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

Phase 2

• Conditions: diabetes.; diabetes mellitus, adult-onset, nonketotic, stable, type II

• Registration Number: IRCT2013061613684N1
• Lead Sponsor: Vice chancellor for research,Isfahan 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: Female
• Target Recruitment: 30

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.