Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501248
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-03-26
Brief Title:
Effect of Triticum Aestivum vs Placebo on Metabolic Profile Components and Insulin Sensitivity in Patients With Obesity
Sponsor:
Coordinación de Investigación en Salud Mexico
Organization:
Coordinación de Investigación en Salud Mexico
Study Overview
Official Title:
Effect of Triticum Aestivum vs Placebo on Metabolic Profile Components and Insulin Sensitivity in Patients With Obesity
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Mass Index BMI greater than or equal to 30 kgm2
In Mexico according to data from the National Health and Nutrition Survey ENSANUT 2018-2019 the prevalence of overweight in adults is 391 366 in women 425 in men of obesity is 361 402 in women 305 in men and of abdominal adiposity 816 884 in women and 721 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 34 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
In Mexico according to data from the National Health and Nutrition Survey ENSANUT 2018-2019 the prevalence of overweight in adults is 391 366 in women 425 in men of obesity is 361 402 in women 305 in men and of abdominal adiposity 816 884 in women and 721 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 34 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None