Effect of soy flour enriched bread on cardiovascular diseases

Effect of soy flour enriched bread consumption or regular weight loss diet on anthropometric indices, blood pressure and serum lipid profile and its association with apoE genotype in over weight/ obese women: a randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013073114237N1

Enrollment

Registered

2013-09-05

Start date

2012-09-28

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity. Obesity due to excess calories

Interventions

Intervention 1: Soy bread group: energy requirement will be calculated according to equations suggested by the Institute of Medicine, Food and Nutrition Board. for weight loss 300-500 calorie of calcu

Treatment - Other

Soy bread group: energy requirement will be calculated according to equations suggested by the Institute of Medicine, Food and Nutrition Board. for weight loss 300-500 calorie of calculated energy wil

Usual diet: energy requirement for each participant will calculated based on equations suggested by the Institute of Medicine, Food and Nutrition Board. 300-500 calorie will reduced for weight loss.

Eligibility

Sex/Gender

Female

Age

19 Years to 35 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Sharifi Zahabi

Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medica

Elham_sharifi@nutr.mui.ac.ir+98 31 1792 2752

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026