NCT06703086

Gene Modulation of NLRP3, IL-1β and TNF-α in Peripheral Blood of Patients With Exogenous Obesity Treated With Berberine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: National Polytechnic Institute, Mexico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Berberine Hydrochloride group	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.
BEHAVIORAL	nutritional plan	nutritional plan according to your caloric requirements for lifestyle change and you will be scheduled biweekly for 3 months
BEHAVIORAL	controlled moderate aerobic exercise	controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week.

Timeline

• Start date: 2019-01-05
• Primary completion: 2019-08-15
• Completion: 2020-02-15
• First posted: 2024-11-25
• Last updated: 2024-11-25