Last updated 5 months ago
Effect of Triticum Aestivum on Appetite, Ghrelin, Leptin, Adiponectin Hormonal Axis in Patients With Obesity
38 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.
Two parallel groups, with randomization by software using envelopes, will require a total
of 38 patients, which will be distributed as follows: 1) A group of 19 patients with a
diagnosis of obesity without pharmacological or surgical treatment, who will receive 500
mg capsules with lyophilized Triticum aestivum orally every 12 hours for 120 days, and 2)
A group of 19 patients with a diagnosis of obesity without pharmacological or surgical
treatment, who will receive 500 mg capsules of placebo (calcined magnesia) orally every
12 hours for 120 days.
Coordinación de Investigación en Salud, Mexico
38Patients around the world
This study is for people with
Obesity
Requirements for the patient
To 50 Years
All Gender
Medical requirements
- People of any sex (eumenorrheic women with mechanical or definitive contraceptive method without hormonal treatment).Age from 30 to 50 years old.Residents of the metropolitan area of Guadalajara.Signed informed consent form.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.
- Diagnosis of diabetes and dyslipidemia.Diagnosis of anxiety and/or depression.History of: liver disease, chronic kidney disease, thyroid disease, cancer.Antidiabetic treatment, lipid-lowering, food supplements, antidepressants, corticosteroids.Acute infectious processesAlcoholism and/or active smoking in any intensity within the 12 months prior to the start of the study.Suspected or confirmed pregnancy or breastfeeding.History of drug intake.Recent surgery (<3 months)Carrying a pacemaker, or any other bioelectronic or metallic element.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 per day.Intake of anorexigenic drugs, hypolipidemic drugs or drugs with effect on body weight.History of any type of cancer, hyperthyroidism, hypothyroidism, renal disease, liver disease and pancreatic disease.History of hypersensitivity to the study drug (gluten).
SponsorCoordinación de Investigación en Salud, Mexico
Conditions
Obesity
Requirements
To 50 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06496100
