Essential (primary) hypertension. Insulin resistance. Hyperlipidemias. Obesity.
Conditions
Interventions
The study will last 12 weeks and participants will be randomly assigned to 2 groups to receive either capsules containing probiotics (probiotics group) or capsules containing placebo (control group).
Dietary supplement
G07.203.300.456
Sponsors
Universidade do Estado do Rio de Janeiro
Hospital Universitário Pedro Ernesto
Eligibility
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: Individuals aged 40 to 65 years. Both sexes, women in post-menopausal period. Body mass index equal or more than 30.0 and less than 40.0 kg per m². Diagnosis of hypertension on regular treatment with antihypertensive drugs for at least 4 weeks. Signature of the informed consent.
Exclusion criteria
Exclusion criteria: Individuals with evidence of secondary hypertension or presenting blood pressure equal or greater than 160 x 100 mmHg. Diabetes mellitus and or use of insulin or oral hypoglycemic agents. Diagnosis of malignant or autoimmune diseases. Chronic kidney or hepatic diseases. Clinical signs of heart failure or of changes in thyroid function. Use of probiotics, prebiotics, symbiotics, antibiotics, hypolipidemic drugs, hormone replacement therapy, proton pump inhibitors, antioxidant and/or anti-inflammatory supplements including vitamin, mineral or omega 3 in the last 3 months. Recent changes (last 3 months) in body weight (equal or greater than 3kg) and/or in food intake. Current or former smokers (last 12 months). Physical activity practitioners. Vegetarians. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a higher blood pressure reduction in the probiotics group than in the control group, using the oscillometric method, with a validated semiautomatic device, by observing a significant difference in the change in blood pressure (pre and post intervention) when comparing the two study groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find a greater reduction in body adiposity in the probiotics group than in the control group, using anthropometry, bioelectrical impedance analysis and dual energy radiological absorptiometry (DXA) as methods, by observing a significant difference in the change in body adiposity (pre and post intervention) when comparing the two study groups. ;It is expected to find a reduction in insulin resistance greater in the probiotics group than in the control group, using as methods the evaluation of serum glucose concentration (hexokinase enzymatic method) and insulin (electrochemiluminescence method) and the calculation of the resistance index (HOMA-IR), by observing a significant difference in the change in HOMA-IR (pre and post intervention) when comparing the two study groups. ;It is expected to find a reduction in serum concentration of total cholesterol (evaluated by enzymatic colorimetric method) and LDL-cholesterol (estimated by Friedewald formula) higher in the probiotics group than in the control group, by observing of a significant difference in the changes of these serum lipids (pre and post intervention) when comparing the two study groups. ;It is expected to find an increase in serum concentration of adiponectin and a reduction in serum concentration of resistin, tumor necrosis factor-a (TNF-a) and interleukin-6 (IL-6), evaluated by the Luminex method, higher in the probiotics group than in the control group, by observing of a significant difference in the changes of these serum adipokines (pre and post intervention) when comparing the two study groups. ;It is expected to find a reduction in serum concentration of C-reactive protein (CRP) using the turbidimetry method, higher in the probiotics group than in the control group, by observing of a significant difference in the changes of this inflammatory marker (pre and post intervention) when comparing the two study groups.;It is expected to find a reduction in serum concentration of | — |
Countries
Brazil
Contacts
Public ContactMárcia Klein
Universidade do Estado do Rio de Janeiro
Outcome results
None listed