Berberine, Obesity, Overweight
Conditions
Keywords
Obesity, Overweight, Berberine
Brief 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.
Interventions
DIETARY_SUPPLEMENTBerberine 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.
BEHAVIORALnutritional plan
nutritional plan according to your caloric requirements for lifestyle change and you will be scheduled biweekly for 3 months
BEHAVIORALcontrolled moderate aerobic exercise
controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week.
Sponsors
National Polytechnic Institute, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase three clinical trial with three intervention groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the effects of Berberine on the gene modulation of NLRP3, in peripheral blood of patients with exogenous obesity | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of visceral fat | 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. | * 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). |
| Weight | the first 3 months every 2 weeks, then every month thereafter until 6 months are completed | The weight will be taken on a scale calibrated in kilograms. |
| Height | Height will be measured every two weeks for 3 months and then every month for 3 months to complete the 6 months follow-up. | 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. |
| Body mass index | Body mass index will be taken every two weeks for 3 months and then every month for 3 months to complete 6 months. | The body mass index was calculated by dividing the weight in kilograms by the square of the height in meters. |
| Percentage of body fat | It will be taken every two weeks for 3 months and then every month for 3 months to complete 6 months. | 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). |
Outcome results
None listed