Protocol summary

Summary
This randomized parallel clinical trial will be performed among overweight or obese (BMI>25 kg/m2)type 2 diabetic women aged 30-60 y. Individuals with the use of medications affecting inflammatory biomarkers and adipocytokines and also those with the chronic conditions affecting these biomarkers would not be included in the study. At baseline, we would have a 2-week run-in period for all participants. During this period, 3-day diet records as well as 3-day physical activity records would be collected. Then, after matching for age, BMI, current medication use and menopausal status, participants will be randomely assigned to consume low-energy dense diet, high-energy dense diet or usual diabetes meal plan for 8 weeks. Biochemical indicators (Fasting plasma glucose, serum insulin levels, serum lipid profiles, serum levels of hs-CRP, hs-TNF-alpha, hs-IL-6, Adiponectin, Visfatin and Chemerin)as well as anthropometric measures will be assessed at baseline and after 8 weeks. Low-energy dense diet would be a weight loss diet (-500kcal) containing 50-60% of energy from carbohydrates, 25% from fats and 15-20% from proteins. Individuals adhereing to this diet would have higher intakes of fruits, vegetables and beverages and lower intakes of dietary fat. High-energy dense diet would be a weight loss diet (-500kcal) containing 45-50% of energy from carbohydrates, 35% from fats and 15-20% from proteins. Individuals adhereing to this diet would have lower intakes of fruits and vegetables and higher intakes of dietary fat. Usual Diabetes meal plan would be a conventional weight loss diet (-500 kcal) containing 50-55% of energy from carbohydrates, 30% from fat and 15-20% from proteins. To assess compliance, participants will be asked to obtain a 24-hour dietary recall once in a 2 weeks during the study period. Also, they will be asked to obtain three daily physical activity records during this period. All biochemical measures and anthropometric assessments will be done at the end of trial.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105281485N4
Registration date: 2011-06-13, 1390/03/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-13, 1390/03/23
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
2010-11-22, 1389/09/01
Expected recruitment end date
2011-01-21, 1389/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of high versus low energy-dense diets on serum levels of adipokines and inflammatory biomarkers in type 2 diabetic women
Public title
Dietary energy density and type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diabetic non-pregnant and non-lactating females aged 30-60 y, Lack of insulin injection, non-smokers, lack of having a special diet except for usual diabetes meal plan, lack of sever weight loss in the last 3 months, not having sever infection in the last 3 months, trauma, surgery, hypo- and hyper-thyroidism, lack of the use of vasodialators, antioxidant supplements, vitamin and mineral supplements, diuretics, betablockers, garlet, OCP, aspirine and corticosteroids. Exclusion criteria: Lack of adherence to the prescribed diet, starting the use of above-mentioned medications or affecting by the above-mentioned diseases, alterations in dosage and type of current medications, getting pregnant
Age
From 30 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethical committee of isfahan university of medical science
Street address
Isfahan University of Medical Sciences, Hezar Jerib Ave, Isfahan
City
isfahan
Postal code
8174673461
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
189106

Health conditions studied

1

Description of health condition studied
diabetes
ICD-10 code
E11
ICD-10 code description
ديابت نوع 2 ، چاق، بزرگسالان، بالغين، غير كتوني، پايدار، نوع 2

Primary outcomes

1

Description
serum visfatin level
Timepoint
before the intervention week 8
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA) ،ng/dL

2

Description
serum adiponectin level
Timepoint
before the intervention week 8
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA) ،ug/dL

3

Description
serum chemerin level
Timepoint
before the intervention week 8
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA) ،ng/dL

4

Description
serum high sensitive Interleukin 6 (hs IL-6) levels
Timepoint
before intervention and week 8
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA) ،ng/dL

5

Description
serum high sensitive tumor necrosis factor-alpha (hs TNF-α) levels
Timepoint
before intervention and week 8
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA) ،mg/dL

6

Description
serum high sensitive-C Reactive Protein (hs-CRP) levels
Timepoint
before the intervention week 8
Method of measurement
high sensitive immunoturbidimetry, mg/dL

Secondary outcomes

1

Description
hip circumference
Timepoint
before the intervention week 8
Method of measurement
centimeter, meter

2

Description
body mass index
Timepoint
before the intervention week 8
Method of measurement
kg/m2, Weight/Height square

3

Description
Waist circumference
Timepoint
before the intervention week 8
Method of measurement
meter, centimeter

4

Description
Weight
Timepoint
before the intervention week 8
Method of measurement
scale, kilogram

5

Description
fasting blood sugar
Timepoint
before the intervention week 8
Method of measurement
mg/dL, Colorimetric

6

Description
serum insulin levels
Timepoint
before the intervention week 8
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA)،µU/mL

7

Description
serum Triglyceride levels
Timepoint
before the intervention week 8
Method of measurement
photometrics, mg/dL

8

Description
serum total cholesterol levels
Timepoint
before the intervention week 8
Method of measurement
photometrics, mg/dL

9

Description
serum Low-Density Lipoprotein cholesterol (LDL-c) levels
Timepoint
before the intervention week 8
Method of measurement
Enzymatic, mg/dL

10

Description
serum High-Density Lipoprotein cholesterol (HDL-c) levels
Timepoint
before the intervention week 8
Method of measurement
photometrics, mg/dL

Intervention groups

1

Description
High-energy dense diet : High-energy dense diet would be a weight loss diet (-500kcal)diet. this diet containing 45-50% of energy from carbohydrates, 35% from fats and 15-20% from proteins. Individuals adhereing to this diet would have lower intakes of fruits and vegetables and higher intakes of dietary fat.
Category
Treatment - Other

2

Description
low energy dense diet: Low-energy dense diet would be a weight loss diet (-500kcal)diet.this diet containing 50-60% of energy from carbohydrates, 25% from fats and 15-20% from proteins. Individuals adhereing to this diet would have higher intakes of fruits, vegetables and beverages and lower intakes of dietary fat.
Category
Treatment - Other

3

Description
normal diet:normal diet would be a weight loss diet (-500kcal)diet.this diet containing 50-55% of energy from carbohydrates, 30% from fats and 15-20% from proteins.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
health centres of Isfahan university of medical science
Full name of responsible person
Maryam Tabesh
Street address
Isfahan University of Medical Sciences, Hezar Jerib Ave, Isfahan
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
Dr. Adibi
Street address
Isfahan University of Medical Sciences, Hezar Jerib Ave, Isfahan
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
Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Esmaillzadeh
Position
PhD
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jerib Ave, Isfahan
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
Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Esmaillzadeh
Position
PhD
Other areas of specialty/work
Street address
School of nutrition,Isfahan University of Medical Sciences,Hezar Jerib Ave, Isfahan
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
Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Esmaillzadeh
Position
PhD
Other areas of specialty/work
Street address
School of nutrition,Isfahan University of Medical Sciences,Hezar Jerib Ave, Isfahan
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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