ObesityBIOBESICOMNCT06513715
Activity of Bioactive Natural Compounds as Potential Agonists of GLP1R
A study testing Jubanine in people with Obesity and Overweight, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
The goal of this clinical trial is to learn if natural bioactive compound jubenine works to reduce appetite and to favour weight loss. It will also learn about the safety of natural bioactive compound jubenine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Jubanine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jan 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- BMI over 24.9
- no clinically relevant abnormalities and no relevant systemic disease history
Who cannot join
- the presence of any clinically relevant symptoms or severe disease within 4 weeks of the start of the study
- any history of hepatic dysfunction, any condition that might affect the pharmacokinetics properties of the study drug.
- diarrhoea (\>2 liquid stools per day) or constipation (3 days duration) 1 week prior to the start of the study
- history of hypersensitivity to GLP1R agonists
- evidence of hepatitis B or C, HIV positivity
- smoking (\>4 cigarettes/day)
- history of alcohol or substance abuse
- bulimia or laxative abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discovery of Bioactive Compounds as Agonists of GLP1 Receptor for Obesity Treatment
The goal of this clinical trial is to learn if natural bioactive compound jubenine works to reduce appetite and to favour weight loss. It will also learn about the safety of natural bioactive compound jubenine. The main questions it aims to answer are:
Does natural bioactive compound jubenine reduce the hunger perception or increase the satiety perception, and, consequently, reduce food intake? What medical problems do participants have when taking natural bioactive compound jubenine? Researchers will compare natural bioactive compound jubenine to a placebo (a look-alike substance that contains no drug) to see if natural bioactive compound jubenine works to reduce food intake for obesity treatment.
Read more
Participants will:
Take natural bioactive compound jubenine or a placebo three times every day for 3 months.
Visit the clinic once every 1 week for checkups and tests. Keep a diary of their symptoms and potenital adverse effects.
Read the detailed description
The general objective of the present project is to confirm the activity of non-peptide compounds from bioactive natural sources, concretely jubenine, which will be a GLP1R agonists for their potential therapeutic usefulness for the treatment of obesity.
The objective of the present trial was the determination of the effectiveness for weight loss, through a preclinical trial, of those compounds with the greatest potential, which according to our previous data, is jubenin.
The design of the present study is a double-blind, randomized, placebo-controlled, crossover pilot trial conducted on healthy men and women volunteers. Individuals will be randomized to receive placebo, one of a range of jubenine doses, and a nopal extract for 7 days, where participants will be maintained on a precisely controlled diet along the different interventions. Each subject will receive three standardized meals daily with 30% of calories from fat. On the intervention days, meals will be distributed at breakfast, lunch and dinner, along with one of the indicated doses according to their randomization. Meals were distributed at 08:30, 13:30 and 20:00, trying to adjust to the patients\' habits. A nurse will be present during the distribution of meals to ensure the intake of the compound.
All treatments will be delivered on green capsules, size 0, made with hard gelatin (head and body) (provided by Guinama Ltd, Valencia, Spain). These capsules are capable of disintegrating in less than 15 minutes and meet the requirements of the European Pharmacopoeia and USP. Capsucel (microcrystalline cellulose, Guinama Ltd, Valencia, Spain), will be employed as excipient in all treatments. Jubenine will be extracted from prickly pears following standard chemistry procedures. Jubenine, a prickly pear extract, with a 50% of jubanine content, will be obtained from Metapharmaceuticals (Metapharmaceuticals Ltd, Barcelona, Spain). The treatments will be made by two researchers, who will not be present at the time of administration. These researchers will also carry out the randomization, according to a Latin Square procedure, to ensure that all participants followed all the interventions. Randomization will be performed by a member of the research group with Excel software, with a visual basic Macro developed to this end.
Each study will comprise an initial screening visit one week prior to the start of the study, with a 1-day run-in period, 7-day treatment period and a 1-day post-treatment follow-up visit. The initial evaluation will be carried out by a physician, where a complete physical examination will be performed. This will allow us to exclude the presence of any disease or disorder in the participants, so all volunteers took part in the study.
The main endpoint of the effectiveness of the study will be changes in hunger/satiety sensations, determined by a visual analogic scale. Secondary endpoints will be clinical signs, and tolerability (gastrointestinal adverse effects), and clinical laboratory parameters, in particular, cholesterol, high-density lipoprotein (HDL-C), low-density lipoprotein (LDL-C), and triglycerides.
- Conditions
- Obesity, Overweight
- Being tested
- Control, Jubanine
- Keywords
- weight loss, prickly pear, obesity, overweight, appetite, hunger, satiety
- 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.
ControlDietary supplement
This intervention will be made with a placebo
JubanineDietary supplement
This intervention will be made with jubanine or prickly pear extract
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Placebo comparator | The participants allocated in this arm will follow a treatment with placebo Receives: Dietary Supplement: Control |
| Intervention 1 | Experimental | The participants in this arm will receive a 150 mg dose of jubenine Receives: Dietary Supplement: Jubanine |
| Intervention 2 | Experimental | The participants in this arm will receive a 300 mg dose of jubenine Receives: Dietary Supplement: Jubanine |
| Intervention 3 | Experimental | The participants in this arm will receive a 300 mg dose of prickly pear extract Receives: Dietary Supplement: Jubanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Percentage of weight loss from baseline weight
Measured: First evaluation will be made after 3 months of treatment, and a second evaluation will be made 12 months later.
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 start9 Jan 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion1 Jul 2026 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, 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
- Investigators
- Juan José Hernández Morante, PhD, Principal investigator, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513715
- Sponsor's protocol ID
- BIOBESICOM
- Acronym
- BIOBESICOM
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
- Discovery of Bioactive Compounds as Agonists of GLP1 Receptor for Obesity Treatment
- ClinicalTrials.gov ID
- NCT06513715
- Acronym / sponsor ID
- BIOBESICOM / BIOBESICOM
- Conditions
- Obesity, Overweight
- Keywords
- weight loss, prickly pear, obesity, overweight, appetite, hunger, satiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 1 Jul 2026 (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 goal of this clinical trial is to learn if natural bioactive compound jubenine works to reduce appetite and to favour weight loss. It will also learn about the safety of natural bioactive compound jubenine. The main questions it aims to answer are:
Does natural bioactive compound jubenine reduce the hunger perception or increase the satiety perception, and, consequently, reduce food intake? What medical problems do participants have when taking natural bioactive compound jubenine? Researchers will compare natural bioactive compound jubenine to a placebo (a look-alike substance that contains no drug) to see if natural bioactive compound jubenine works to reduce food intake for obesity treatment.
Participants will:
Take natural bioactive compound jubenine or a placebo three times every day for 3 months.
Visit the clinic once every 1 week for checkups and tests. Keep a diary of their symptoms and potenital adverse effects.
Detailed description
The general objective of the present project is to confirm the activity of non-peptide compounds from bioactive natural sources, concretely jubenine, which will be a GLP1R agonists for their potential therapeutic usefulness for the treatment of obesity.
The objective of the present trial was the determination of the effectiveness for weight loss, through a preclinical trial, of those compounds with the greatest potential, which according to our previous data, is jubenin.
The design of the present study is a double-blind, randomized, placebo-controlled, crossover pilot trial conducted on healthy men and women volunteers. Individuals will be randomized to receive placebo, one of a range of jubenine doses, and a nopal extract for 7 days, where participants will be maintained on a precisely controlled diet along the different interventions. Each subject will receive three standardized meals daily with 30% of calories from fat. On the intervention days, meals will be distributed at breakfast, lunch and dinner, along with one of the indicated doses according to their randomization. Meals were distributed at 08:30, 13:30 and 20:00, trying to adjust to the patients\' habits. A nurse will be present during the distribution of meals to ensure the intake of the compound.
All treatments will be delivered on green capsules, size 0, made with hard gelatin (head and body) (provided by Guinama Ltd, Valencia, Spain). These capsules are capable of disintegrating in less than 15 minutes and meet the requirements of the European Pharmacopoeia and USP. Capsucel (microcrystalline cellulose, Guinama Ltd, Valencia, Spain), will be employed as excipient in all treatments. Jubenine will be extracted from prickly pears following standard chemistry procedures. Jubenine, a prickly pear extract, with a 50% of jubanine content, will be obtained from Metapharmaceuticals (Metapharmaceuticals Ltd, Barcelona, Spain). The treatments will be made by two researchers, who will not be present at the time of administration. These researchers will also carry out the randomization, according to a Latin Square procedure, to ensure that all participants followed all the interventions. Randomization will be performed by a member of the research group with Excel software, with a visual basic Macro developed to this end.
Each study will comprise an initial screening visit one week prior to the start of the study, with a 1-day run-in period, 7-day treatment period and a 1-day post-treatment follow-up visit. The initial evaluation will be carried out by a physician, where a complete physical examination will be performed. This will allow us to exclude the presence of any disease or disorder in the participants, so all volunteers took part in the study.
The main endpoint of the effectiveness of the study will be changes in hunger/satiety sensations, determined by a visual analogic scale. Secondary endpoints will be clinical signs, and tolerability (gastrointestinal adverse effects), and clinical laboratory parameters, in particular, cholesterol, high-density lipoprotein (HDL-C), low-density lipoprotein (LDL-C), and triglycerides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Placebo comparator | Dietary Supplement: ControlThe participants allocated in this arm will follow a treatment with placebo |
| Intervention 1 | Experimental | Dietary Supplement: JubanineThe participants in this arm will receive a 150 mg dose of jubenine |
| Intervention 2 | Experimental | Dietary Supplement: JubanineThe participants in this arm will receive a 300 mg dose of jubenine |
| Intervention 3 | Experimental | Dietary Supplement: JubanineThe participants in this arm will receive a 300 mg dose of prickly pear extract |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI over 24.9
- no clinically relevant abnormalities and no relevant systemic disease history
Key exclusion criteria (8 listed)
- the presence of any clinically relevant symptoms or severe disease within 4 weeks of the start of the study
- any history of hepatic dysfunction, any condition that might affect the pharmacokinetics properties of the study drug.
- diarrhoea (\>2 liquid stools per day) or constipation (3 days duration) 1 week prior to the start of the study
- history of hypersensitivity to GLP1R agonists
- evidence of hepatitis B or C, HIV positivity
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 |
|---|---|---|
| ControlThis intervention will be made with a placebo | Dietary supplement | CONTROL |
| JubanineThis intervention will be made with jubanine or prickly pear extract | Dietary supplement | Intervention 1, Intervention 2, Intervention 3 |
Primary outcome
Weight loss
Time frame: First evaluation will be made after 3 months of treatment, and a second evaluation will be made 12 months later.
Percentage of weight loss from baseline weight
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Juan José Hernández Morante, PhD principal investigator
Universidad Católica San Antonio de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jubanine in people with Obesity and Overweight, 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 2 inclusion and 8 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: status not confirmed, 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.
Are results available for this study?
Results are not available in the source record.
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?
Weight loss (time frame: First evaluation will be made after 3 months of treatment, and a second evaluation will be made 12 months later.). 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.