Effect of mixed nuts consumption on bio markers of cardiovascular disease in overweight and obese adults with coronary heart disease
Design
A single center, randomized, not blinded, controlled clinical trial with 2 parallel groups design and 70 participants, started in February and will be continued until may 2020.
Settings and conduct
Eligible volunteers will be recruited from Modares hospital. The study is not blinded, randomized clinical trial with two parallel groups.In this study, 70 patients with coronary artery disease referred to the heart clinic, will be randomized into two groups, mixed nuts (20 percent of daily calories) or placebo (5 gram of oat bran) for 8 weeks. Fasting blood sample will be taken at the baseline and the end of study to measure plasma level of lipid profiles, glucose, Insulin, Adiponectin.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Body Mass Index over than 25 kg/m2; Willing to participate in the study; Having at least one of the cardiovascular risk factors (diabetes, elevated blood pressure, hyperlipidemia); Age between 35 to 75 years.Exclusion Criteria: Regular consumption of nuts more than 50 grams in a week; Regular consumption (more than once in a week) vitamin and minerals supplements during past month; Having chronic kidney disease
Intervention groups
Intervention group: Daily consumption of 20 percent of calories as mixed nuts for 8 weeks. This amount of nuts being given to participants as packaged unsalted and raw nuts including pistachios, almond, peanuts. in addition, subjects of intervention group will be given oat bran powder to be consumed in a daily basis (5 grams/day).
Control group: Daily consumption of 5 grams of bran powder (Contain of Oats Bran powder) for 8 weeks
Main outcome variables
LDL-cholesterol
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160702028742N6
Registration date:2020-03-19, 1398/12/29
Registration timing:prospective
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
2020-04-08, 1399/01/20
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
Effect of mixed nuts consumption on bio- markers of cardiovascular disease in overweight and obese adults with coronary heart disease
Public title
Effect of nuts consumption on cardiovascular bio-markers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Body Mass Index over than 25 kg/m2
Willing to participate in the study
Having at least one of the cardiovascular risk factors (diabetes, elevated blood pressure, hyperlipidemia)
Age between 35 to 75 years
Exclusion criteria:
Regular consumption of nuts more than 50 grams in a week
Regular consumption (more than once in a week) vitamin and minerals supplements during past month
Having chronic kidney disease
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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 and control groups.
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 National Nutrition and Food Technology Research Institute
Street address
No. 46, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2019-06-22, 1398/04/01
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1398.014
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
fasting plasma insulin
Timepoint
Baseline and the end of the study
Method of measurement
Elisa
Secondary outcomes
1
Description
Fasting plasma LDL-cholesterol
Timepoint
Baseline and the end of the study
Method of measurement
Plasma level, Enzymatic
2
Description
Fasting blood sugar
Timepoint
Baseline and the end of the study
Method of measurement
Serum level, Enzymatic method
Intervention groups
1
Description
Intervention group: Daily consumption of 20 percent of calories as mixed nuts for 8 weeks. This amount of nuts being given to participants as packaged unsalted and raw nuts including pistachios, almond, peanuts. Oat bran in amount of 5 g/day will also be consumed by patients of this group.
Category
Lifestyle
2
Description
Control group: Daily consumption of 5 grams of Bran powder (Contain of Oats Bran powder) for 8 weeks
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modares Medical andzxr Research Center
Full name of responsible person
Dr Saeed Alipour Parsa
Street address
Modares Hospital,Sadat Abad intersection, Yadegar Emam Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
s_alipour@sbmu.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
Matin Ghanavati
Position
Ph.D Student in Nutrition Sciences
Latest degree
Master
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 2236 0658
Email
ghanavati.matin@yahoo.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
Matin Ghanavati
Position
Ph.D. Student in Nutrition Sciences
Latest degree
Master
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 2236 0658
Email
ghanavati.matin@yahoo.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