Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512818
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2023-09-20
Brief Title:
Effect of Psiguavin for Obesity Treatment PSIGUAVIN
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Psiguavin a Bioactive Compound Derived From Psidium Guava as Therapeutic Agent for Obesity Treatment
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSIGUAVIN
Brief Summary:
The main objective of the project focuses on the study of the effectiveness of a functional component extracted from Psidium guava psiguavin as a potential inhibitor of pancreatic lipase and therefore as an adjuvant for the treatment of obesity
That is the aim is to verify from various experimental perspectives the effect of psiguavin on the activity of the enzyme pancreatic lipase EC 3113 which is the main enzyme responsible for the digestion of lipids from the diet Our preliminary studies have shown that there is a strong interaction between psiguavin and the active center of pancreatic lipase however it is necessary to confirm these initial hypotheses through a clinical trial Taking into account that the usefulness of this compound is based on the reduction of dietary calorie intake in order to confirm its therapeutic usefulness a clinical trial will be proposed
To this end the following specific objective is defined which is intended to be achieved with the execution of the project
Evaluate the effect of psiguavin on weight loss of people with overweightobese people
That is the aim is to verify from various experimental perspectives the effect of psiguavin on the activity of the enzyme pancreatic lipase EC 3113 which is the main enzyme responsible for the digestion of lipids from the diet Our preliminary studies have shown that there is a strong interaction between psiguavin and the active center of pancreatic lipase however it is necessary to confirm these initial hypotheses through a clinical trial Taking into account that the usefulness of this compound is based on the reduction of dietary calorie intake in order to confirm its therapeutic usefulness a clinical trial will be proposed
To this end the following specific objective is defined which is intended to be achieved with the execution of the project
Evaluate the effect of psiguavin on weight loss of people with overweightobese people
Detailed Description:
The latest data published by the World Health Organization WHO report that overweight and obesity are the most prevalent diseases worldwide In 2016 39 of adults worldwide were overweight and 13 were obese Although there are many factors involved in the development of obesity an excessive intake of calories especially in the form of fat and a sedentary lifestyle are still considered the key factors for the development of overweight
Currently the standard treatment or therapy for obesity is the modification of habits or lifestyles reducing energy intake through low-calorie diets and increasing energy expenditure with physical activity programs The problem is that the effectiveness of these interventions is usually very modest especially in the long term On certain occasions such as when weight losses are very small in addition to this therapy that we can define as conventional certain drugs can be prescribed to reduce caloric intake and improve the effectiveness of the dietary intervention
There are various drugs approved by the EMA and the AEMPS for the treatment of obesity on the one hand there are centrally acting agents such as the naltrexone-bupropion combination On the other hand peripherally acting agents such as liraglutide or orlistat have shown greater effectiveness for weight loss Orlistat Xenical is the best-selling obesity drug in the world and is the only drug approved for adolescents Its effectiveness is similar to other drugs but it is safer because its adverse effects are related to gastrointestinal alterations such as fecal urgency fecal incontinence flatus steatorrhea among others which are frequently the cause of abandonment of this drug treatment For all these reasons it seems evident that the most appropriate treatment for addressing obesity would be through a mechanism similar to that of orlistat and if possible with greater effectiveness and fewer adverse effects
Our previous in silico and in vitro studies have shown that the bioactive component of guava psiguavin has pharmacological characteristics very similar to orlistat which is why we considered this clinical trial to confirm in vivo these previous data
Psiguavin is a compound from the family of hydrolyzable tannins extracted from guava Psidium guajava This compound has been used in traditional botany for the treatment of disorders related to the accumulation of liver fat induced by excess sugars Despite this there are no clear bibliographic references on the compounds potential for use as a bioactive compound for application in the treatment of obesity
To this end a double-arm double-blind randomized placebo-controlled study will be carried out to analyze weight loss in overweightobese patients during a period of 3 months of treatment plus one year of follow-up
Currently the standard treatment or therapy for obesity is the modification of habits or lifestyles reducing energy intake through low-calorie diets and increasing energy expenditure with physical activity programs The problem is that the effectiveness of these interventions is usually very modest especially in the long term On certain occasions such as when weight losses are very small in addition to this therapy that we can define as conventional certain drugs can be prescribed to reduce caloric intake and improve the effectiveness of the dietary intervention
There are various drugs approved by the EMA and the AEMPS for the treatment of obesity on the one hand there are centrally acting agents such as the naltrexone-bupropion combination On the other hand peripherally acting agents such as liraglutide or orlistat have shown greater effectiveness for weight loss Orlistat Xenical is the best-selling obesity drug in the world and is the only drug approved for adolescents Its effectiveness is similar to other drugs but it is safer because its adverse effects are related to gastrointestinal alterations such as fecal urgency fecal incontinence flatus steatorrhea among others which are frequently the cause of abandonment of this drug treatment For all these reasons it seems evident that the most appropriate treatment for addressing obesity would be through a mechanism similar to that of orlistat and if possible with greater effectiveness and fewer adverse effects
Our previous in silico and in vitro studies have shown that the bioactive component of guava psiguavin has pharmacological characteristics very similar to orlistat which is why we considered this clinical trial to confirm in vivo these previous data
Psiguavin is a compound from the family of hydrolyzable tannins extracted from guava Psidium guajava This compound has been used in traditional botany for the treatment of disorders related to the accumulation of liver fat induced by excess sugars Despite this there are no clear bibliographic references on the compounds potential for use as a bioactive compound for application in the treatment of obesity
To this end a double-arm double-blind randomized placebo-controlled study will be carried out to analyze weight loss in overweightobese patients during a period of 3 months of treatment plus one year of follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None