to compare effect of calorie restriction compared with no calorie restriction on blood pressure and plasma BDNF levels in overweight / obese patients undergoing stable treatment with antihypertensive drugs
Design
This is a parallel, non-blind, randomized clinical trial. In this study, participants who are eligible will be selected. Individuals are randomly assigned to one of two groups. The sequence of assigning individuals to the study groups is done using Random Allocation Software.
Settings and conduct
Overweight / obese people who regularly take high blood pressure medications are randomly assigned to one of two groups of low-calorie or regular non-calorie-restricted diets. The duration of the study will be 2 months. Patients with high blood pressure who are not calorie restricted are given general advice on daily consumption of vegetables, fruits and reducing salt intake. In both groups of calorie restriction, first the daily caloric requirement is calculated using the appropriate equation and coefficient of physical activity, and then about 500 calories are deducted from it, and the low-calorie diet using the substitution list method and the inclusion of all food groups Is set.
Participants/Inclusion and exclusion criteria
Inclusion:
• BMI>25
• age 40-70
• Regular use of antihypertensive drugs for at least the last 3 months
• non-smoker
• haven't been under any weight-loss diet at least 3 months before participating in the study
Exclusion:
• Taking antipsychotic, anticonvulsant drugs
• Cancer or chronic kidney disease stage 4-5
• Any changes in the disease treatment plan during the study, including changes in the type and dose of drugs used to affect blood pressure or surgery
• Pregnancy or breastfeeding
• Insulin treated patients
• Taking omega 3 supplement
Intervention groups
-Low-calorie diet
-Routine normal diet of the participants
Main outcome variables
Blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160702028742N11
Registration date:2022-01-29, 1400/11/09
Registration timing:prospective
Last update:2022-01-29, 1400/11/09
Update count:0
Registration date
2022-01-29, 1400/11/09
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
2022-02-19, 1400/11/30
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of calorie restriction on blood pressure and plasma brain-derived neurotrophic factor in overweight or obese subjects
Public title
Calorie restriction and plasma brain-derived neurotrophic factor
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a body mass index higher than 25
Regular use of antihypertensive drugs for at least the last 3 months
non-smoker
Haven't been under any weight-loss diet at least 3 months before participating in the study
Exclusion criteria:
Taking antipsychotic, anticonvulsant drugs
Cancer or stage 4 or 5 chronic or kidney disease
Pregnancy or breastfeeding
Any changes in the disease treatment plan during the study, including changes in the type and dose of drugs used to affect blood pressure or surgery•
Insulin treated patients
Taking omega 3 supplement
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
The sequence of assigning individuals to the study groups is done using Random Allocation Software. The sequence will be placed in a sealed opaque envelope.
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
The Ethic committeeof National Nutrition and Food Technology Research Institute
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2022-01-01, 1400/10/11
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1400.082
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Blood pressure
Timepoint
Baseline and the end of study
Method of measurement
Validated digital arm sphygmomanometer
Secondary outcomes
1
Description
Plasma brain-derived neurotrophic factor
Timepoint
Baseline and the end of study
Method of measurement
ٍ»]َُ
2
Description
Plasma ICAM-1
Timepoint
Baseline and the end of study
Method of measurement
ELISA
Intervention groups
1
Description
Intervention group: Low-calorie diet
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Nutrition Clinic
Full name of responsible person
Mahsa Maeroofi
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
193954741
Phone
+98 21 2237 6420
Email
jnasrollahzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
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
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, Hafezi Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
jnasrollahzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Javad Nasrollahzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, Hafezi 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
Javad Nasrollahzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, Hafezi ave, Farahzadi BLVD, Sanaat SQ
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
Undecided - It is not yet known if there will be 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