NCT06501248

Effect of Triticum Aestivum vs Placebo on Metabolic Profile Components and Insulin Sensitivity in Patients With Obesity

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Coordinación de Investigación en Salud, Mexico · Other Government
• Sex: All
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

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.

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 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. A total of 36 patients will be followed, which will be distributed as follows: 1) A group of 18 patients with a diagnosis of obesity without pharmacological or emergency treatment, who will receive 500 mg of triticum aestivum orally every 12 hours for 120 days, and 2) A group of 18 patients diagnosed with obesity without pharmacological or surgical treatment, who will receive 500 mg of placebo (calcined magnesia) orally every 12 days for 120 days.

Conditions

• Obesity
• Drug Effect
• Insulin Sensitivity

Interventions

Type	Name	Description
DRUG	Triticum Aestivum	The intervention period will be 120 days, searching for effects on insulin sensitivity and metabolic control.
DRUG	Placebo (calcined magnesia)	The intervention period will be 120 days, searching for effects on insulin sensitivity and metabolic control.

Timeline

• Start date: 2022-07-14
• Primary completion: 2024-08-30
• Completion: 2024-12-10
• First posted: 2024-07-15
• Last updated: 2024-07-15

Locations

1 site across 1 country: Mexico