In a single-blind (supplement and exercise-supplement groups blinding), clinical trial, effects of Purslane seed (Portulaca oleracea. L) with resistance training on cathepsin S, cystatin C and C-reactive protein levels (respectively Cys C, Cat S and CRP) in women with diabetes type 2 was determined. The study population were included all women with diabetes type II in Sari city. 28 members of this community with a mean age of 52 years were divided into 4 groups with blocked randomization method. Inclusion criteria included diabetes type 2 and lack of exercise and exclusion criteria included health and drug therapy. Group A (7.5 g Purslane seed per day), group B (60 minutes resistance training, 3 days in a week), group C (did exercise as group B and used Purslane seed similar to group C) and group D (control). Amount of weight, Cat S, Cys C and CRP factors were measured before and after eight weeks. P-value less than 0.05 was considered statistically significant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030517249N3
Registration date:2015-05-23, 1394/03/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-23, 1394/03/02
Registrant information
Name
Farzanegi Parvin
Name of organization / entity
Islamic Azad University, Sari Branch
Country
Iran (Islamic Republic of)
Phone
+98 15 1213 3853
Email address
parvin.farzanegi@iausari.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Islamic Azad University, Sari branch
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-02-08, 1392/11/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Portulaca oleracea L consumption and regular exercise on some inflammatory markers in women with diabetes
Public title
Effects of exercise and consumption of Purslane seeds on diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Not participating in regular physical activity during the last 6 months, Type 2 diabetic patients over 44 years.
Exclusion criteria: History of cardiovascular disease, Smoking, Drug therapy (any drugs except Metformin) and if participant is healthy.
Age
From 44 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University Sari Branch
Street address
7th km of Sea Road, Sari, Mazandaran, Iran
City
Sari
Postal code
Approval date
2015-05-17, 1394/02/27
Ethics committee reference number
1394/15
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Cystatin C
Timepoint
Before and 8 weeks after intervention
Method of measurement
ELISA method
2
Description
Cathepsin S
Timepoint
Before and 8 weeks after intervention
Method of measurement
ELISA method
3
Description
CRP
Timepoint
Before and 8 weeks after intervention
Method of measurement
ELISA method
Secondary outcomes
1
Description
Body weight
Timepoint
Before and 8 weeks after intervention
Method of measurement
Scale
Intervention groups
1
Description
Supplement group were consumed daily 7.5 g Purslane seed powder (2.5 g with lunch mile and 5 g with diner mile) mixed with yogurt for 8 weeks.
Category
Other
2
Description
Exercise- supplement group were consumed daily 7.5 g Purslane seed powder (2.5 g with lunch mile and 5 g with diner mile) mixed with yogurt for 8 weeks and also, did resistance exercise with 40 to 50 percent One-repetition maximum by rubber band for 8 weeks, 3 sessions per week and 60 minutes per session.
Category
Other
3
Description
Exercise group did resistance exercise with 40 to 50 percent One-repetition maximum by rubber band for 8 weeks, 3 sessions per week and 60 minutes per session.
Category
Other
4
Description
The control group did not participate in any stages of study.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sarv club
Full name of responsible person
Roja Daliri
Street address
Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University, Sari branch
Full name of responsible person
Dr. Mohammad Farsi
Street address
7th km of Sea Road, Sari, Mazandaran, Iran
City
Sari
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, Islamic Azad University, Sari branch
Proportion provided by this source
100
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
Islamic Azad University, Sari Branch
Full name of responsible person
Parvin Farzanegi
Position
PhD
Other areas of specialty/work
Street address
7th km of Sea Road, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
+98 113305334
Fax
Email
parvin.farzanegi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Sari Branch
Full name of responsible person
Parvin Farzanegi
Position
PhD
Other areas of specialty/work
Street address
7th km of Sea Road, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
+1 133-032-3853
Fax
Email
parvin.farzanegi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Sari Branch
Full name of responsible person
Parvin Farzanegi
Position
PhD
Other areas of specialty/work
Street address
7th km of Sea Road, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
+1 133-032-3853
Fax
+98 11330323858
Email
Parvin.farzanegi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)