Status:
RECRUITING
Effect of Triticum Aestivum on Appetite, Ghrelin, Leptin, Adiponectin Hormonal Axis in Patients With Obesity
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Conditions:
Obesity
Leptin Deficiency
Eligibility:
All Genders
30-50 years
Phase:
PHASE3
Brief Summary
Obesity represents one of the major health problems worldwide; it is clear that current approaches to address obesity are largely unsuccessful. The endocrine axis of leptin and ghrelin acts as the cri...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 processes Alcoholism 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).
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 24 2024
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06496100
Start Date
January 3 2024
End Date
December 24 2024
Last Update
July 11 2024
Active Locations (1)
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1
Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Specialty, West National Medical Center, Mexican Social Security Institute.
Guadalajara, Jalisco, Mexico, 44380