Ignite Creation Date:
2024-07-17 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496100
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-03-26
Brief Title:
Effect of Triticum Aestivum on Appetite Ghrelin Leptin Adiponectin Hormonal Axis 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 on Appetite Regulation and the Ghrelin Leptin Adiponectin Hormonal Axis in Patients With Obesity
Status:
RECRUITING
Status Verified Date:
2024-03
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 represents one of the major health problems worldwide it is clear that current approaches to address obesity are largely unsuccessful The endocrine axis of leptin and ghrelin acts as the critical link between adipose tissue and hypothalamic centers that regulate food intake satiety energy expenditure and weight
Despite being a highly prevalent disease with major complications current therapeutic options are not sufficient as they are not ideal for the entire population The importance of new pharmacological interventions that can be evaluated in the population at risk as an early form of treatment to avoid the development of chronic diseases with high morbidity and mortality
Natural products such as Triticum aestivum and their high content of bioactive principles have been described for their pharmacokinetic functions in weight reduction insulin resistance and modulation of neuropeptides involved in food intake
Despite being a highly prevalent disease with major complications current therapeutic options are not sufficient as they are not ideal for the entire population The importance of new pharmacological interventions that can be evaluated in the population at risk as an early form of treatment to avoid the development of chronic diseases with high morbidity and mortality
Natural products such as Triticum aestivum and their high content of bioactive principles have been described for their pharmacokinetic functions in weight reduction insulin resistance and modulation of neuropeptides involved in food intake
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
Two parallel groups with randomization by software using envelopes will require a total of 38 patients which will be distributed as follows 1 A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment who will receive 500 mg capsules with lyophilized Triticum aestivum orally every 12 hours for 120 days and 2 A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment who will receive 500 mg capsules of placebo calcined magnesia orally every 12 hours for 120 days
Two parallel groups with randomization by software using envelopes will require a total of 38 patients which will be distributed as follows 1 A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment who will receive 500 mg capsules with lyophilized Triticum aestivum orally every 12 hours for 120 days and 2 A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment who will receive 500 mg capsules of placebo calcined magnesia orally every 12 hours 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