The effect of a balanced low-calorie diet on plasma lipid and lipoprotein concentrations in two groups of obese or overweight individuals, one group of non-statin users, and the other group of statin-treated groups will be examined.
Design
The study has a parallel design.
Settings and conduct
Among the volunteers with inclusion criteria, based on whether the volunteers are being treated with statin drugs or not, they are assigned to one of the two groups:1- treated with statins and 2-not using statins. People in both groups will be put on the low-calorie diet for 2 months.
Participants/Inclusion and exclusion criteria
Inclusion:
BMI>25 kg/m2
No weight change of more than 1-2 kg in the past month
LDL-C less than 130 mg/dL
Taking statins for more than 2 months (participants in the statin group)
Exclusion:
Chronic kidney disease (Cr> 1.4 mg / dl), cancer, autoimmune or inflammatory diseases treated with corticosteroids
Pregnancy and lactation
Regular use of garlic pills, omega-3 supplements, or flaxseed
Changes in medications during the study period
Intervention groups
1. Low calorie diet in people who do not use lipid lowering drugs
2. Low calorie diet in people who are on statin medications
Main outcome variables
Plasma total Cholesterol to HDL-cholesterol ratio
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160702028742N10
Registration date:2021-01-30, 1399/11/11
Registration timing:prospective
Last update:2021-01-30, 1399/11/11
Update count:0
Registration date
2021-01-30, 1399/11/11
Registrant information
Name
Javad Nasrollahzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 0656
Email address
jnasrolah@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-06, 1399/11/18
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of weight loss diet with and without statin medication on plasma lipid profile
Public title
Effects of weight loss with blood lipid-lowering medication on blood lipid concentration
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
BMI>25 kg/m2
No weight change of more than 1-2 kg in the past month
LDL-C less than 130 mg/dL
Taking statins for more than 2 months (participants in the statin group)
Exclusion criteria:
chronic chronic kidney disease (Cr> 1.4 mg / dl), cancer, autoimmune or inflammatory diseases treated with corticosteroids
Pregnancy and lactation
Regular use of garlic pills, omega-3 supplements, or flaxseed
Changes in medications during the study period
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not 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
National Nutrition and Food Technology Research Institute Ethic Committee
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2021-01-10, 1399/10/21
Ethics committee reference number
IR.SBMU.nnftri.Rec.1399.056
Health conditions studied
1
Description of health condition studied
overweight and obesity
ICD-10 code
E66
ICD-10 code description
overweight and obesity
Primary outcomes
1
Description
Plasma total cholesterol to HDL-cholesterol ratio
Timepoint
Baseline and after 2 months
Method of measurement
Enzymatic
Secondary outcomes
1
Description
Plasma LDL-C
Timepoint
Baseline and after 2 moths
Method of measurement
Enzymatic
2
Description
Plasma TG
Timepoint
Baseline and after 2 moths
Method of measurement
Enzymatic
3
Description
CRP
Timepoint
Baseline and after 2 moths
Method of measurement
Turbidometry
4
Description
IL-6
Timepoint
Baseline and after 2 moths
Method of measurement
ELISA
5
Description
Plasminogen activator inhibitor-1
Timepoint
Baseline and after 2 moths
Method of measurement
ELISA
6
Description
Apolipoprotein B
Timepoint
Baseline and after 2 moths
Method of measurement
Turbidometry
Intervention groups
1
Description
Intervention group: Overweight or obese people who have been regularly taking statins before starting the study are put on a healthy low-calorie diet.
Category
Lifestyle
2
Description
Control group: Overweight or obese people who have not been taking statins before starting the study are put on a healthy low-calorie diet.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Outpatient Diet Therapy Clinic
Full name of responsible person
Javad Nasrollahzadeh
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2237 6478
Email
jnasrollahzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2236 0658
Email
nnftri_food@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Javad Nasrollahzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
jnasrollhzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Javand Nasrollahzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
jnasrollahzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Javand Nasrollahzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
jnasrollahzadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available