Effects of ginger on serum concentrations of advanced glycosylation end products, oxidative stress, systemic and vascular inflammatory markers and lipoprotein (a) in peritoneal dialysis patients
The aim of this double-blind randomized clinical trial was to determine the effects of ginger on serum concentrations of advanced glycosylation end products, oxidative stress, systemic and vascular inflammatory markers and lipoprotein (a) in peritoneal dialysis patients. Thirty-four patients from Tehran peritoneal dialysis centers were randomly assigned to either supplement or placebo group. The patients in supplement group received 1000 mg ginger (as 4 capsules) daily for 10 weeks, while the placebo group received corresponding placebo. At the baseline and the end of the study,10 ml blood was collected from each patient after a 12-14-hours fasting and urinary albumin, serum pentosidine, carboxymethyl lysine, malondialdehyde, IL-6 ، hs-CRP ، sICAM-1، sVCAM-1, Lipid profile and Lp(a) were measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312062716N2
Registration date:2013-12-20, 1392/09/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-20, 1392/09/29
Registrant information
Name
Hadi Tabibi
Name of organization / entity
Department of Human Nutrition, Faculty of Nutrition Sciences and Food Technology,Shahid Beheshti Uni
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 7424
Email address
nsft@hbi.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Research Institute
Expected recruitment start date
2013-11-11, 1392/08/20
Expected recruitment end date
2014-02-02, 1392/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of ginger on serum concentrations of advanced glycosylation end products, oxidative stress, systemic and vascular inflammatory markers and lipoprotein (a) in peritoneal dialysis patients
Public title
Effects of ginger on cardiovascular risk factors in peritoneal dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: Continuous Ambulatory Peritoneal Dialysis for 6 months or more.
Exclusion criteria: infections; inflammatory diseases; thyroid disorders; gastrointestinal diseases; receiving anti-inflammatory drugs, thyroxine, warfarin, vitamins B6, E, C, and Omega-3 fatty acids supplement.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute
Street address
West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Postal code
Approval date
2013-06-22, 1392/04/01
Ethics committee reference number
049511
Health conditions studied
1
Description of health condition studied
cardiovascular risk factors in peritoneal dialysis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Malondialdehyde
Timepoint
Baseline and Week 10
Method of measurement
enzyme-linked immunosorbent assay (ELISA)
Secondary outcomes
1
Description
Serum pentosidine, carboxymethyl lysine, hs-CRP, IL-6, sICAM-1, sVCAM-1, TG, TC, LDL-C, HDL-C, apo AI, apo B100, Lp(a)
Timepoint
Baseline and Week10
Method of measurement
ELISA & Enzymatic method
Intervention groups
1
Description
Intervention: ginger supplement, Zintoma capsule,
Gol-Daru Company.
The patients in supplement group received 1000 mg ginger (as 4 capsules) daily for 10 weeks.
Category
Treatment - Drugs
2
Description
Control: placebo containing starch, Gol-Daru Company. The patients in the placebol group recieved daily 4 placebo capsules for 10 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor peritoneal dialysis Center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Dr. Fatemeh Mohammdi
Street address
46, West Arghavan St., Farahzadi Blv., Shahrak Qods,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and Food Technology Research Institute
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
Department of Clinical Nutrition & Dietetics, Faculty of Nutrition and Food Technology, Shahid Behes
Full name of responsible person
Dr. Hadi Tabibi
Position
PhD
Other areas of specialty/work
Street address
46, West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Postal code
Phone
+98 21 2207 7424
Fax
Email
hadtabibi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Clinical Nutrition & Dietetics, Faculty of Nutrition Sciences and Food Technology, Sha
Full name of responsible person
Dr. Hadi Tabibi
Position
PhD
Other areas of specialty/work
Street address
46, West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Postal code
Phone
+98 21 2207 7424
Fax
Email
hadtabibi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Clinical Nutrition & Dietetics, Faculty of Nutrition Sciences and Food Technology, Sha
Full name of responsible person
Dr. Hadi Tabibi
Position
PhD
Other areas of specialty/work
Street address
46, West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Postal code
Phone
+98 21 2207 7424
Fax
Email
hadtabibi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)