Metabolic syndrome. E88.81
Conditions
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 50 Years
Inclusion criteria
Inclusion criteria: Age between 30 and 50 years old Body mass index (BMI) ranged from 25 to 35 kg/m2 The presence of at least three of the five components of the metabolic syndrome according to the ATP III criteria including waist circumference greater than 102 cm in men and 88 cm in women, triglyceride equal to or greater than 150 mg/dL, HDL less than or equal to 40 in men and less than or equal to 50 In women, blood pressure equal to or greater than 130/85 mmHg and blood sugar equal to or greater than 100 mg/dL Willingness to participate in the study
Exclusion criteria
Exclusion criteria: Participate in weight loss programs over the past six months Weight change of more than 10% in the last six months Professional athletes or changes in the intensity and level of physical activity during the last four weeks Pregnant, lactating and postmenopausal women Allergy to dairy products and probiotics Smoking and alcohol consumption Routine consumption of products containing probiotics or synbiotics Diagnosed cardiovascular, kidney, gastrointestinal, endocrine, pulmonary, neurological, and autoimmune diseases; diabetes; thyroid dysfunction; cancer; and eating disorders. Taking medications that could affect appetite, body weight, and lipid metabolism or have anti-inflammatory effects such as corticosteroids, oral contraceptives, antidepressants and antipsychotics, anti-diabetics, statins, and other lipid-lowering drugs. Take antibiotics one month before the study begins Uncontrolled blood pressure ke probiotics and other dietary supplements within one months before the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IL-6. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: ELISA.;TNF-a. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: ELISA.;Hs-CRP. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic.;Gene expression of PPAR-?. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Real time RT-PCR.;Gene expression of LDL-R. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Real time RT-PCR.;Gene expression of NF-?B. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Real time RT-PCR. | — |
Secondary
| Measure | Time frame |
|---|---|
| Energy and macronutrients intake. Timepoint: Baseline, 6th week, and at the end of the intervention. Method of measurement: Three day dietary recall questionnaire.;Physical activity. Timepoint: Baseline, 6th week, and at the end of the intervention. Method of measurement: International Physical Activity Questionnaire.;Serum level of liver enzymes. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic.;Creatinine. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic.;Urea. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic.;Complete blood cells parameters. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Cell counter devices.;Triglycerides. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic method.;Total cholesterol (TC). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic method.;High-density lipoprotein cholesterol (HDL-C). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic method.;Low-density lipoprotein cholesterol (LDL-C). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Based on Friedwald's formula.;Fasting blood sugar. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic method.;Blood pressure. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Mercury monometer.;Body mass index. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Kg/m2.;Waist circumference. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Tape. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHossien Imani
Tehran University of Medical Sciences
Outcome results
None listed