ObesityPhase 1/2PSIGUAVINNCT06512818
Effect of Psiguavin for Obesity Treatment (PSIGUAVIN)
A Phase 1/2 study testing Psiguavin in people with Obesity and Overweight or Obesity, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Overweight or Obesity
- What is being tested?
- Psiguavin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2025to 19 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between 18 and 65 years old
- Having a BMI between 25 and 40
- Voluntarily taking part in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Psiguavin, a Bioactive Compound Derived From Psidium Guava, as Therapeutic Agent for Obesity Treatment
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.
Read more
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.
Read the 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 compound's 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 overweight/obese patients during a period of 3 months of treatment plus one year of follow-up.
- Conditions
- Obesity, Overweight or Obesity
- Being tested
- Psiguavin, Placebo
- Keywords
- obesity, weight loss, pancreatic lipase, psiguavin
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsiguavinDietary supplement
Also called Guava extract
A purified guava extract will be used, enriched in psiguavin
PlaceboDrug
Also called Placebo controlled intervention
Capsules with the same characteristics that Psiguavin intervention but filled with a placebo compound
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Psiguavin |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At three months from baseline and after one-year of follow-up
Secondary outcomes (4)
Metabolic syndrome status
The diagnosis of metabolic syndrome will be analyzed according to the IDF criteria.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At three months from baseline and after one-year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start8 Jan 2025 (estimated)
- Primary completion19 Dec 2026 (estimated)
- Study completion19 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There wiil be two arms. One group will undergo the intervention with the bioactive compound psiguavin, and the other will follow a placebo-based treatment. Both groups will start and finish the project at the same time.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Jose Hernández Morante, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512818
- Sponsor's protocol ID
- BIO_HPC-2
- Acronym
- PSIGUAVIN
- Status last verified
- Jul 2024
- First submitted
- 20 Sep 2023
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Psiguavin, a Bioactive Compound Derived From Psidium Guava, as Therapeutic Agent for Obesity Treatment
- ClinicalTrials.gov ID
- NCT06512818
- Acronym / sponsor ID
- PSIGUAVIN / BIO_HPC-2
- Conditions
- Obesity, Overweight or Obesity
- Keywords
- obesity, weight loss, pancreatic lipase, psiguavin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 8 Jan 2025 (estimated)
- Primary completion
- 19 Dec 2026 (estimated)
- Study completion
- 19 Dec 2027 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 compound's 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 overweight/obese patients during a period of 3 months of treatment plus one year of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- There wiil be two arms. One group will undergo the intervention with the bioactive compound psiguavin, and the other will follow a placebo-based treatment. Both groups will start and finish the project at the same time.
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION WITH PSIDIUM GUAVA EXTRACT | Experimental | Dietary Supplement: PsiguavinThe 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. |
| PLACEBO CONTROLLED INTERVENTION | Placebo comparator | Drug: PlaceboThe volunteers in this group will undergo a placebo (microcellulose) with similar aspect than intervention, three times a day, with each main meal. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between 18 and 65 years old
- Having a BMI between 25 and 40
- Voluntarily taking part in the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsiguavinAlso: Guava extractA purified guava extract will be used, enriched in psiguavin | Dietary supplement | INTERVENTION WITH PSIDIUM GUAVA EXTRACT |
| PlaceboAlso: Placebo controlled interventionCapsules with the same characteristics that Psiguavin intervention but filled with a placebo compound | Drug | PLACEBO CONTROLLED INTERVENTION |
Primary outcome
Percentage of body weight loss
Time frame: 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
Time frame: 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.
4 secondary outcomes
Metabolic syndrome status
Time frame: At three months from baseline and after one-year of follow-up
Plasma total cholesterol levels
Time frame: At three months from baseline and after one-year of follow-up
Plasma triglyceride levels
Time frame: At three months from baseline and after one-year of follow-up
Fasting plasma glucose levels
Time frame: At three months from baseline and after one-year of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Psiguavin in people with Obesity and Overweight or Obesity, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of body weight loss (time frame: At three months from baseline and after one-year of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.