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

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.

Conditions

• Obesity
• Drug Effect
• Insulin Sensitivity

Interventions

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.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico

  lead OTHER_GOV

Principal Investigators

• Sandra O Hernández González, PhD · Instituto Mexicano del Seguro Social, Unidad de Investigación Biomédica 02

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-14

Primary Completion

2024-08-30

Completion

2024-12-10

Countries

• Mexico

Study Locations