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

National Polytechnic Institute, Mexico

Status: Completed

Conditions: Overweight; Obesity; Berberine

Treatments: Dietary Supplement: Berberine Hydrochloride group; Behavioral: nutritional plan; Behavioral: controlled moderate aerobic exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06703086

No.ESM.CE-01/7-12-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• • 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

Exclusion criteria

• • Pregnancy patients

  • Diabetics patients
  • Presenting any serious adverse effect
  • Patients who decide to withdraw from the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Nutritional plan only

Active Comparator group

Description:

Nutritional plan according to your caloric requirements for lifestyle

Treatment:

Behavioral: nutritional plan

Nutritional plan and moderate aerobic exercise

Active Comparator group

Description:

nutritional plan and controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week

Treatment:

Behavioral: controlled moderate aerobic exercise

Behavioral: nutritional plan

Berberine, nutritional plan and moderate exercise

Experimental group

Description:

nutritional plan, moderate aerobic exercise and the phytopharmaceutical Berberine 500 mg every 8 hours for 3 months.

Treatment:

Behavioral: controlled moderate aerobic exercise

Behavioral: nutritional plan

Dietary Supplement: Berberine Hydrochloride group

No intervention

No Intervention group

Description:

patients who met the inclusion criteria but did not receive treatment or intervention, only somatometry and blood samples were taken.