The Effects of Portulaca oleracea Extract capsule on inflammatory biomarkers, lipid profile and serum glucose, anthropometric indices and blood pressure in adult with Metabolic syndrome for prevention of heart disease.
People with metabolic syndrome according to the inclusion criteria were selected and randomly divided into 2 groups and control blood samples were taken, Height , weight, waist circumference and blood pressure were recorded, intervention group took purslane capsules for 2 months and the control group took placebo capsules. Experiments were repeated after 2 months, the results were analyzed using the spss software
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121920366N1
Registration date:2015-02-14, 1393/11/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-14, 1393/11/25
Registrant information
Name
Marjan Badakhanian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3380 3531
Email address
m.badakhanian@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Isfahan University of Medical Sciencesand Research Center of Isfahan University of Medical Sciences
Expected recruitment start date
2014-04-06, 1393/01/17
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Portulaca oleracea Extract capsule on inflammatory biomarkers, lipid profile and serum glucose, anthropometric indices and blood pressure in adult with Metabolic syndrome for prevention of heart disease.
Public title
The Effects of Portulaca oleracea Extract capsule on inflammatory biomarkers, lipid profile and serum glucose, anthropometric indices and blood pressure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: persons suffering from obesity as defined by the IDF (WC≥ 102 in men) and have 2 signs of the 4 following symptoms, the metabolic syndrome was diagnosed. In this study, the characteristics of metabolic syndrome will be considered, if the criteria were the terms of this syndrome (having 2 of the first 4), other criteria will be checked:
1-high blood pressure (systolic>130mhg and diastolic>85mmhg); 2-fasting blood glucose>100mg/dl; 3-TG>150mg/dl; 4-HDL<40mg/dl; -gender: male; no history of cancer, kidney, thyroid, diabetes, and anemia; lack of use of alcohol and drugs; no smoking history or drug allergy; no special diet; no change in medication in the last three months; lack of drugs that control blood sugar, lipid and blood pressure; no taking medications affecting inflammation, such as corticosteroids.
Exclusion criteria: during the study , patients who lose their inclusion criteria, including smoking; suffering from diseases such as heart problems , kidney , thyroid and digestive disorders and lack of cooperation.
Age
From 27 years old to 59 years old
Gender
Male
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Making Purslane extract capsule: Purslane Confirmed in the Department of Pharmacognosy , Faculty of Pharmacy, then, 20 kg of plants dried in the shade , with 150 liters of ethanol with maceration method for 4 days extraction was repeated three times. The extract was filtered through filter paper using a rotary evaporator ( Haydolf , Germany ) under the pressure of a vacuum pump with a pressure of 10 mbar and a temperature of 40 ° C Was solved. The concentrated extract mixtured with anhydrous calcium phosphate powder (di calcium phosphate), and then through a sieve size 20 (850/0 mm) was granulated and dried at 40 ° C. The dried granules were sifting with sieve size 20 again. Finally purslane capsules were made granules containing dried extract of Portulaca oleracea extract as much as 500 mg per capsule at the Isfahan School Pharmacy.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Postal code
Approval date
2013-10-28, 1392/08/06
Ethics committee reference number
392434
Health conditions studied
1
Description of health condition studied
Metabolic syndrome
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
serum high sensitive-C Reactive Protein (hs-CRP) levels
intervention group consume Purslane extract capsules. Two capsules 500 mg , one 30 minutes before breakfast and another 30 minutes before dinner.
Category
Treatment - Drugs
2
Description
control group consume placebo capsule for 2 months. 1 capsule 30 minutes before breakfast and 1 capsule 30 minutes before dinner. Placebo was made of calcium phosphate
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Oil Company hospital
Full name of responsible person
Mr Mokhtari
Street address
Isfahan Oil Company hospital- Artesh square- Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Isfahan University of Medical Science
Full name of responsible person
Peyman Adibi
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
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,Isfahan University of Medical Science
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, School of Nutrition- School Nutrition Research Center
Full name of responsible person
Miss Samadanian
Street address
School Nutrition Research Center, School Of Nutrition and Food Sciences, Isfahan University Of Medical Sciences, Hezar Jerib Street, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, School of Nutrition- School Nutrition Research Center
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Marjan Badakhanian
Position
MSc Student Of Nutrition
Other areas of specialty/work
Street address
Department Of Clinical Nutrition, School Of Nutrition and Food Sciences, Isfahan University Of Medical Sciences, Hezar Jerib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2752
Fax
Email
marjanbadakhanian@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Marjan Badakhanian
Position
MSc Student Of Nutrition
Other areas of specialty/work
Street address
Department Of Clinical Nutrition, School Of Nutrition and Food Sciences, Isfahan University Of Medical Sciences, Hezar Jerib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2752
Fax
Email
marjanbadakhanian@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Marjan Badakhanian
Position
MSc Student Of Nutrition
Other areas of specialty/work
Street address
Department Of Clinical Nutrition, School Of Nutrition and Food Sciences, Isfahan University Of Medical Sciences, Hezar Jerib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2752
Fax
m.badakhanian@nutr.mui.ac.ir
Email
marjanbadakhanian@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)