Investigation of the effect of two weeks supplementation with red Beet root and Prickly pear aqueous extract powder on the plasma Sirtuin 1 and homocysteine concentrations, SIRT-1 and LOX-1 gene expressions, and lipids profile in overweight and obese male patients with Coronary Heart Disease.
Objectives: The purposes of this study are the investigation and comparison of the effects of Red Beet Root and Prickly pear supplementation as the main dietary sources of Betalain, on some genes and risk factors related to Atherosclerosis in patients with Coronary Heart Diseases (CHD).
Design: At least 24 male patients with CHD, who will come to the Tabriz Shahid Madani Heart Hospital and have conditions for entering the study, would randomly be allocated to study arms where each arm consists of 12 patients.
Setting and conduct: The present study is a double-blind crossover randomized interventional clinical trial. At first, powdered red beetroot and prickly pear will be capsulated. Then interventions would be done. Before and after each period of intervention, blood collection for laboratory analysis would be conducted.
Participants: participants are males with CHD, 45-55 years old, BMI 25-35, who signed an informed consent and don’t change in exercise and fasting habits and drug administration during this study.
Intervention: The first group receives capsulated red beetroot for two weeks, followed by two weeks Placebo consumption, and after that, for two weeks they will receive capsulated Prickly Pear, and vice versa in the second group.
Main outcome: Measurement of Sirtuin-1 and Lectin-like oxidized low-density lipoprotein receptor 1 (LOX-1) genes expression, plasma levels of Sirtuin-1 protein, homocysteine and lipid profile are primary outcomes and measurement of Blood pressure and Fasting Blood Glucose are secondary outcomes.
General information
Acronym
CVD
CHD
IRCT registration information
IRCT registration number:IRCT2017092836469N1
Registration date:2017-11-20, 1396/08/29
Registration timing:registered_while_recruiting
Last update:
Update count:3
Registration date
2017-11-20, 1396/08/29
Registrant information
Name
Rahimi Parisa
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3570
Email address
parisa.rahimi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Tabriz University of Medical Science
Expected recruitment start date
2017-11-01, 1396/08/10
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of two weeks supplementation with red Beet root and Prickly pear aqueous extract powder on the plasma Sirtuin 1 and homocysteine concentrations, SIRT-1 and LOX-1 gene expressions, and lipids profile in overweight and obese male patients with Coronary Heart Disease.
Public title
supplementation in coronary heart disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1. Men Diagnosed with Coronary heart patients
2. 45-55 y of old
3. BMI (in kg/m2) of 25-35
4. No tobacco or alcohol consumption.
5. free of any serious and life-threatening illness, Malignancy, Cancer, Diabetes, Autoimmune disease, Infectious diseases, Anemia and with no stone maker kidney or bladder
6. Subjects with no history of allergic reaction to Beetroot or prickly pear
7. No changes in drug administration (patients only consume typical administered drugs for hypertension or dyslipidemia)
8. Subjects with no recent or current consumption of interventional supplements
9. Patients will be enrolled following an informed consent. The subject will be able to understand and comply with protocol requirements, instructions and protocol restrictions.
Exclusion criteria:
1. Myocardial Infarction
2. Strenuous exercise
3. Fasting
4. Allergic reactions
5. Any exposure or catch of infectious disease
6. Any side effect
7. Subjects with recent or current taking systemic medication (other than the usual drug for hypertension and dyslipidemia)
8. Patients with Failure to execute commands
9. Healthy subjects unwilling to consent
Age
From 45 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
Tehran, Jalal AleAhmad , Nasr
City
Tehran
Postal code
14115-111
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
IR.TMU.REC.1396.609
Health conditions studied
1
Description of health condition studied
Atherosclerotic Coronary Heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
2
Description of health condition studied
Atherosclerotic coronary heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Sirtuin-1 gene
Timepoint
days: 0, 14, 28, 42
Method of measurement
expression measurement with Real-Time PCR
2
Description
Lectin-like oxidized low density lipoprotein receptor-1 gene
Timepoint
days: 0, 14, 28, 42
Method of measurement
expression measurement with Real-Time PCR
3
Description
sirtuin-1 protein
Timepoint
days: 0, 14, 28, 42
Method of measurement
Concentration measurement with ELIZA
4
Description
Homocysteine
Timepoint
days: 0, 14, 28, 42
Method of measurement
Concentration measurement with ELIZA
5
Description
Lipids profile
Timepoint
days: 0, 14, 28, 42
Method of measurement
Concentration measurement with Enzyme, Autoanalyzer and formula
Secondary outcomes
1
Description
Fasting Blood Glucose
Timepoint
Days: 0, 14, 28 and 42
Method of measurement
spectrophotometric assay and autoanalyzer
2
Description
Blood pressure
Timepoint
days: 0, 14, 28 and 42
Method of measurement
digital blood pressure monitor
Intervention groups
1
Description
Intervention 1: In the first two weeks, 12 randomly selected male patients receive one 500 mg capsules of red beetroot powdered extract (freeze dried extract of red beet root juice from Beta vulgaris species which was processed in our laboratory, and is containing 25 mg betalains, a little sugar, protein and depleted of fiber. Also, cornstarch added to capsules as a filler) two times per day. In the second two weeks, they receive one 500 mg capsules of placebo (500 mg cornstarch), two times per day. And in the third two weeks, they receives one 500 mg capsules of prickly pear powdered extract (freeze dried extract of prickly pear fruit juice from Opuntia macrorhia species which was processed in our laboratory, and is containing 25 mg betalains, a little sugar, protein and depleted of fiber. Also, cornstarch added to capsules as a filler), two times per day.
Category
Treatment - Other
2
Description
Intervention 2: In the first two weeks, the other 12 randomly selected male patients receive one 500 mg capsules of prickly pear powdered extract (freeze dried extract of prickly pear fruit juice from Opuntia macrorhia species which was processed in our laboratory, and is containing 25 mg betalains, a little sugar, protein and depleted of fiber. Also, cornstarch added to capsules as a filler), two times per day. In the second two weeks, they receive one 500 mg capsules of placebo (500 mg cornstarch), two times per day. And in the third two weeks, they receives one 500 mg capsules of red beetroot powdered extract (freeze dried extract of red beet root juice from Beta vulgaris species which was processed in our laboratory, and is containing 25 mg betalains, a little sugar, protein and depleted of fiber. Also, cornstarch added to capsules as a filler) two times per day.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madany Medical Research Training center, Tabriz university of medical science
Full name of responsible person
Rahimi Parisa, PhD. student at clinical biochemistry---Dr. Separham Ahmad, Cardiologist and Associat
Street address
Tabriz-University Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tarbiat Modares University, Faculty of medical science
Full name of responsible person
Dr Mesbah-Namin Alireza
Street address
Tehran- Jalal AleAhmad- Nasr
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tarbiat Modares University, Faculty of medical science