The impact of Dietary Approach to Stop Hypertension eating plan on fasting blood glucose and lipid profiles in children with metabolic syndrome: A cross-over study
The objective: Evaluation the impact of a DASH diet on components of metabolic syndrome in children. Design: cross-over trial. Participants: matured female aged 13-18 y with metabolic syndrome based on ATPIII defenition that have no cardio-vascular; gastrointestinal, renal and liver disorders diseases or medication/supplement use. Exclusion criteria: incidence of gastrointestinal, renal and liver disorders; lack of adherence to the prescribed diets. Setting and conduct: Participants will be randomly assigned to take DASH diet or usual recommendations after a 2 wk run-in period. The participants will be randomly assigned to receive either a DASH diet or usual dietary recommendations, each for 6 week, followed by a 4-week washout period. Then the participants will move to the alternate arm. Appropriate statistical methods will be applied for data analyses. Interventions: DASH diet and usual dietary recommendations. Main outcomes: Anthropometric measures, blood pressure, biochemical measures including fasting plasma glucose, serum insulin, triglyceride, total-cholesterol, high density lipoprotein cholesterol (HDL-c)-, and low density lipoprotein cholesterol (LDL-c) will be measured at baseline and at the end of each intervention phase.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110191485N6
Registration date:2012-02-01, 1390/11/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-01, 1390/11/12
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
2011-10-19, 1390/07/27
Expected recruitment end date
2011-12-29, 1390/10/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of Dietary Approach to Stop Hypertension eating plan on fasting blood glucose and lipid profiles in children with metabolic syndrome: A cross-over study
Public title
The impact of Dietary Approach to Stop Hypertension eating plan on features of metabolic syndrome in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female; aged 13-18 y; having metabolic syndrome according to modified Adult Treatment Panel III definition; being mature, 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 such as multivitamin supplementation, appetite suppressive, omega-3 fatty acids, Aspirin, NSAIDs, etc in the past 6 months, lack of hormone therapy.
Exclusion criteria: incidence of gastrointestinal, renal, liver and thyroid disorders ; diabetes, rheumatoid arthritis, Lupus, sever infection; trauma; surgery; allergy; alterations in physical activity and supplement use; lack of adherence to the prescribed diets
Age
From 13 years old to 18 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
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 Ave
City
Isfahan
Postal code
Approval date
2011-09-03, 1390/06/12
Ethics committee reference number
390245
Health conditions studied
1
Description of health condition studied
Metabolic syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fasting blood sugar
Timepoint
In the beginning and at the end of each intervention phase
Method of measurement
Colorimetric by using glucose oxidize
2
Description
Systolic blood pressure
Timepoint
In the beginning and at the end of each intervention phase
Method of measurement
digital sphygmomanometer
3
Description
HDL-C
Timepoint
In the beginning and at the end of each intervention phase
Method of measurement
Commercial kits
4
Description
Total cholesterol
Timepoint
In the beginning and at the end of each intervention phase
Method of measurement
Commercial kits
5
Description
Triglyceride serum
Timepoint
In the beginning and at the end of each intervention phase
Method of measurement
Commercial kits
6
Description
Diastolic blood pressure
Timepoint
In the beginning and at the end of each intervention phase
Method of measurement
digital sphygmomanometer
Secondary outcomes
1
Description
Waist circumference
Timepoint
In the beginning and at the end of each intervention phase
Method of measurement
meter
2
Description
weight
Timepoint
In the beginning and at the end of each intervention phase
Method of measurement
Digital scale
Intervention groups
1
Description
DASH diet: 53-58% of calorie from carbohydrate, 15-18% from proteins, and 26-30% from fats. These patients will also be advised to increase their intakes of fruits and vegetables, low dairy products, whole grains and decrease their saturated fatty acids, total cholesterol, total fat, red meat and sweets intake.
Category
Treatment - Other
2
Description
Diet including usual dietary recommendations: information about healthy diet has been prescribed for this group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Food security and research center
Full name of responsible person
Management of the center, Dr Leila Azadbakht
Street address
School of Nutrition and Food Science, Isfahan university of medical sciences, Hezar Jerib Ave,
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
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
Dr Ahmad Esmaillzadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Isfahan university of medical sciences, Hezar Jerib Ave
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
Dr Ahmad Esmaillzadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Isfahan university of medical sciences,Hezar Jerib Ave
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 researc
Full name of responsible person
Dr Ahmad Esmaillzadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Isfahan university of medical sciences, Hezar Jerib Ave
City
Isfahan
Postal code
Phone
Fax
Email
Esmaillzadeh@hlth.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)