element that can modify the electrical bioimpedance reading or can be affected by it.Patients diagnosed with Morbid Obesity (BMI ≥ 40 kg/m2).
Sites
Omega Salud Investigación
Recruiting
SponsorCoordinación de Investigación en Salud, Mexico
Conditions
Obesity
Requirements
To 50 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06501248
