Clinical trial

Effect of Psiguavin for Obesity Treatment (PSIGUAVIN)

Invitation only · Phase 1, Phase 2 · 1 countries · Registry ID NCT06512818

Invitation onlyPhase 1, Phase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Overweight or Obesity

Full registry criteria

Inclusion Criteria: * Being between 18 and 65 years old * Having a BMI between 25 and 40 * Voluntarily taking part in the study Exclusion Criteria: * 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

Treatments and study arms

Psiguavin

Dietary Supplement

A purified guava extract will be used, enriched in psiguavin

Placebo

Drug

Capsules with the same characteristics that Psiguavin intervention but filled with a placebo compound

Primary outcomes

Percentage of body weight lossAt 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 lossAt 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Faculty of Nursing. Catholic University of Murcia🇪🇸 Murcia, Spain

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