Status:
UNKNOWN
Effect of Triticum Aestivum vs Placebo on Metabolic Profile Components and Insulin Sensitivity in Patients With Obesity
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Conditions:
Obesity
Drug Effect
Eligibility:
All Genders
30-50 years
Phase:
PHASE3
Brief Summary
Obesity is a metabolic disease which has been declared as the most prevalent chronic health problem in adults; according to the World Health Organization (WHO), it is defined as an increase in Body Ma...
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
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
July 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06501248
Start Date
July 14 2022
End Date
December 10 2024
Last Update
July 15 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