Effect of Psiguavin for Obesity Treatment (PSIGUAVIN)
NCT Number: NCT06512818
Acronym: PSIGUAVIN
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Obesity|Overweight or Obesity
Interventions: DIETARY_SUPPLEMENT: Psiguavin|DRUG: Placebo
Sponsor: Universidad Católica San Antonio de Murcia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01-08
Completion Date: 2027-12-19
Locations: Faculty of Nursing. Catholic University of Murcia, Murcia, 30107, Spain

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 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.

Primary Outcome Measures: Percentage of body weight loss, It will be calculated by subtracting the initial weight less to the final weight, divided by the initial weight and multiplied by 100., At three months from baseline and after one-year of follow-up|Percentage of body fat loss, Meaured by impedance, the change in final fat percentage with respect to the initial value will be calculated., At three months from baseline and after one-year of follow-up
Secondary Outcome Measures: Metabolic syndrome status, The diagnosis of metabolic syndrome will be analyzed according to the IDF criteria., At three months from baseline and after one-year of follow-up|Plasma total cholesterol levels, Changes in total cholesterol levels will analyzed determining the plasma cholesterol at the end of the intervention minus baseline cholesterol (measured in mg/dl), At three months from baseline and after one-year of follow-up|Plasma triglyceride levels, Changes in triglyceride levels will analyzed determining the plasma triglycerides at the end of the intervention minus baseline triglycerides (measured in mg/dl), At three months from baseline and after one-year of follow-up|Fasting plasma glucose levels, Changes in fasting glucose levels will analyzed determining the plasma fasting glucose at the end of the intervention minus baseline fasting plasna (measured in mg/dl), At three months from baseline and after one-year of follow-up