Condition 1: Metabolic Syndrome. Condition 2: Metabolic Syndrome. Condition 3: Metabolic Syndrome. Atherosclerotic heart disease Non-insulin-dependent diabetes mellitus Hypertensive heart disease
Conditions
Interventions
Intervention 1: Soy protein, 35 grams, once per day for three months, (?Soy protein will be delivered to individuals in 490 grams packages with special tool for measurement for consumption of two week
Treatment - Drugs
Soy protein, 35 grams, once per day for three months, (?Soy protein will be delivered to individuals in 490 grams packages with special tool for measurement for consumption of two weeks)
Soy-nut, 35 grams, once per day for three months, (Soy-nut will be delivered to individuals in 490 gm packages for two weeks consumption)
Sponsors
Babol University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
60 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Women, age 60-70 years, BMI between 18.5-29, having at least three criteria of diagnostic criteria of MS, diagnosis of Metabolic syndrome according to the latest update of ATP-III (1. Waist circumference = 80 cm 2. TG = 150 mg/dl 3. HDL < 50 mg/dl 4. FPG = 101 mg/dl 5, blood pressure = 130/85) Exclusion criteria: Current or previous estrogen therapy (in the preceding 6 mo), use of soy products or supplements (at least once per week for last 3 month), treatment with insulin or oral hypoglycemic, antilipemic, or hypertensive agents, treatment for Ischemic heart disease, vegetarian diet (more than six months), smoking (for 3 mo), antibiotic therapy (for last 3 month), documented hyper or hypothyroidism, presence of kidney or liver diseases, breast cancer or any other cancer, the history of CVD, in hearing or mental problem (not able to establish a communication ), or allergy to soy
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure. Timepoint: Before starting the intervention and then monthly for three month until the end of intervention. Method of measurement: Blood Pressure will be measured in Mm/Hg unit, twice at the right arm after the participants sit for 15 min, by using a standard mercury sphygmomanometer calibrated. The average of two measurements will be used for data analysis. If the first measurements differ by more than 5 mmHg, additional readings will be obtained.;Lipid profile (LDL-C, HDL-C, Total cholesterol, TG). Timepoint: Before starting the intervention and at the end of the intervention. Method of measurement: Serum concentration of lipid profil will be measured in Mg/dl unit using commercially available enzymatic reagents adapted to a Hitachi autoanalyzer.;Insulin. Timepoint: Before starting the intervention and at the end of the intervention. Method of measurement: Insulin serum concentration will be measured in µIU/ml unit by using ELISA method.;Insulin resistance. Timepoint: Insulin resistanceBefore starting the intervention and at the end of the intervention will be measured before starting the intervention and after end of the intervention (in the third month). Method of measurement: Insulin resistance will be calculated by using the homeostasis model of assessment insulin resistance (HOMA-IR) according to this formula: Glucose × Insulin/405.;Apolipoprotein B100 and apoA-I. Timepoint: Before starting the intervention and at the end of the intervention. Method of measurement: Apolipoprotein B100 and apoA-I serum concentrations will be measured in g/l unit by ELISA method. In this study will be used standard and control solutions for all measurements.;CRP. Timepoint: Before starting the intervention and at the end of the intervention. Method of measurement: CRP serum concentration will be measured in Mg/dl unit by using ELISA method by Selectra machine.;Malondialdehyde (MDA). Timepoint: Before starting the intervention and at the end of the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Food intake status. Timepoint: Before starting the intervention and then monthly for three month until the end of intervention. Method of measurement: Food intake status will be assessed by 3-d diet record questionnaire.;Physical activity. Timepoint: Before starting the intervention and then monthly for three month until the end of intervention. Method of measurement: Physical activity will be assessed by IPAQ questionnaire. This questionnaire will be completed in the forth week of every month for 7 days. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAfsaneh Bakhtiari
Babol University of Medical Sciences
Outcome results
None listed