Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513715
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Activity of Bioactive Natural Compounds as Potential Agonists of GLP1R
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Discovery of Bioactive Compounds as Agonists of GLP1 Receptor for Obesity Treatment
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOBESICOM
Brief 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 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
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 0830 1330 and 2000 trying to adjust to the patients39 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 hungersatiety 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
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 0830 1330 and 2000 trying to adjust to the patients39 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 hungersatiety 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None