The effects of Silybum marianum (L.) Gaertn. (Silymarin) supplement consumption on metabolic status, Hs-CRP and oxidative stress in type 2 diabetic patients with overweight or obesity
(1) Objectives: In this study diabetic patients will be assessed in order to determine the effects of Silybum marianum (Silymarin) supplement consumption on metabolic status, Hs-CRP and oxidative stress in type 2 diabetic patients with overweight or obesity. (2) Design: This study will be conducted as a randomized controlled trial. (3) Setting and conduct: Subjects were randomly divided into two groups including 20 subjects (taking Silybum marianum extract (silymarin)) and control (placebo). For each patient anthropometric measurements (height, weight and BMI) will be assessed and general characteristics and 24-h food record questionnaire in order to assessment of food intake for 3 days a week at the baseline and end of the study will be filled. 8 cc fasting blood samples from each patient will be taken at the beginning and end of the intervention. (4) Participants including major eligibility criteria: Inclusion criteria consists of: At least 6 months history of diabetes; usage of blood sugar lowering drugs; age between 20 and 50 years old and Exclusion criteria are: Pregnancy; lactation; kidney; heart and inflammatory disease. (5) Intervention: Intervention groups will receive daily 3 tablets which each tablet contain 140 milligrams of silymarin with meal and control group use the same amount placebo tablets daily for 45 days. (6) Main outcome measures (variables): Fasting blood glucose levels, fasting serum insulin, insulin resistance, serum lipids, Hs-CRP and Indicators of oxidative stress including total antioxidant capacity, malondialdehyde, glutathione peroxidase and superoxide dismutase in both groups before and after the intervention will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309243140N13
Registration date:2013-11-16, 1392/08/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-16, 1392/08/25
Registrant information
Name
Bahram Pourghassem Gargari
Name of organization / entity
Health and Nutrition Faculty, Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1435 7580
Email address
pourghassemb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Silybum marianum (L.) Gaertn. (Silymarin) supplement consumption on metabolic status, Hs-CRP and oxidative stress in type 2 diabetic patients with overweight or obesity
Public title
The effects of Silybum marianum (L.) Gaertn. (Silymarin) supplement consumption on metabolic status, Hs-CRP and oxidative stress in type 2 diabetic patients with overweight or obesity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Type 2 diabetes for at least 6 months; age between 20-50 (both of gender) years and usage of blood glucose lowering drugs. Exclusion criteria: usage of nutritional supplements in the past 3 months or during the study; usage of insulin; Pregnancy or lactation; BMI more than 35 and lower than 27; Renal and liver failure; Cardiovascular disease; Thyroid disorders; History of allergy; Smoking; Alcohol usage; Following a specific diet; Taking corticosteroids or Immunosuppressive drugs,…
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golbad Street
City
Tabriz
Postal code
Approval date
2013-09-10, 1392/06/19
Ethics committee reference number
9289
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E10,E11,E1
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
Baseline and after 45 days of intervention
Method of measurement
Enzymatic colorimetric
2
Description
Insulin resistance
Timepoint
Baseline and after 45 days of intervention
Method of measurement
HOMA-IR calculation
3
Description
Fasting insulin serum
Timepoint
Baseline and after 45 days of intervention
Method of measurement
ELISA assay
4
Description
Lipid profiles (TC, TG, LDL-C, HDL-C)
Timepoint
Baseline and after 45 days of intervention
Method of measurement
Enzymatic methods for TC,TG and HDL-C For LDL-C : Freidwald’s formula: LDL-C = TC- HDL-C - (TG/5)
5
Description
Hs-CRP
Timepoint
Baseline and after 45 days of intervention
Method of measurement
immunoturbidimetry
6
Description
serum malondialdehyde (MDA)
Timepoint
Baseline and after 45 days of intervention
Method of measurement
spectrophotometry
7
Description
serum total antioxidant capacity
Timepoint
Baseline and after 45 days of intervention
Method of measurement
spectrophotometry
8
Description
GPX activity
Timepoint
Baseline and after 45 days of intervention
Method of measurement
spectrophotometry
9
Description
SOD activity
Timepoint
Baseline and after 45 days of intervention
Method of measurement
spectrophotometry
Secondary outcomes
1
Description
calorie and nutrients intake
Timepoint
before and after 45 dyas intervention
Method of measurement
24-h recall Questionnaire
2
Description
Anthropometric index(weight, height,WHR and Body Mass
Timepoint
before and after 45 days intervention
Method of measurement
Analogue scale for weight and weight(Kg)/Square Height for body mass index
3
Description
systolic and diastolic blood pressure
Timepoint
before and after 45 days intervention
Method of measurement
standard barometer
Intervention groups
1
Description
Intervention group will receive daily 3 tablets of silymarin with meal for 45 days (each tablets of silymarin contains 140 milligrams pure silymarin). silymarin tablets will be purchased from the Livergol ®; Goldaru Herbal Products Pharmaceutical Company. All the patients will receive the tablets on every two weeks base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews and 2-weeks check lists.
Category
Treatment - Drugs
2
Description
The control group will receive daily 3 tablets of placebo with meal for 45 days. (Placebo tablets will be produced at the faculty of pharmacy of Tabriz University of medical sciences).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
East Azerbayjan Diabetes Society
Full name of responsible person
Soraiya Ebrahimpour Koujan
Street address
East Azerbayjan Diabetes Society, Near Haj Ali Asghar Nazir Vand mosque, 24 yards Fatemi Street, North Ghatran Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Seyed Kazem Shakouri
Street address
Tabriz University of Medical Sciences, Golbad Street
City
Tabriz
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, Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Soraiya Ebrahimpour Koujan
Position
MSc student in nutrition sciences
Other areas of specialty/work
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street
City
Tabriz
Postal code
Phone
00
Fax
Email
nutri.seam1@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahram Pourghasem Gargary
Position
associate professor in nutrition sciences
Other areas of specialty/work
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
+98 41 1334 0634
Email
bahrampg@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Soraiya Ebrahimpour Koujan
Position
MSc student in nutrition sciences
Other areas of specialty/work
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street
City
Tabriz
Postal code
Phone
00
Fax
Email
nutri.seam1@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)