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IRCT201105131485N3 IRCT 2011-06-11 Vice chancellor for research,Isfahan University of Medical Sciences The effect of low-carbohydrate diet on inflammation Comparative effects of moderate carbohydrate restriction vs. high-carbohydrate diet on serum levels of adipocytokines, inflammatory indices and biomarkers of endothelial function among women with metabolic syndrome 2010-08-23 anticipated 40 Complete https://irct.ir/trial/765 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment. 2-3 Metabolic Syndrome. Intervention 1: Moderately carbohydrate-restricted diet: carbohydrate 43-47%; fat 36-40%, protein 15-17% 15-20% reduction in energy from carbohydrate will be replaced by non-hydrogenated vegetable oils. All participants follow this diet for 6 weeks. Intervention 2: Usual Iranian diet: carbohydrate 60-65%; fat 20-25%, protein 15-17% All participants follow this diet for 6 weeks.
public Ahmad Esmaillzadeh
Hezar Jerib Ave, Isfahan
Isfahan Iran (Islamic Republic of) +98 31 1792 2720 esmaillzadeh@hlth.mui.ac.ir Isfahan University of Medical Sciences scientific Ahmad Esmaillzadeh
Hezar Jerib Ave, Isfahan
Isfahan Iran (Islamic Republic of) +98 31 1792 2720 esmaillzadeh@hlth.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Being non-pregnant and non-lactating women; aged 20-65 y; having metabolic syndrome according to Adult Treatment Panel III definition; body mass index greater than 25 kg/m2; non-smokers; and lack of gastrointestinal, renal, liver and thyroid disorders; lack of diabetes, rheumatoid arthritis, Lupus; sever infection and trauma; surgery and allergy; lack of adherence to a specific diet and the use of medications in the last 3 months; having dietary carbohydrate intake between 35%-65% of total energy. Exclusion criteria: Pregnancy at any stage of the study; sever infection; trauma; surgery; allergy; alterations in physical activity and supplement use; lack of adherence to the prescribed diets. 20 years 65 years Female Lifestyle Lifestyle Moderately carbohydrate-restricted diet: carbohydrate 43-47%; fat 36-40%, protein 15-17% 15-20% reduction in energy from carbohydrate will be replaced by non-hydrogenated vegetable oils. All participants follow this diet for 6 weeks. Usual Iranian diet: carbohydrate 60-65%; fat 20-25%, protein 15-17% All participants follow this diet for 6 weeks. Serum high sensitive-C Reactive Protein (hs-CRP) levels. Timepoint: Week 2, Week 8, Week 10, Week 16. Method of measurement: high sensitive immunoturbidimetry, mg/dL. Serum high sensitive tumor necrosis factor-alpha (hs TNF-α) levels. Timepoint: Week 2, Week 8, Week 10, Week 16. 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 10, Week 16. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ،ng/dL. Serum Amyloid A (SAA) levels. Timepoint: Week 2, Week 8, Week 10, Week 16. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ،mg/dL. Serum E-selectin levels. Timepoint: Week 2, Week 8, Week 10, Week 16. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ،ng/dL. Serum Inter-Cellular Adhesion Molecule 1 (sICAM-1) levels. Timepoint: Week 2, Week 8, Week 10, Week 16. 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 10, Week 16. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ،µg/L. Serum leptin levels. Timepoint: Week 2, Week 8, Week 10, Week 16. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ،ng/mL. Serum adiponectin levels. Timepoint: Week 2, Week 8, Week 10, Week 16. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ،µg/mL. Weight. Timepoint: Week 2, Week 8, Week 10, Week 16. Method of measurement: scale, kilogram. Waist circumference. Timepoint: Baseline, Week 2, Week 8, Week 10, Week 16. Method of measurement: meter, centimeter. Hip circumference. Timepoint: baseline, week 2, week8, week 10, week 16. Method of measurement: centimeter, meter. Body mass index. Timepoint: Baseline, Week 2, Week 8, Week 10, Week 16. Method of measurement: kg/m2, Weight/Height square. Fat mass. Timepoint: Week 2, Week 8, Week 10, Week 16. Method of measurement: percent, Bioelectrical Impedance Analysis method. Fat free mass. Timepoint: Week 2, Week 8, Week 10, Week 16. Method of measurement: percent, Bioelectrical Impedance Analysis method. Systolic blood pressure. Timepoint: Baseline, Week 2, Week 8, Week 10, Week 16. Method of measurement: mmHg, digital sphygmomanometer. Diastolic blood pressure. Timepoint: Baseline, Week 2, Week 8, Week 10, Week 16. Method of measurement: mmHg, digital sphygmomanometer. Fasting blood sugar. Timepoint: Week 2, Week 8, Week 10, Week 16. Method of measurement: mg/dL, Colorimetric. Serum insulin levels. Timepoint: Week 2, Week 8, Week 10, Week 16. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA)،µU/mL. Serum Triglyceride levels. Timepoint: Week 2, Week 8, Week 10, Week 16. Method of measurement: photometrics, mg/dL. Serum total cholesterol levels. Timepoint: Week 2, Week 8, Week 10, Week 16. Method of measurement: photometrics, mg/dL. Serum Low-Density Lipoprotein cholesterol (LDL-c) levels. Timepoint: Week 2, Week 8, Week 10, Week 16. Method of measurement: Enzymatic, mg/dL. Serum High-Density Lipoprotein cholesterol (HDL-c) levels. Timepoint: Week 2, Week 8, Week 10, Week 16. Method of measurement: photometrics, mg/dL. Serum Blood Urea Nitrogen (BUN) levels. Timepoint: Week 2, Week 8, Week 10, Week 16. Method of measurement: photometrics, mg/dL. Serum creatinine levels. Timepoint: Week 2, Week 8, Week 10, Week 16. Method of measurement: photometrics, mg/dL. Vice chancellor for research,Isfahan University of Medical Sciences Approved 2010-08-09 Ethical Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib Ave, Isfahan Isfahan Iran (Islamic Republic of)