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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201105131485N3

Enrollment

Registered

2011-06-11

Start date

2010-08-23

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

Metabolic Syndrome.

Interventions

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 Irania

fat 20-25%, protein 15-17% All participants follow this diet for 6 weeks.

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.

Eligibility

Sex/Gender

Female

Age

20 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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.

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 10, Week 16. Method of measurement: high sensitive immunoturbidimetry, mg/dL.;Serum high sensitive tumor necrosis factor-alpha (hs TNF-a) 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.	—

Measure

Time frame

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-a) 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.

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Secondary

Measure	Time frame
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/d	—

Measure

Time frame

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/d

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhmad Esmaillzadeh

Isfahan University of Medical Sciences

esmaillzadeh@hlth.mui.ac.ir+98 31 1792 2720

Outcome results

None listed

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