The effect of whey protein, calcium, and vitamin D-fortified synbiotic yogurt in overweight and obese patients with metabolic syndrome

Not Applicable

• Conditions: Condition 1: Obesity. Condition 2: Metabolic syndrome.; Obesity; Other metabolic disorders

• Registration Number: IRCT2017050633836N1
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Homeostasis model assessment of insulin resistance (HOMA-IR). Timepoint: Pre and 10 weeks after intervention. Method of measurement: Equation.