The effect of two types of low calorie diets on plasma levels of inflammatory factors in overweight or obese people with hypertriglyceridemia
Design
A randomized clinical trial with two-arm parallel-group, one will be put in an intermittent VLCD and the other group will have continuous calorie restriction, will start with a sample size of 80 in April 2020 and will be continued until June 2020.
Settings and conduct
Eighty obese or overweight subjects who volunteered by the advertisements will be assigned to the study groups and will be observed at the Nutrition and diet therapy Clinic of Shahid-Beheshti University of Medical Sciences. These individuals are divided into two groups. 1. intermittent calorie-restriction diet, or 2. continuous calorie restriction. At baseline and after two months of the diet, each person's plasma inflammatory factors will be measured and compared.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1- Body mass index more than 25
2-Age 18-60 years
3- non-smoker
4-Haven't has been under any diet at least 3 months before participating in the study
5-Not starting any new exercise program or changing the previous exercise while in the study
Exclusion Criteria:
1-Chronic kidney disease stage 3-5
2-Consuming Insulin or Insulin-inducing drugs
3-Consuming Omega 3 supplement
4-A history of cholecystitis
5- Heart arrhythmia
Intervention groups
Group1: Participants will have a very low-calorie diet (VLCD) 3 days a week (alternate-days ), which provides only 30% of the individual's energy requirement for weight maintenance. However, they will receive 100% of their daily need for energy for the remaining 4 days of the week.
Group 2: Participants will follow a classic calorie-restricted diet with a 30% reduction in daily energy requirement for weight maintenance.
Main outcome variables
Plasma C-Reactive Protein
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160702028742N7
Registration date:2020-03-19, 1398/12/29
Registration timing:registered_while_recruiting
Last update:2020-03-19, 1398/12/29
Update count:0
Registration date
2020-03-19, 1398/12/29
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
2019-04-12, 1398/01/23
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Intermittent Calorie Restriction on Inflammatory Markers in Overweight and Obese Adults
Public title
Effects of Intermittent Calorie Restriction on Inflammatory Markers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Body Mass Index over than 25 kg/m2
Willing to participate in the study
Age between 18 to 60 years
non smoker
haven't been under any diet at least 3 months before participating in the study
not starting any new exercise program or changing the previous exercise while in the study
Exclusion criteria:
chronic kidney disease stage 3-5
consuming Insulin or Insulin-inducing drugs.
consuming omega 3 supplement
a history of cholecystitis
Heart arrhythmia
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization tool is a sealed envelope. Stratified block randomization will be employed to assign subjects to each of the two groups. Stratification subdivides patients into those with diabetes or without diabetes and in each stratum, blocks of size 4 (two intervention and two control) will be defined and then the patients within each block will be assigned to intervention receiving intermittent calorie-restriction diet (intervention group) or continuous calorie restriction diet (comparison group).
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
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
No. 46, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2019-06-19, 1398/03/29
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1398.019
Health conditions studied
1
Description of health condition studied
Overweight and obesity
ICD-10 code
ICD-10 code description
Overweight and obesity
2
Description of health condition studied
overweight and obesity
ICD-10 code
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Plasma C-reactive protein (CRP)
Timepoint
Baseline and the end of the study
Method of measurement
Turbidometric method using kits
2
Description
interleukin 6
Timepoint
Baseline and the end of the study
Method of measurement
ELISA
3
Description
interleukin 10
Timepoint
Baseline and the end of the study
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in the group will be on a very low-calorie diet (30% of the individual's energy requirement for weight maintenance) for 3 days throughout the week, and on other days they will have the calorie needed to maintain weight (100% of their daily need for energy).
Category
Treatment - Other
2
Description
Control group: Participants in this group will have a daily calorie restricted diet (calorie deficient equivalent to a 30% of one's energy requirement for weight maintenance).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nutrition and Diet therapy Clinic of Faculty of Nutrition Sciences and Food Technology, Shahid Behes
Full name of responsible person
Mahsa Maroofi
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
info@nnftri.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
No. 46, Hafezi street, Farahzadi blvd, Qods Town, Tehran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2236 0658
Email
jnasrollahzadeh@gmail.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
Mahsa Maroofi
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 46, Hafezi street, Farahzadi blvd, Qods Town, Tehran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
009822934770
Email
Mahwoon3424@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Javad Nasrollahzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 46, Hafezi street, Farahzadi blvd, Qods Town, Tehran
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
Mahsa Maroofi
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 46, Hafezi street, Farahzadi blvd, Qods Town, Tehran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
009822934770
Email
Mahwoon3424@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD