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IRCT2017050633836N1 IRCT 2017-07-15 Shiraz University of Medical Sciences The effect of whey protein, calcium, and vitamin D-fortified synbiotic yogurt in overweight and obese patients with metabolic syndrome Evaluating the effect of whey protein, calcium, and vitamin D-fortified synbiotic yogurt compared with low-fat conventional yogurt on anthropometric indices, insulin resistance, lipid profiles, inflammatory markers and appetite status in overweight and obese patients with metabolic syndrome following the balanced hypocaloric diet. 2016-12-15 anticipated 90 Complete https://irct.ir/trial/26007 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Condition 1: Obesity. Condition 2: Metabolic syndrome. Intervention 1: Intervention group was provided 2 servings/day of FY (2×250 ml/day) plus weight-loss diet for 10 weeks. One serving of FY contained 5 g whey protein, 3 g inulin as perbiotic, 500 mg calcium, 500 IU vitamin D and bifidobacteria as probiotic. Intervention 2: Control group was provided 2 servings/day of CY (2×250 ml/day) containing Lactobacillus bulgaricus and Streptococcus thermophile plus weight-loss diet for 10 weeks.
public Mohsen Mohammadi Sartang
Razi Avenue, School of Nutrition and Food Science, Shiraz University of Medical Sciences, Shiraz, Iran
Shiraz Iran (Islamic Republic of) +98 71 3725 1001 mohsen.nut85@yahoo.com Shiraz University of Medical sciences scientific Dr Zohreh Mazloom
Razi Avenue, School of Nutrition and Food Science, Shiraz University of Medical Sciences, Shiraz, Iran
Shiraz Iran (Islamic Republic of) +98 71 3725 1001 zohreh.mazloom@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) The inclusion criteria: aged between 20 and 60 years and a BMI of 25.0–35 kg/m2. The metabolic syndrome was diagnosed as having three of the following five features: waist circumference (≥102 cm in men and ≥88 cm in women); try glycerol levels (≥150 mg/dl); HDL-C levels (<40 mg/dl in men and <50 mg/dl in women); blood pressure (≥130/ 85mmHg or on treatment for hypertension); glucose levels (≥100 mg/dl. The ability to understand the study protocol and provide written informed consent. The exclusion criteria were as follows: an inability or unwillingness to participate; antibiotic treatment; more than 10% weight change over the preceding 6 months; recent (four weeks) changes in exercise intensity or frequency; nonconsumption of low-fat yogurts habitually; consumption of probiotic products habitually; intake of medications that could affect body weight, calcium or vitamin D metabolism; taking drugs for blood glucose or lipid control; taking multivitamin-mineral supplements, omega-3 and oral contraceptive peel; Allergy to probiotic or dairy products; smoking or alcohol consumption; serious medical illnesses including cardiovascular, gastrointestinal, cancer, neurologic, renal, hepatic, endocrine, rheumatoid, thyroid and eating disorders. We also excluded the pregnant or lactating women. We also made sure that the subjects had not participated in any other weight management studies within the last 6 months of screening. Other exclusion criteria during the study included: non-compliance to the study protocol; the occurrence of serious adverse events and any changes in intensity or frequency of exercise. 20 years 60 years Both E66 E88 Obesity Other metabolic disorders Treatment - Other Treatment - Other Intervention group was provided 2 servings/day of FY (2×250 ml/day) plus weight-loss diet for 10 weeks. One serving of FY contained 5 g whey protein, 3 g inulin as perbiotic, 500 mg calcium, 500 IU vitamin D and bifidobacteria as probiotic. Control group was provided 2 servings/day of CY (2×250 ml/day) containing Lactobacillus bulgaricus and Streptococcus thermophile plus weight-loss diet for 10 weeks. Homeostasis model assessment of insulin resistance (HOMA-IR). Timepoint: Pre and 10 weeks after intervention. Method of measurement: Equation. Anthropometric indices (weight, waist circumference, BMI). Timepoint: Pre and post intervention. Method of measurement: Pre and post intervention. Body composition measurements (Fat mass and fat free mass). Timepoint: At the beginning and at the end of the study. Method of measurement: BIA. Fasting blood glucose. Timepoint: At the beginning and at the end of the study. Method of measurement: Biochemical. Serum insulin. Timepoint: At the beginning and at the end of the study. Method of measurement: ELISA. Lipid profile (triglycerides (TG), total cholesterol (TC), low density lipoprotein (LDL) and high density lipoprotein (HDL) ). Timepoint: At the beginning and at the end of the study. Method of measurement: Enzymatic methods. Blood pressure. Timepoint: At the beginning and at the end of the study. Method of measurement: Digital Barometer. 25 (OH)vit D. Timepoint: At the beginning and at the end of the study. Method of measurement: ELISA. Serum MDA. Timepoint: At the beginning and at the end of the study. Method of measurement: TBARS method. Hs-CRP. Timepoint: At the beginning and at the end of the study. Method of measurement: ELISA. Serum adiponectin. Timepoint: At the beginning and at the end of the study. Method of measurement: ELISA. Endothelin-1. Timepoint: At the beginning and at the end of the study. Method of measurement: ELISA. Appetite status. Timepoint: At the beginning, at 5 weeks and at the end of the study. Method of measurement: by visual analog scales (VAS). Shiraz University of Medical Sciences Approved 2016-12-14 Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Shiraz, Iran Shiraz Iran (Islamic Republic of)