Protocol summary

Summary
Design: cross-over clinical trial. Participants: obese girls aged 8-15 years that were recruited from a private clinic of a pediatrician. The objective: Evaluation the impact of whole-grain consumption on serum levels of adipocytokines and inflammatory bio markers in obese children. Exclusion criteria: history of chronic diseases such as cardiovascular disease (CVD), medication and supplementation use. Setting and conduct: After a 2 week run-in period, participants will be randomly assigned to whole-grain and recommendation group each for 6 weeks. After the first phase of intervention, a 4-week washout period will be applied. Then the participants will be crossed over to the alternate group for additional 6 weeks. To assess the compliance of the participants, we will assess dietary intakes of subjects by the use of dietary records once in every two weeks. Physical activity levels will also be assessed by a physical activity record once in every two weeks. Anthropometric measurements and biochemical assessments including fasting plasma glucose, triglyceride, total-cholesterol, high density lipoprotein cholesterol (HDL-c)-, and low density lipoprotein cholesterol (LDL-c), high sensitivity C-Reactive Protein (hs-CRP), serum amyloid A (SAA), serum inter-cellular adhesion molecule (sICAM-1), serum vascular cell adhesion molecule (sVCAM-1), leptin levels will be measured at the beginning and end of each phases. Appropriate statistical methods will be applied for data analyses. Interventions: usual dietary recommendation includes healthy food choices. First the individual energy requirements will be calculated. The target macro nutrient composition for all participants will be 53% of energy as carbohydrate, 30% of energy as fat and 17% of energy as protein. Subjects will be asked to obtain 50% of their grain servings from whole grain foods each day.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201305191485N10
Registration date: 2013-06-24, 1392/04/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-24, 1392/04/03
Registrant information
Name
Ahmad Esmaillzadeh
Name of organization / entity
Department of Nutrition, School of Public Health, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2791
Email address
esmaillzadeh@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2012-07-01, 1391/04/11
Expected recruitment end date
2012-09-01, 1391/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of whole grain consumption or usual dietary recommendation on serum levels of inflammatory bio markers in obese children: a randomized controlled trial
Public title
Effect of whole grain consumption on inflammation
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 8 years old to 15 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Simple randomization

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Postal code
Approval date
2012-06-10, 1391/03/21
Ethics committee reference number
191044

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
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

2

Description
Serum Amyloid A (SAA) levels
Timepoint
Week 2, Week 8, Week 12, Week 18
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA) ،mg/dL

3

Description
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

4

Description
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

5

Description
serum leptin levels
Timepoint
Week 2, Week 8, Week 12, Week 18
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA) ،ng/mL

Secondary outcomes

1

Description
weight
Timepoint
Baseline, Week 2, Week 8, Week 12, Week 18
Method of measurement
scale, kilogram

2

Description
Waist circumference
Timepoint
Baseline, Week 2, Week 8, Week 12, Week 18
Method of measurement
meter, centimeter

3

Description
hip circumference
Timepoint
Baseline, Week 2, Week 8, Week 12, Week 18
Method of measurement
meter, centimeter

4

Description
body mass index
Timepoint
Baseline, Week 2, Week 8, Week 12, Week 18
Method of measurement
kg/m2, Weight/Height square

5

Description
systolic blood pressure
Timepoint
Baseline, Week 2, Week 8, Week 12, Week 18
Method of measurement
mmHg, digital sphygmomanometer

6

Description
diastolic blood pressure
Timepoint
Baseline, Week 2, Week 8, Week 12, Week 18
Method of measurement
mmHg, digital sphygmomanometer

7

Description
fasting blood sugar
Timepoint
Week 2, Week 8, Week 12, Week 18
Method of measurement
mg/dL, Colorimetric

8

Description
serum Triglyceride levels
Timepoint
Week 2, Week 8, Week 12, Week 18
Method of measurement
photometrics, mg/dL

9

Description
serum total cholesterol levels
Timepoint
Week 2, Week 8, Week 12, Week 18
Method of measurement
photometrics, mg/dL

10

Description
serum Low-Density Lipoprotein cholesterol (LDL-c) levels
Timepoint
Week 2, Week 8, Week 12, Week 18
Method of measurement
Enzymatic, mg/dL

11

Description
serum High-Density Lipoprotein cholesterol (HDL-c) levels
Timepoint
Week 2, Week 8, Week 12, Week 18
Method of measurement
photometrics, mg/dL

Intervention groups

1

Description
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 energy as carbohydrate, 30% of energy as fat and 17% of energy as protein. Subjects in intervention group will be given a list of whole grain foods and will be asked to obtain 50% of their grain servings from whole grain foods each day
Category
Treatment - Other

2

Description
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 consume any of those foods during this period of study.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
private clinic of a pediatrician
Full name of responsible person
Mahin Hashemipor
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Payman Adibi
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medic
Full name of responsible person
Ahmad Esmaillzadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Postal code
Phone
+98 31 1792 2720
Fax
Email
Esmaillzadeh@hlth.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Food Security Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Esmaillzadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Postal code
Phone
+98 31 1792 2720
Fax
Email
Esmaillzadeh@hlth.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Community Nutrition, School of Nutrition and Food Science, Food Security and Research
Full name of responsible person
Ahmad Esmaillzadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Postal code
Phone
+98 31 1792 2720
Fax
Email
Esmaillzadeh@hlth.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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