ObesityObesity-BerberNCT06703086
Gene Modulation of NLRP3, IL-1β and TNF-α in Peripheral Blood of Patients With Exogenous Obesity Treated With Berberine
A study testing Berberine Hydrochloride group and nutritional plan in people with Obesity and Overweight, run by National Polytechnic Institute, Mexico.
Trial summary
The patients will be invited to participate in a research study aimed at determining the Gene Modulation of NLRP3, IL-1β and TNFα in peripheral blood of patients with exogenous obesity treated with berberine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Berberine
- What is being tested?
- Berberine Hydrochloride group and nutritional plan
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2019to 15 Feb 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Patients with BMI ≥ 30kg/m2
- With risk factors for type 2 diabetes (history of diabetic parents or siblings, sedentary habits)
- Fasting blood glucose ≤ 126 mg/dL or glycosylated hemoglobin < 6.5%
- Controlled arterial hypertension
- >18 years of age
- Accept and sign the informed consent
Who cannot join
- • Pregnancy patients
- Diabetics patients
- Presenting any serious adverse effect
- Patients who decide to withdraw from the protocol
About this study
The patients will be invited to participate in a research study aimed at determining the Gene Modulation of NLRP3, IL-1β and TNFα in peripheral blood of patients with exogenous obesity treated with berberine.
Read the detailed description
The study will take 6 months in total, in this study will participate patients with exogenous obesity, which is defined as an abnormal accumulation of fat that can be detrimental to health. After the evaluation it will be determined if you meet the section criteria to be able to participate in the study. The patients will be randomly assigned to a group which may be:
Group I. The investigator will give a nutritional plan according to your caloric requirements for lifestyle change and the patients will be scheduled biweekly for 3 months to assess your weight, height, body mass index and percentages of fat or muscle.
Group 2. The investigator will be given a nutritional plan and controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week.
The patient will be given a lifestyle change plan in accordance with their nutritional requirements.
Group 3. The investigator will give a nutritional plan, moderate aerobic exercise with a goal of 10,000 steps or 150 min per week; and the phytopharmaceutical Berberine will take 3 tablets every 8 hours for 3 months.
Biweekly sessions will be carried out for 3 months, then monthly for 6 months; blood samples will be taken at the beginning of the study, that is, after the informed consent, at 3 and 6 months.
- Conditions
- Obesity, Overweight, Berberine
- Being tested
- Berberine Hydrochloride group, nutritional plan, controlled moderate aerobic exercise
- Keywords
- Obesity, Overweight, Berberine
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berberine Hydrochloride groupDietary supplement
The patient will be given a nutritional plan, moderate aerobic exercise with a goal of 10,000 steps or 150 min per week; and the phytopharmaceutical Berberine will be taken 3 tablets ( 500 mg) every 8 hours for 3 months.
nutritional planBehavioural
nutritional plan according to your caloric requirements for lifestyle change and you will be scheduled biweekly for 3 months
controlled moderate aerobic exerciseBehavioural
controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional plan only | Active comparator | Nutritional plan according to your caloric requirements for lifestyle Receives: Behavioral: nutritional plan |
| Nutritional plan and moderate aerobic exercise | Active comparator | nutritional plan and controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week Receives: Behavioral: nutritional plan; Behavioral: controlled moderate aerobic exercise |
| Berberine, nutritional plan and moderate exercise | Experimental | nutritional plan, moderate aerobic exercise and the phytopharmaceutical Berberine 500 mg every 8 hours for 3 months. Receives: Dietary Supplement: Berberine Hydrochloride group; Behavioral: nutritional plan; Behavioral: controlled moderate aerobic exercise |
| No intervention | No intervention | patients who met the inclusion criteria but did not receive treatment or intervention, only somatometry and blood samples were taken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effects of Berberine on the gene modulation of NLRP3, in peripheral blood of patients with exogenous obesity
Extraction of total RNA by TRIzol®Reagent and Real-time polymerase chain reaction, qRT-PCR
Measured: From enrollment to the end of treatment at 3 months
To determine the effects of Berberine on the gene modulation of IL-1β in peripheral blood of patients with exogenous obesity
Extraction of total RNA by TRIzol®Reagent and Real-time polymerase chain reaction, qRT-PCR
Measured: "From enrollment to the end of treatment at 3 months
To determine the effects of Berberine on the gene modulation of TNFα in peripheral blood of patients with exogenous obesity
Extraction of total RNA by TRIzol®Reagent and Real-time polymerase chain reaction, qRT-PCR in peripheral blood
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (5)
Weight
The weight will be taken on a scale calibrated in kilograms.
Measured: the first 3 months every 2 weeks, then every month thereafter until 6 months are completed
Body mass index
The body mass index was calculated by dividing the weight in kilograms by the square of the height in meters.
Measured: Body mass index will be taken every two weeks for 3 months and then every month for 3 months to complete 6 months.
Percentage of body fat
Instrument: Body composition analyzer (InBody770).
- The measurement was expressed in Kg, with a precision of 0.1 kg. It was determined with the body analyzer, programmed with the required parameters (age, sex, height, among others).
Measured: It will be taken every two weeks for 3 months and then every month for 3 months to complete 6 months.
Percentage of visceral fat
- Instrument: Body composition analyzer (InBody770).
- The measurement was expressed in Kg, with a precision of 0.1 kg. It was determined with the body analyzer, programmed with the required parameters (age, sex, height, among others).
Measured: To be taken every two weeks for the first 3 months and then every month for three months to complete 6 months of follow-up.
Height
It was defined as the distance between the vertex and the support plane.
- Instrument: Stadiometer (Seca mod. 208).
- The measurement was expressed in cm with a precision of 1 mm.
Measured: Height will be measured every two weeks for 3 months and then every month for 3 months to complete the 6 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start5 Jan 2019
- Primary completion15 Aug 2019
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- Model description
- Phase three clinical trial with three intervention groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Polytechnic Institute, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Modesto Gómez López, National Polytechnic Institute, Mexico
- Investigators
- Nadia-Mabel PV PhD Nadia Mabel Pérez Vielma, PhD, Study director, 044-5520583053
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703086
- Sponsor's protocol ID
- No.ESM.CE-01/7-12-2015
- Acronym
- Obesity-Berber
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chuang TY, Wu HL, Min J, Diamond M, Azziz R, Chen YH. Berberine regulates the protein expression of multiple tumorigenesis-related genes in hepatocellular carcinoma cell lines. Cancer Cell Int. 2017 May 30;17:59. doi: 10.1186/s12935-017-0429-3. eCollection 2017.
PubMed 28572744Wei W, Zhao H, Wang A, Sui M, Liang K, Deng H, Ma Y, Zhang Y, Zhang H, Guan Y. A clinical study on the short-term effect of berberine in comparison to metformin on the metabolic characteristics of women with polycystic ovary syndrome. Eur J Endocrinol. 2012 Jan;166(1):99-105. doi: 10.1530/EJE-11-0616. Epub 2011 Oct 21.
PubMed 22019891Ali AT, Hochfeld WE, Myburgh R, Pepper MS. Adipocyte and adipogenesis. Eur J Cell Biol. 2013 Jun-Jul;92(6-7):229-36. doi: 10.1016/j.ejcb.2013.06.001. Epub 2013 Jun 14.
PubMed 23876739Sarjeant K, Stephens JM. Adipogenesis. Cold Spring Harb Perspect Biol. 2012 Sep 1;4(9):a008417. doi: 10.1101/cshperspect.a008417.
PubMed 22952395Merino M, Briones L, Palma V, Herlitz K, Escudero C. Role of adenosine receptors in the adipocyte-macrophage interaction during obesity. Endocrinol Diabetes Nutr. 2017 Jun-Jul;64(6):317-327. doi: 10.1016/j.endinu.2017.03.010. Epub 2017 May 16. English, Spanish.
PubMed 28604342Fruh SM. Obesity: Risk factors, complications, and strategies for sustainable long-term weight management. J Am Assoc Nurse Pract. 2017 Oct;29(S1):S3-S14. doi: 10.1002/2327-6924.12510.
PubMed 29024553Siani A, Cappuccio FP, Barba G, Trevisan M, Farinaro E, Lacone R, Russo O, Russo P, Mancini M, Strazzullo P. The relationship of waist circumference to blood pressure: the Olivetti Heart Study. Am J Hypertens. 2002 Sep;15(9):780-6. doi: 10.1016/s0895-7061(02)02976-x.
PubMed 12219872Peralta-Romero Jde J, Gomez-Zamudio JH, Estrada-Velasco B, Karam-Araujo R, Cruz-Lopez M. [Genetics of pediatric obesity]. Rev Med Inst Mex Seguro Soc. 2014;52 Suppl 1:S78-87. Spanish.
PubMed 24866313Al-Goblan AS, Al-Alfi MA, Khan MZ. Mechanism linking diabetes mellitus and obesity. Diabetes Metab Syndr Obes. 2014 Dec 4;7:587-91. doi: 10.2147/DMSO.S67400. eCollection 2014.
PubMed 25506234Heilbronn LK, Campbell LV. Adipose tissue macrophages, low grade inflammation and insulin resistance in human obesity. Curr Pharm Des. 2008;14(12):1225-30. doi: 10.2174/138161208784246153.
PubMed 18473870
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Modulation of NLRP3, IL-1β and TNF-α in Peripheral Blood of Patients With Exogenous Obesity Treated With Berberine
- ClinicalTrials.gov ID
- NCT06703086
- Acronym / sponsor ID
- Obesity-Berber / No.ESM.CE-01/7-12-2015
- Conditions
- Obesity, Overweight, Berberine
- Keywords
- Obesity, Overweight, Berberine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Polytechnic Institute, MexicoUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 25 Nov 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 patients will be invited to participate in a research study aimed at determining the Gene Modulation of NLRP3, IL-1β and TNFα in peripheral blood of patients with exogenous obesity treated with berberine.
Detailed description
The study will take 6 months in total, in this study will participate patients with exogenous obesity, which is defined as an abnormal accumulation of fat that can be detrimental to health. After the evaluation it will be determined if you meet the section criteria to be able to participate in the study. The patients will be randomly assigned to a group which may be:
Group I. The investigator will give a nutritional plan according to your caloric requirements for lifestyle change and the patients will be scheduled biweekly for 3 months to assess your weight, height, body mass index and percentages of fat or muscle.
Group 2. The investigator will be given a nutritional plan and controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week.
The patient will be given a lifestyle change plan in accordance with their nutritional requirements.
Group 3. The investigator will give a nutritional plan, moderate aerobic exercise with a goal of 10,000 steps or 150 min per week; and the phytopharmaceutical Berberine will take 3 tablets every 8 hours for 3 months.
Biweekly sessions will be carried out for 3 months, then monthly for 6 months; blood samples will be taken at the beginning of the study, that is, after the informed consent, at 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Phase three clinical trial with three intervention groups
| Arm | Type | Receives |
|---|---|---|
| Nutritional plan only | Active comparator | Behavioral: nutritional planNutritional plan according to your caloric requirements for lifestyle |
| Nutritional plan and moderate aerobic exercise | Active comparator | Behavioral: nutritional plan, Behavioral: controlled moderate aerobic exercisenutritional plan and controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week |
| Berberine, nutritional plan and moderate exercise | Experimental | Dietary Supplement: Berberine Hydrochloride group, Behavioral: nutritional plan, Behavioral: controlled moderate aerobic exercisenutritional plan, moderate aerobic exercise and the phytopharmaceutical Berberine 500 mg every 8 hours for 3 months. |
| No intervention | No intervention | –patients who met the inclusion criteria but did not receive treatment or intervention, only somatometry and blood samples were taken. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Patients with BMI ≥ 30kg/m2
Key exclusion criteria (4 listed)
- • Pregnancy patients
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 |
|---|---|---|
| Berberine Hydrochloride groupThe patient will be given a nutritional plan, moderate aerobic exercise with a goal of 10,000 steps or 150 min per week; and the phytopharmaceutical Berberine will be taken 3 tablets ( 500 mg) every 8 hours for 3 months. | Dietary supplement | Berberine, nutritional plan and moderate exercise |
| nutritional plannutritional plan according to your caloric requirements for lifestyle change and you will be scheduled biweekly for 3 months | Behavioural | Berberine, nutritional plan and moderate exercise, Nutritional plan and moderate aerobic exercise, Nutritional plan only |
| controlled moderate aerobic exercisecontrolled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week. | Behavioural | Berberine, nutritional plan and moderate exercise, Nutritional plan and moderate aerobic exercise |
Primary outcome
To determine the effects of Berberine on the gene modulation of NLRP3, in peripheral blood of patients with exogenous obesity
Time frame: From enrollment to the end of treatment at 3 months
Extraction of total RNA by TRIzol®Reagent and Real-time polymerase chain reaction, qRT-PCR
To determine the effects of Berberine on the gene modulation of IL-1β in peripheral blood of patients with exogenous obesity
Time frame: "From enrollment to the end of treatment at 3 months
Extraction of total RNA by TRIzol®Reagent and Real-time polymerase chain reaction, qRT-PCR
To determine the effects of Berberine on the gene modulation of TNFα in peripheral blood of patients with exogenous obesity
Time frame: From enrollment to the end of treatment at 3 months
Extraction of total RNA by TRIzol®Reagent and Real-time polymerase chain reaction, qRT-PCR in peripheral blood
5 secondary outcomes
Weight
Time frame: the first 3 months every 2 weeks, then every month thereafter until 6 months are completed
Body mass index
Time frame: Body mass index will be taken every two weeks for 3 months and then every month for 3 months to complete 6 months.
Percentage of body fat
Time frame: It will be taken every two weeks for 3 months and then every month for 3 months to complete 6 months.
Percentage of visceral fat
Time frame: To be taken every two weeks for the first 3 months and then every month for three months to complete 6 months of follow-up.
Height
Time frame: Height will be measured every two weeks for 3 months and then every month for 3 months to complete the 6 months follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Results publication: PubMed 28572744Chuang TY, Wu HL, Min J, Diamond M, Azziz R, Chen YH. Berberine regulates the protein expression of multiple tumorigenesis-related genes in hepatocellular carcinoma cell lines. Cancer Cell Int. 2017 May 30;17:59. doi: 10.1186/s12935-017-0429-3. eCollection 2017.
- Results publication: PubMed 22019891Wei W, Zhao H, Wang A, Sui M, Liang K, Deng H, Ma Y, Zhang Y, Zhang H, Guan Y. A clinical study on the short-term effect of berberine in comparison to metformin on the metabolic characteristics of women with polycystic ovary syndrome. Eur J Endocrinol. 2012 Jan;166(1):99-105. doi: 10.1530/EJE-11-0616. Epub 2011 Oct 21.
- Results publication: PubMed 23876739Ali AT, Hochfeld WE, Myburgh R, Pepper MS. Adipocyte and adipogenesis. Eur J Cell Biol. 2013 Jun-Jul;92(6-7):229-36. doi: 10.1016/j.ejcb.2013.06.001. Epub 2013 Jun 14.
- Results publication: PubMed 22952395Sarjeant K, Stephens JM. Adipogenesis. Cold Spring Harb Perspect Biol. 2012 Sep 1;4(9):a008417. doi: 10.1101/cshperspect.a008417.
- Results publication: PubMed 28604342Merino M, Briones L, Palma V, Herlitz K, Escudero C. Role of adenosine receptors in the adipocyte-macrophage interaction during obesity. Endocrinol Diabetes Nutr. 2017 Jun-Jul;64(6):317-327. doi: 10.1016/j.endinu.2017.03.010. Epub 2017 May 16. English, Spanish.
- Results publication: PubMed 29024553Fruh SM. Obesity: Risk factors, complications, and strategies for sustainable long-term weight management. J Am Assoc Nurse Pract. 2017 Oct;29(S1):S3-S14. doi: 10.1002/2327-6924.12510.
- Results publication: PubMed 12219872Siani A, Cappuccio FP, Barba G, Trevisan M, Farinaro E, Lacone R, Russo O, Russo P, Mancini M, Strazzullo P. The relationship of waist circumference to blood pressure: the Olivetti Heart Study. Am J Hypertens. 2002 Sep;15(9):780-6. doi: 10.1016/s0895-7061(02)02976-x.
- Results publication: PubMed 24866313Peralta-Romero Jde J, Gomez-Zamudio JH, Estrada-Velasco B, Karam-Araujo R, Cruz-Lopez M. [Genetics of pediatric obesity]. Rev Med Inst Mex Seguro Soc. 2014;52 Suppl 1:S78-87. Spanish.
- Results publication: PubMed 25506234Al-Goblan AS, Al-Alfi MA, Khan MZ. Mechanism linking diabetes mellitus and obesity. Diabetes Metab Syndr Obes. 2014 Dec 4;7:587-91. doi: 10.2147/DMSO.S67400. eCollection 2014.
- Results publication: PubMed 18473870Heilbronn LK, Campbell LV. Adipose tissue macrophages, low grade inflammation and insulin resistance in human obesity. Curr Pharm Des. 2008;14(12):1225-30. doi: 10.2174/138161208784246153.
- 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. This study is not recruiting at the moment.
Nadia-Mabel PV PhD Nadia Mabel Pérez Vielma, PhD study director
044-5520583053
Questions about this trial
What is this clinical trial studying?
A study testing Berberine Hydrochloride group and nutritional plan in people with Obesity and Overweight, run by National Polytechnic Institute, Mexico.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the effects of Berberine on the gene modulation of NLRP3, in peripheral blood of patients with exogenous obesity (time frame: From enrollment to the end of treatment at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06703086, which also lists 10 linked publications.
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 25 Nov 2024.