Evaluate the performance of three different diets (low calorie, balanced, low calorie - low carb and low calories - low fat) on high-sensitivity c-reactive protein and lipid profile in overweight adults aged 25-60 years
purpose of study: Evaluation of high sensitive c-reactive protein and lipid profile changes after using three kind of diet in overweight people who referred to Shiraz healthy heart house
Design of study:Randomized clinical trial (RCT), single blind, single-center
Study Population:People are overweight (BMI≥ 25) in order to assess their health status referring to Shiraz Healthy Heart Home.
Inclusion criteria: a certificate of age from 25 to 60 years; People with overweight (BMI ≥ 25). Exclusion criteria: Changes in diet; Hospitalization; time of sampling.
sample size:120 people. Interventions: group A: low calorie-balanced, group B: low calorie-low carbohydrate, group C: low calorie-low fat. Duration of intervention: 12 weeks. Outcomes of the study: A new model for nutritional intervention to reduce weight, reduce high-sensitivity C-reactive protein levels and improves lipid profile
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013100614914N1
Registration date:2014-09-09, 1393/06/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-09, 1393/06/18
Registrant information
Name
Afshin Lazarjani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 5975
Email address
lazarjani@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Shiraz University of Medical Sciences
Expected recruitment start date
2014-03-06, 1392/12/15
Expected recruitment end date
2014-06-05, 1393/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the performance of three different diets (low calorie, balanced, low calorie - low carb and low calories - low fat) on high-sensitivity c-reactive protein and lipid profile in overweight adults aged 25-60 years
Public title
Evaluate the performance of three different diets (low calorie, balanced, low calorie - low carb and low calories - low fat) on high-sensitivity c-reactive protein and lipid profile in overweight individuals
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Individuals must complete a consent form to participate in the project; a certificate of age from 25 to 60 years; no use of lipid-lowering medications; no history of kidney disease; liver disease; heart disease; thyroid disorders, diabetes; and rheumatologic diseases. Exclusion criteria: those who did not fill out a consent form or were withdrawn from the plan; Changes in diet; changes in daily physical activity; pregnancy; lactation or use of oral contraceptives; Conditions that require patients to lipid-lowering drugs; Alcohol consumption; Non-fasting blood samples; Hospitalization; time of sampling; Acute infectious diseases.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Postal code
7134814336
Approval date
2013-08-18, 1392/05/27
Ethics committee reference number
CT-P-92-4698
Health conditions studied
1
Description of health condition studied
Overweight
ICD-10 code
E66.9
ICD-10 code description
Overweight
Primary outcomes
1
Description
High-sensitivity c-reactive protein
Timepoint
Before the experiment, 12 weeks after the intervention.
Method of measurement
biochemical measurements on blood sample
2
Description
Serum triglycerides
Timepoint
Before the experiment,12 weeks after the intervention
Method of measurement
biochemical measurements on blood sample
3
Description
High-density lipoprotein
Timepoint
Before the experiment, 12 weeks after the intervention.
Method of measurement
biochemical measurements on blood sample
4
Description
low-density lipoprotein
Timepoint
Before the experiment, 12 weeks after the intervention.
Method of measurement
biochemical measurements on blood sample
5
Description
total cholesterol
Timepoint
Before the experiment, 12 weeks after the intervention.
Method of measurement
biochemical measurements on blood sample
Secondary outcomes
1
Description
Body Mass Index
Timepoint
Before the experiment, 12 weeks after the intervention.
Method of measurement
Calculated according to the formula
2
Description
Weight
Timepoint
Before the experiment, 12 weeks after the intervention.
Method of measurement
Electronic Scales
Intervention groups
1
Description
group A: low calorie-balanced:50-55% carbohydrate,12-15% protein,25-30% fat,500 kcal less than the daily intake for a period of three months from baseline
Category
Lifestyle
2
Description
group B: low calorie-low carbohydrate:35-40% carbohydrate,25-30% protein,<40% fat,500 kcal less than the daily intake for a period of three months from baseline
Category
Lifestyle
3
Description
group C: low calorie-balanced:45-60% carbohydrate,15-20% protein,<20% fat,500 kcal less than the daily intake for a period of three months from baseline
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiovascular Research Center of Shiraz University of Medical Sciences
Full name of responsible person
Afshin Lazarjani
Street address
Cardiovascular Research Center, Shahid Faghihi Hospital, Zand Blvd, Shiraz
City
Shiraz
2
Recruitment center
Name of recruitment center
Shiraz Healthy Heart Home
Full name of responsible person
Afshin Lazarjani
Street address
Shiraz, Modares Blvd, opposite St Fazilat, Center for Healthy Heart Home
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Midical Sciences
Full name of responsible person
Shahdad khosropanah
Street address
Cardiovascular Research center, Shahid Faghihi Hospital, Zand Blvd, Shiraz
City
Shiraz
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, Shiraz University of Midical 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
Shiraz University of Medical Sciences
Full name of responsible person
Shahdad Khosropanah
Position
Associate Professor of Cardiology
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1229 7767
Fax
Email
shahdad44@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Shahdad Khosropanah
Position
Associate Professor of Cardiology
Other areas of specialty/work
Street address
Cardiovascular Research center,Shahid Faghihi Hospital,Zand Blvd, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1229 7776
Fax
Email
shahdad44@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Afshin Lazrjani
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Postal code
Phone
00
Fax
Email
lazarjani@sums.ac.ir; afshin.lazarjani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)