IRCT138804212130N1 IRCT 2009-10-20 Babol University of Medical Sciences Soy and metabolic Syndrome The Effects of Soy-nut and Soy-protein on the Features of Metabolic Syndrome among Elderly Women in Babol, Iran 2009-07-23 anticipated 75 Complete https://irct.ir/trial/1750 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other. 2-3 Condition 1: Metabolic Syndrome. Condition 2: Metabolic Syndrome. Condition 3: Metabolic Syndrome. 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 weeks). Intervention 2: 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).

public Afsaneh Bakhtiari

Babol University of Medical Sciences

Babol Iran (Islamic Republic of) 4717647745 +98 11 1222 3841 afbakhtiari@gmail.com Babol University of Medical Sciences scientific Afsaneh Bakhtiari

Babol University of Medical Sciences

Babol Iran (Islamic Republic of) 4717647745 +98 11 1222 7667 afbakhtiari@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) 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 60 years 70 years Female I25.1 E11 I11 Atherosclerotic heart disease Non-insulin-dependent diabetes mellitus Hypertensive heart disease Treatment - Drugs 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) Weight. Timepoint: Before starting the intervention and then monthly for three month until the end of intervention. Method of measurement: Body weight will be measured in kilogram unit while the participants are minimally clothed without shoes by using digital scales and record to the nearest 100 g. Waist circumference. Timepoint: Before starting the intervention and then monthly for three month until the end of intervention. Method of measurement: Waist circumference will be measured in centimeter unit to the nearest value to 0.1 cm and at the narrowest level of waist, in the end of expiration. Hip circumference. Timepoint: Before starting the intervention and then monthly for three month until the end of intervention. Method of measurement: Hip circumference is measured in centimeter at the maximum level over light clothing, by using an unscratched tape measure, without any pressure to body surface. Body Mass Index (BMI). Timepoint: Before starting the intervention and then monthly for three month until the end of intervention. Method of measurement: BMI is calculated in kg/m2 unit as weight (in kg) divided by height (in m2). Sub scapula Skin fold (SSF). Timepoint: Before starting the intervention and then monthly for three month until the end of intervention. Method of measurement: SSF determines the amount of fat storage of sub cutaneous. SSF will be measured in centimeter in sub scapula area by Caliper tool. Every measurement will be repeated three times and the mean of them will be considered. Then SSF will be compared to standard tables . 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. Method of measurement: MDA serum concentration will be measured in nmol/l unit on basis HPLC method and using the established thiobarbituric acid (TBARS) method. Blood glucose. Timepoint: Before starting the intervention and at the end of the intervention. Method of measurement: Glucose serum concentration is measured in Mg/dl unit on the day of blood collection by an enzymatic colorimetric method by using glucose oxidase. Total antioxidant capacity (TAC). Timepoint: Before starting the intervention and at the end of the intervention. Method of measurement: TAC serum concentration will be measured in nmol/l unit by FRAP methode. 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. Babol University of Medical Sciences Approved Babol University of Medical Sciences Babol University of Medical Sciences, Ganj Afrooz Ave, Babol , Mazandaran, Iran. Babol Iran (Islamic Republic of)