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Effect of whole grain consumption on inflammation

Effect of whole grain consumption or usual dietary recommendation on serum levels of inflammatory bio markers in obese children: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201305191485N10
Enrollment
44
Registered
2013-06-24
Start date
2012-07-01
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: whole-grain group:The individual energy requirements will be calculated based on recommendations of the Institute of medicine. The target macro nutrient composition for all participant
Treatment - Other
whole-grain group:The individual energy requirements will be calculated based on recommendations of the Institute of medicine. The target macro nutrient composition for all participants will be 53% of
Recommendation group: information about healthy diet has been prescribed for this group.Subjects in the non intervention group also were given a list of whole grain foods and will be asked not to cons

Sponsors

Vice Chancellor for Research, Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
8 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: female; aged 8-15 years; body mass index greater than 85th percentile for age and sex; lack of adherence to a specific diet and the use of medications and supplements and no history of chronic diseases. Exclusion criteria: history of chronic diseases; the use of medications and supplements such as multivitamin mineral supplementation, omega-3 fatty acids, Aspirin, etc in the past 6 months, hormone therapy and alterations in physical activity

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime 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 Amyloid A (SAA) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ?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 leptin levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ?ng/mL.

Secondary

MeasureTime frame
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.;Hip 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.;Systolic blood pressure. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: mmHg, digital sphygmomanometer.;Diastolic blood pressure. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: mmHg, digital 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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhmad Esmaillzadeh

Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medic

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

Outcome results

None listed

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