effect of substitution of animal proteins with plant proteins in DASH diet on glycemic indicators, lipid profile, Apo lipoproteins, Blood pressure and anthropometric indicators in obese individuals with metabolic syndrome
effect of substitution of animal proteins with plant proteins in DASH diet on glycemic indicators, lipid profile, Apo lipoproteins, Blood pressure and anthropometric indicators in obese individuals with metabolic syndrome
Design
clinical trial with control group with parallel group on 80 patients, double blind, random sequence
Settings and conduct
Eighty patients[intervention group (n = 40)] receive DASH diet containing 2/3 legumes and control group (n = 40) receive DASH diet containing 1/3 legumes refer to the Endocrinology and Metabolism Research Institute See. randomization and assign individuals to two intervention and control groups is hidden for laboratory expert and statistical analysis expert. At the end of the diet plan to reduce weight in patients, 500 kcal of total energy expenditure will be deducted. Biochemical indices and other measurements are assessed at baseline and after 8 weeks of intervention. Nutritional evaluation of individuals is conducted using a 24-hour recall twice a day and 10 ml of blood is taken after 12 hours of fasting.
Participants/Inclusion and exclusion criteria
inclusion criteria: BMI between 25 to 40 kg/m2, age between 30 to 60 years old, not having any specific diet, exclusion criteria: pregnancy , lactation, liver disease (non-alcoholic fatty liver Grade 3), , kidney disease (GFR <60 ml / min / 1.73 m2) and gastrointestinal disease, allergy and use of effective drugs in weight loss
Intervention groups
intervention group: dietary intake of DASH diet containing 2/3 legumes and 1/3 legumes
Main outcome variables
blood glucose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090203001640N16
Registration date:2020-01-13, 1398/10/23
Registration timing:prospective
Last update:2020-01-13, 1398/10/23
Update count:0
Registration date
2020-01-13, 1398/10/23
Registrant information
Name
Parvin Mirmiran
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Me
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2500
Email address
mirmiran@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of substitution of animal proteins with plant proteins in DASH diet on glycemic indicators, lipid profile, Apo lipoproteins, Blood pressure and anthropometric indicators in obese individuals with metabolic syndrome
Public title
ٍEvaluation of substitution of animal proteins with plant proteins in DASH diet in obese individuals with metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Agreement to participate in the study and completing informed consent form
aged 30-70 years old
No change in weight over the past 3 months
body mass index: 25-40
having Metabolic syndrome
Not having special diet
Non-pregnancy and lactation
Exclusion criteria:
Pregnancy and Lactation, having liver disease (non-alcoholic fatty liver Grade 3), kidney disease (GFR <60 ml / min / 1.73 m2), gastrointestinal disease, allergy.
Use of effective drugs in weight loss
Unwilling to consume legumes and nuts in the diet
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
This parallel-group randomized clinical trial will be conducted at Research Institute for Endocrine Sciences, SBMU, Tehran, Iran. In this study, patients will be divided into two groups [intervention(DASH diet containing 2/3 plant proteins and 1/3 animal proteins)] and control (DASH diet containing 2/3 animal protein and 1/3 plant proteins) by using random sequence. The allocation ratio will be 1:1. For randomly assignment of patients to the two groups, stratified blocked randomization method will be used.The division of the strata is based on the sexuality so that patients are first classified into men and women groups. After specifying four blocks in different layouts random selection approach will be used to set the allocation of treatment. the allocation of both groups will be concealed from main researcher in the biochemical laboratories and statistician who will analyze the data and the codes that will be placed to the packets will be available to the researchers for random sampling.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is designed as a double blind study. The main researcher and patients are not aware which DASH diet group contains 2/3 plant proteins or 2/3 animal proteins, and the main investigator is not involved in the randomization process
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of national nutrition and food technology research institute
Street address
No. 7, Shahid Farahzadi Blvd, Shahid Hafezi Street (West Arghavan), Qods Town (West), Tehran
City
Tehran
Province
Tehran
Postal code
19395-4741
Approval date
2019-06-19, 1398/03/29
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1398.033
Health conditions studied
1
Description of health condition studied
metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
metabolic syndrome
2
Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
serum concentration of blood glucose
Timepoint
befor the intervention and 8 weeks after intervention
Method of measurement
enzymatic method
Secondary outcomes
1
Description
serum concentration of total cholesterol
Timepoint
before the intervention and 8 weeks after intervention
Method of measurement
enzymatic method
2
Description
serum concentrations of triglyceride
Timepoint
before the intervention and 8 weeks after intervention
Method of measurement
enzymatic method
3
Description
Low density lipoprotein- cholesterol
Timepoint
before the intervention and 8 weeks after intervention
Method of measurement
enzymatic method
4
Description
high density lipoprotein- cholesterol
Timepoint
before the intervention, 8 weeks after intervention
Method of measurement
enzymatic method
5
Description
Serum concentration of Apolipoprotein- A1
Timepoint
before the intervention and 8 weeks after intervention
Method of measurement
enzymatic method
6
Description
Serum concentration of apolipoprotein- B
Timepoint
before the intervention and 8 weeks after intervention
Method of measurement
enzymatic method
7
Description
height
Timepoint
before the intervention and 8 weeks after intervention
Method of measurement
stadiometer
8
Description
weight
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
Seca scale
9
Description
blood pressure
Timepoint
before the intervention and 8 weeks after intervention
Method of measurement
Mercury barometer
10
Description
waist circumference
Timepoint
before the intervention and 8 weeks after intervention
Method of measurement
tape meter
Intervention groups
1
Description
Intervention group: DASH diet including 15% protein, 30% fat and 55% carbohydrate with intake of 2/3 proteins need from plant proteins( contain grains, nuts or seeds and legumes) and 1/3 animal proteins( contain milk, meat, cheese and eggs)
Category
Treatment - Other
2
Description
Control group: DASH diet including 15% protein, 30% fat and 55% carbohydrate with intake of 1/3 proteins need from plant proteins( contain grains, nuts or seeds and legumes) and 2/3 animal proteins( contain milk, meat, cheese and eggs)