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临床试验/NCT06512818
NCT06512818Enrolling By Invitation1 期

Effect of Psiguavin, a Bioactive Compound Derived From Psidium Guava, as Therapeutic Agent for Obesity Treatment

Universidad Católica San Antonio de Murcia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月8日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
Enrolling By Invitation
发起方
入组人数
100
试验地点
1
主要终点
Percentage of body weight loss

研究概览

简要总结

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 3.1.1.3), 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 overweight/obese people.

详细描述

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 compound's potential for use as a bioactive compound for application in the treatment of obesity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being between 18 and 65 years old
  • Having a BMI between 25 and 40
  • Voluntarily taking part in the study

排除标准

  • Have been on a diet for at least 6 months before the start of the study.
  • Taking chronic medication that can alter metabolism (thyroid drugs, corticosteroids, etc.)
  • Having a contraindication for guava
  • Having an intestinal chronic disease
  • Being pregnant

研究组 & 干预措施

INTERVENTION WITH PSIDIUM GUAVA EXTRACT

Experimental

The volunteers in this group will undergo an intervention with a dose of 300 mg of psiguavin derived from Psidium guava extracts, three times a day, with each main meal.

干预措施: Psiguavin (Dietary Supplement)

PLACEBO CONTROLLED INTERVENTION

Placebo Comparator

The volunteers in this group will undergo a placebo (microcellulose) with similar aspect than intervention, three times a day, with each main meal.

干预措施: Placebo (Drug)

结局指标

主要结局

Percentage of body weight loss

时间窗: At three months from baseline and after one-year of follow-up

It will be calculated by subtracting the initial weight less to the final weight, divided by the initial weight and multiplied by 100.

Percentage of body fat loss

时间窗: At three months from baseline and after one-year of follow-up

Meaured by impedance, the change in final fat percentage with respect to the initial value will be calculated.

次要结局

  • Plasma triglyceride levels(At three months from baseline and after one-year of follow-up)
  • Metabolic syndrome status(At three months from baseline and after one-year of follow-up)
  • Plasma total cholesterol levels(At three months from baseline and after one-year of follow-up)
  • Fasting plasma glucose levels(At three months from baseline and after one-year of follow-up)

研究者

发起方
Universidad Católica San Antonio de Murcia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan Jose Hernández Morante

Research Coordinator of the Faculty of Nursing Studies

Universidad Católica San Antonio de Murcia

研究点 (1)

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