Effect of Triticum Aestivum vs Placebo on Metabolic Profile Components and Insulin Sensitivity in Patients With Obesity
NCT Number: NCT06501248
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Obesity|Drug Effect|Insulin Sensitivity
Interventions: DRUG: Triticum Aestivum|DRUG: Placebo (calcined magnesia)
Sponsor: Coordinación de Investigación en Salud, Mexico
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-07-14
Completion Date: 2024-12-10
Locations: Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Specialty, West National Medical Center, Mexican Social Security Institute., Guadalajara, Jalisco, 44380, Mexico

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 Mass Index (BMI) greater than or equal to 30 kg/m2.

In Mexico, according to data from the National Health and Nutrition Survey (ENSANUT) 2018-2019, the prevalence of overweight in adults is 39.1% (36.6% in women, 42.5% in men), of obesity is 36.1% (40.2% in women, 30.5% in men) and of abdominal adiposity 81.6% (88.4% in women and 72.1% in men), with a higher proportion found in the north of the country.

In 2010, it was estimated that obesity was the main cause of 3.4 million deaths, the main complications being cardiovascular disease, diabetes mellitus and various types of cancer.

The complications of obesity are very varied, mainly presenting changes in the metabolic profile, such as increased blood pressure and abdominal circumference, hypertriglyceridemia and hypercholesterolemia. Another of the main complications derived from obesity is insulin resistance, which is defined as a decreased biological response of peripheral tissues to a specific concentration of insulin with consequent compensatory hyperinsulinemia.

The treatment of obesity is based on lifestyle changes (diet and exercise), in addition, there are pharmacological and surgical treatments, however, they are not applicable to the entire population, so despite being a highly prevalent disease with major complications, current therapeutic options are insufficient.

Triticum aestivum, better known as wheat grass, is a very common fiber in the diet of the world population, including the Mexican population, in which multiple pre-clinical studies have been reported where the effect of triticum aestivum on the decrease of components of the metabolic profile, such as glycemia, cholesterol, triglycerides and weight, as well as an improvement in insulin sensitivity, has been evidenced; To date, no serious adverse effects related to its consumption have been described, and it can be considered as an effective therapeutic alternative for patients with obesity.

Primary Outcome Measures: 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 Outcome Measures: 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