Effect of soybean flour enriched bread consumption on inflammation, lipid profile, glycemic indices and Anthropometric indices

Effect of soybean flour enriched bread consumption or usual dietary recommendation on serum levels of inflammatory bio markers, lipid profile, glycemic indices and Anthropometric indices in patients with type 2 diabetes: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013061613684N1

Enrollment

Registered

2013-08-18

Start date

2012-12-07

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

diabetes. diabetes mellitus, adult-onset, nonketotic, stable, type II

Interventions

Intervention 1: soybean flour enriched bread group: soy bread will be enriched by substituting 30% of the wheat flour by soybean flour. participants in the intervention group will be asked to replace

Treatment - Other

soybean flour enriched bread group: soy bread will be enriched by substituting 30% of the wheat flour by soybean flour. participants in the intervention group will be asked to replace 120 gr of soy br

Recommendation group: information about healthy diet has been prescribed for this group. usual dietary recommendation includes healthy food choices. participants in recommendation group will be asked

Eligibility

Sex/Gender

Female

Age

30 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Diabetic non menopause; non-pregnant and non-lactating females; aged 30-50 y; body mass index greater than 25; Lack of insulin injection; non-smokers; lack of allergy to soyabean; lack of having a special diet; lack of sever weight loss in the last 3 months; lack of hormone therapy; not having sever infection in the last 3 months; trauma; surgery; hypo- and hyper-thyroidism; vitamin and mineral supplements; and corticosteroids. Exclusion criteria: affecting by the above-mentioned diseases or starting the use of above-mentioned medications; alterations in dosage and type of current medications; getting pregnant; allergy to soyabean; the use of medications and supplements such as multivitamin mineral supplementation; omega-3 fatty acids; smoking

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Serum high sensitive-C Reactive Protein (hs-CRP) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: high sensitive immunoturbidimetry, mg/dL.;Serum Inter-Cellular Adhesion Molecule 1 (sICAM-1) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ?µg/L.;Serum vascular cell adhesion molecule 1 (sVCAM-1) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ?µg/L.;Serum high sensitive tumor necrosis factor-alpha (hs TNF-a) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ?mg/dL.;Serum high sensitive Interleukin 6 (hs IL-6) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ?ng/dL.	—

Measure

Time frame

Serum high sensitive-C Reactive Protein (hs-CRP) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: high sensitive immunoturbidimetry, mg/dL.;Serum Inter-Cellular Adhesion Molecule 1 (sICAM-1) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ?µg/L.;Serum vascular cell adhesion molecule 1 (sVCAM-1) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ?µg/L.;Serum high sensitive tumor necrosis factor-alpha (hs TNF-a) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ?mg/dL.;Serum high sensitive Interleukin 6 (hs IL-6) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ?ng/dL.

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Secondary

Measure	Time frame
Glycated hemoglobin(HbA1C). Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Ion exchange chromatography.;Weight. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: scale, kilogram.;Waist circumference. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: meter, centimeter.;Body mass index. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: kg/m2, Weight/Height square.;Diastolic blood pressure. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: mmHg, Mercurial sphygmomanometer.;Systolic blood pressure. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: mmHg, Mercurial sphygmomanometer.;Fasting blood sugar. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: mg/dL, Colorimetric.;Serum Triglyceride levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: photometrics, mg/dL.;Serum total cholesterol levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: photometrics, mg/dL.;Serum Low-Density Lipoprotein cholesterol (LDL-c) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzymatic, mg/dL.;Serum High-Density Lipoprotein cholesterol (HDL-c) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: photometrics, mg/dL.;Serum insulin levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA)?µU/mL.;HOMA-IR. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Formula.;Body composition. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: body analyser.	—

Measure

Time frame

Glycated hemoglobin(HbA1C). Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Ion exchange chromatography.;Weight. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: scale, kilogram.;Waist circumference. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: meter, centimeter.;Body mass index. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: kg/m2, Weight/Height square.;Diastolic blood pressure. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: mmHg, Mercurial sphygmomanometer.;Systolic blood pressure. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: mmHg, Mercurial sphygmomanometer.;Fasting blood sugar. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: mg/dL, Colorimetric.;Serum Triglyceride levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: photometrics, mg/dL.;Serum total cholesterol levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: photometrics, mg/dL.;Serum Low-Density Lipoprotein cholesterol (LDL-c) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzymatic, mg/dL.;Serum High-Density Lipoprotein cholesterol (HDL-c) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: photometrics, mg/dL.;Serum insulin levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA)?µU/mL.;HOMA-IR. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Formula.;Body composition. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: body analyser.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAsma Salarimoghaddam

Isfahan University Of Medical Sciences

salarimoghaddam@hlth.mui.ac.ir+98 31 1792 2752

Outcome results

None listed

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