Comparison of the effect of Nigella sativa oil and placebo supplementation on flow mediated dilation (FMD) and vascular inflammatory biomarkers in subjects with cardiovascular disease risk factors
This clinical trial aims to assess the effect of Nigella sativa oil on flow mediated dilation (FMD) and vascular inflammatory biomarkers in subject with cardiovascular disease risk factors
Design
A single center, randomized, single blinded, controlled clinical trial with a parallel group design and 50 participants evaluating the effect of Nigella sativa oil on vascular function. Stratified block randomization will be employed to assign subject to each of the two groups.
Settings and conduct
Fifty patients with at least one cardiovascular risk factor, referred to Imam Reza (AS) Hospital, will be randomized into two groups, Nigella sativa oil (2 capsules of 500 mg per day) or mineral oil (2 capsules of 500 mg per day) for 8 weeks. Flow mediated dilation and plasma levels of ICAM-1 and VCAM-1 are measured at baseline and after 8 weeks . Patients did not know the type of intervention and the study was single blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Willingness to participate in the study; Age between 20-75 years; Having elevated at least one of cardiovascular disease risk factors( including Dyslipidemia or diabetes mellitus or hypertension or smoking).
Exclusion Criteria: Unwillingness to continue participation; BMI> 30; Patients on anticoagulant or nitrates drugs; Consumption of vitamins or minerals supplements during past month; Chronic kidney disease stage 4 or 5, pregnancy.
Intervention groups
Intervention group: receiving 2 capsules of 500 mg Nigella sativa oil daily for 8 weeks. Control group: receiving 2 capsules of 500 mg mineral oil daily for 8 weeks.
Main outcome variables
Flow mediated dilation (FMD); ICAM-1 and VCAM-1 inflammatory factors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201126049495N1
Registration date:2020-12-10, 1399/09/20
Registration timing:prospective
Last update:2020-12-10, 1399/09/20
Update count:0
Registration date
2020-12-10, 1399/09/20
Registrant information
Name
Hadi Emamat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5545 0314
Email address
hadiemamat@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Nigella sativa oil and placebo supplementation on flow mediated dilation (FMD) and vascular inflammatory biomarkers in subjects with cardiovascular disease risk factors
Public title
The effect of Nigella sativa oil on vascular function
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Age between 20-75 years
Having at least one of cardiovascular disease risk factors (including diabetes, dyslipidemia, hypertension, smoking )
Exclusion criteria:
having BMI>30
Patients on nitrate or anticoagulant drugs
Regular consumption (more than once in a week) of vitamins or minerals supplements during past month
Chronic kidney disease stage 4 or 5
pregnancy
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants will be randomly assigned, in a ratio of 1:1, to either Nigella sativa group or placebo group for 8 weeks. Stratified block randomization will be employed to assign subject to each of the two groups. Stratification subdivides patients into those with diabetes or without diabetes and in each stratum, block size of 4-6 will be used with a 1:1 randomization between the two groups in each block, i.e. each block will consist of 2-3 subjects for the intervention group and 2-3 subjects for the placebo group. the predetermined allocation sequence of each block will be based on a computer-generated randomization list. An online program will be used for this purpose (www.randomizer.org). For each stratum, 8 blocks of 4 to 6 will considered and the sequence of patients in each block will be determined using software. Half of numbers in each block will be for the nigella sativa group and the other half for the placebo group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are blinded of the type of supplement they are consuming, but the main investigator who assigns patients to intervention or placebo groups is not blinded. Nigella sativa oil and placebo supplements are given to patients in similar capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Islamic Republic of Iran Army University of Medical Sciences
Street address
The Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh street, West Fatemi street, Tehran