Logo 1 Logo 2

Clinical Trial Details

Trial ID: L1811
Source ID: NCT06501248
Associated Drug: Triticum Aestivum
Title: Effect of Triticum Aestivum vs Placebo on Metabolic Profile Components and Insulin Sensitivity in Patients With Obesity
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Obesity|Drug Effect|Insulin Sensitivity
Interventions: DRUG: Triticum Aestivum|DRUG: Placebo (calcined magnesia)
Outcome Measures: Primary: The effect of Triticum aestivum on glucose in patients with obesity, Changes in levels of glucose in mg/dl., 120 days|The effect of Triticum aestivum on insulin sensitivity in patients with obesity, Changes in levels of insulin sensitivity in the triglyceride and glucose index (natural logarithm ((glucose in mg/dl \* triglycerides in mg/dl)/2)), 120 days|The effect of Triticum aestivum on high-density lipoprotein cholesterol in patients with obesity, Changes in levels of high-density lipoprotein in mg/dl., 120 days|The effect of Triticum aestivum on low-density lipoprotein cholesterol in patients with obesity, Changes in levels of low-density lipoprotein cholesterol in mg/dl., 120 days|The effect of Triticum aestivum on very low-density lipoprotein cholesterol in patients with obesity, Changes in levels of very low-density lipoprotein cholesterol in mg/dl., 120 days|The effect of Triticum aestivum on total cholesterol in patients with obesity, Changes in levels of total cholesterol in mg/dl., 120 days|The effect of Triticum aestivum on triglycerides in patients with obesity, Changes in levels of triglycerides in mg/dl., 120 days|The effect of Triticum aestivum on body weight in patients with obesity, Changes in levels of body weight in kilograms., 120 days|The effect of Triticum aestivum on Body Mass Index in patients with obesity, Changes in levels of Body Mass Index (weight in kilograms / (height in meters squared)), 120 days|The effect of Triticum aestivum on fat percentage in patients with obesity, Changes in levels of fat percentage (percentage), 120 days|The effect of Triticum aestivum on Waist Hip Index in patients with obesity, Changes in levels of Waist Hip Index (waist in centimeters / hip in centimeters), 120 days | Secondary: The effect of Triticum aestivum on blood pressure in patients with obesity, Changes in levels of blood pressure in mmHg., 120 days|The effect of Triticum aestivum on renal profile in patients with obesity, Changes in levels of creatinine in mg/dl., 120 days|The effect of Triticum aestivum on hepatic profile in patients with obesity, Changes in levels of Alanine aminotransferase in mg/dl and Aspartate aminotransferase in mg/dl, 120 days
Sponsor/Collaborators: Sponsor: Coordinación de Investigación en Salud, Mexico
Gender: ALL
Age: ADULT
Phases: PHASE3
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-07-14
Completion Date: 2024-12-10
Results First Posted:
Last Update Posted: 2024-07-15
Locations: Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Specialty, West National Medical Center, Mexican Social Security Institute., Guadalajara, Jalisco, 44380, Mexico
URL: https://clinicaltrials.gov/show/NCT06501248