Effect of soy flour enriched bread on cardiovascular diseases
Phase 2
- Conditions
- Obesity.Obesity due to excess calories
- Registration Number
- IRCT2013073114237N1
- Lead Sponsor
- Vice Chancellor for Research, Isfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria
Inclusion criteria were; female at age range of 19-35 years old; body mass index (BMI) between 25 and 35; no history of any chronic or acute diseases including; diabetes, CVD, hepatic diseases, renal diseases, cancer; not adherence to a specific diet or other medically prescribed diet no lactation and no pregnancy; no consumption of drugs and dietary supplements. Exclusion criteria: not adherence to the study protocol; use of specific drugs or supplementation; smoking; incidence of chronic diseases such as cardiovascular diseases and allergy to soya.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method High Density Lipoprotein. Timepoint: Week2, Week8, Week11, Week17. Method of measurement: mg/dl, Direct enzymatic method.;Low Density Lipoprotein. Timepoint: Week2, Week8, Week11, Week17. Method of measurement: mg/dl, Friedewald equation.;Serum total choolestrol levels. Timepoint: Week2, Week8, Week11, Week17. Method of measurement: mg/dl, Enzymatic method.;Serum triglyceride levels. Timepoint: Week2, Week8, Week11, Week17. Method of measurement: mg/dl, Enzymatic method.;ApoE genotype. Timepoint: Week2. Method of measurement: PCR method.
- Secondary Outcome Measures
Name Time Method Weight. Timepoint: baseline, Week2, Week8, Week11, Week17. Method of measurement: Kilogram, Scale.;Body Mass Index. Timepoint: Baseline, Week2, Week8, Week11, Week17. Method of measurement: kg/m2, Weight/Height square.;Waist circumference. Timepoint: Week 2, Week 8, Week 11,Week17. Method of measurement: meter, centimeter.;Hip circumference. Timepoint: Week 2, Week 8, Week 11, Week 17. Method of measurement: meter, centimeter.;Body composition. Timepoint: Week2, Week8, Week11, Week17. Method of measurement: Body Analyser systeme.;Systolic blood pressure. Timepoint: Week 2, Week 8, Week 11, Week 17. Method of measurement: Sphygmomanometer.;Diastolic blood pressure. Timepoint: Week 2, Week 8, Week 11, Week 17. Method of measurement: Sphygmomanometer.