1. Home
  2. Approved trials
  3. » فارسی

The effects of omega-3 plus vitamin E, vitamin C plus zinc supplementation on serum lipids and lipoprotein profiles, inflammatory and oxidative stress biomarkers, and endothelial function in postmenopausal women with type 2 diabetes

Protocol summary

Summary
In this double blind randomized controlled clinical trial, we assessed the effects of omega-3 plus vitamin E and vitamin C plus zinc supplementation on serum lipids and lipoprotein profiles, inflammatory and oxidative stress biomarkers, as well as endothelial function in postmenopausal women with type 2 diabetes compared with the control group. In this 12-week trial, 75 postmenopausal women aged 50-65 years with type 2 diabetes participated from Iranian Diabetes Association. After obtaining the informed consent, subjects were assessed by dietary intake, anthropometric, clinical and medical history, and biochemical measurements. Subjects were randomly assigned to three groups to take 1) 1.8 g/day of omega-3 plus 400 mg/day vitamin E (group one), 2) five mg/day zinc plus 300 mg/day vitamin C (group two), 3) placebo (group three) for 12 weeks. During intervention period, individuals consumed their usual diet. They were assessed for cardiovascular risk factors, metabolic syndrome components, inflammation and oxidative stress biomarkers and endothelial function.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138804312214N1
Registration date: 2009-09-01, 1388/06/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-09-01, 1388/06/10
Registrant information
Name
Mohammad Reza Mahmoodi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1320 5056
Email address
mr_mahmoodi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Research Institute and Vice chancellor for Research of Kerman University of Medical Sciences
Expected recruitment start date
2008-03-19, 1386/12/29
Expected recruitment end date
2009-05-18, 1388/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of omega-3 plus vitamin E, vitamin C plus zinc supplementation on serum lipids and lipoprotein profiles, inflammatory and oxidative stress biomarkers, and endothelial function in postmenopausal women with type 2 diabetes
Public title
The effects of omega-3 plus vitamin E, vitamin C plus zinc supplementation on serum lipids and lipoprotein profiles, inflammatory and oxidative stress biomarkers, and endothelial function in postmenopausal women with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: willingness to participate in the study and sign the informed consent, postmenopausal women with age of 50 to 65 years, presence of type 2 diabetes at least for one year (according to the American Diabetes Association criteria), non-insulin therapy, receiving either diet therapy or diet therapy with combination of oral anti-diabetic medications, no history of myocardial infarction, stroke, cardiovascular disease, active cancer, liver, kidney and thyroid dysfunction, or infectious diseases, Exclusion criteria: changing in dose of medications such as oral anti-diabetic, anti-lipidemic and anti-hypertensive drugs, occurrence of myocardial infarction, stroke, active cancer, liver, kidney, thyroid dysfunction, or infectious diseases, changing in drug regimen or insulin therapy, smoking, consumption of anti-oxidant vitamin supplements and fish oil capsules, non-steroidal anti inflammatory drugs, corticosteroids, anti-platelets or anti-coagulation drugs three months prior to study, hormone replacement therapy.
Age
From 50 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
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
National Nutrition and Food Technology Research Institute
Street address
National Nutrition and Food Technology Research Institute, West Arghavan, Shaheed Farahzadi Blvd. Shahrak-E-Gharb Tehran, Iran. http://www.nnftri.ac.ir P.O. Box: 19395-4741
City
Tehran
Postal code
1981619573
Approval date
2008-12-01, 1387/09/11
Ethics committee reference number
25/47/5830

Health conditions studied

1

Description of health condition studied
Diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin dependent diabetes mellitus

Primary outcomes

1

Description
Fasting insulin serum
Timepoint
Baseline and after 12 weeks
Method of measurement
ELISA assay

2

Description
Fasting blood glucose
Timepoint
Baseline and after 12 weeks
Method of measurement
Glucose oxidase, Enzymatic colorimetric

3

Description
HbA1C (Glycosilated hemoglobin)
Timepoint
Baseline and after 12 weeks
Method of measurement
Ion exchange method

4

Description
Insulin resistance
Timepoint
Baseline and after 12 weeks
Method of measurement
HOMA-IR calculation

5

Description
Serum triglyceride
Timepoint
Baseline and after 12 weeks
Method of measurement
Glycerol phosphate oxidase, Enzymatic colorimetric

6

Description
Total cholestrol
Timepoint
Baseline and after 12 weeks
Method of measurement
Enzymatic photometric

7

Description
HDL-cholestrol
Timepoint
Baseline and after 12 weeks
Method of measurement
Enzymatic photometric

8

Description
LDL-cholestrol
Timepoint
Baseline and after 12 weeks
Method of measurement
Friedewald formula

9

Description
Apo lipoprotein B100
Timepoint
Baseline and after 12 weeks
Method of measurement
ELISA assay

10

Description
hsC-Reactive Protein
Timepoint
Baseline and after 12 weeks
Method of measurement
ELISA assay

11

Description
Tumor Necrosis Factor-α
Timepoint
Baseline and after 12 weeks
Method of measurement
ELISA assay

12

Description
Interleukin-6
Timepoint
Baseline and after 12 weeks
Method of measurement
ELISA assay

13

Description
Fibrinogen
Timepoint
Baseline and after 12 weeks
Method of measurement
ELISA assay

14

Description
tissue-plasminogen activator (t-PA)
Timepoint
Baseline and after 12 weeks
Method of measurement
ELISA assay

15

Description
Plasminogen activator inhibitor-1 (PAI-1)
Timepoint
Baseline and after 12 weeks
Method of measurement
ELISA assay

16

Description
Ox-LDL
Timepoint
Baseline and after 12 weeks
Method of measurement
ELISA assay

17

Description
Malonedialdehyde (MDA)
Timepoint
Baseline and after 12 weeks
Method of measurement
TBARS, Chemical colorimetric

18

Description
Total antioxidant capacity (TAC)
Timepoint
Baseline and after 12 weeks
Method of measurement
Colorimetric

19

Description
SOD
Timepoint
Baseline and after 12 weeks
Method of measurement
Kit Jaica

20

Description
GPX
Timepoint
Baseline and after 12 weeks
Method of measurement
Kit Jaica

21

Description
Arylesterase / Paraoxonase
Timepoint
Baseline and after 12 weeks
Method of measurement
Enzymatic colorimetric

22

Description
E-Selectin
Timepoint
Baseline and after 12 weeks
Method of measurement
ELISA assay

23

Description
sICAM-1
Timepoint
Baseline and after 12 weeks
Method of measurement
ELISA assay

24

Description
sVCAM-1
Timepoint
Baseline and after 12 weeks
Method of measurement
ELISA assay

25

Description
Systolic / Diastolic blood pressure
Timepoint
Baseline and after 12 weeks
Method of measurement
Mercurial Sphygmomanometer ALP K2

26

Description
Apo lipoprotein A1
Timepoint
Baseline and after 12 weeks
Method of measurement
ELISA assay

Secondary outcomes

1

Description
Medical events with special focus on cardiovascular
Timepoint
Baseline and every week until the end of intervention
Method of measurement
She was asked for any medical and activity conditions by investigator week to week or any time the patients want to call first executor and research doctor (councellor)

2

Description
Clinical and emotional improvement
Timepoint
Baseline and every week until the end of intervention
Method of measurement
She was asked for any medical and activity conditions by investigator week to week or any time the patients want to call first executor and research doctor (councellor)

Intervention groups

1

Description
1.8 g Omega-3 plus 400 mg vitamin E
Category
Treatment - Drugs

2

Description
300 mg Vitamin C plus 5 mg zinc
Category
Treatment - Drugs

3

Description
Placebo capsule containing 500 mg canola oil
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian Diabetes Society
Full name of responsible person
Asadollah Rajab (MD)
Street address
Iranian Diabetes Society, No 46. Ramin Malakuty Avenue, Patris Lomomba Avenue, Sattar Khan Street, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Dr Esmat Nasseri (Deputy of Research)
Street address
National Nutrition and Food Technology Research Institute, West Arghavan, Shaheed Farahzadi Blvd. Shahrak-E-Gharb
City
Tehran
Grant name
پروژه تحقیقاتی
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
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
Vice chancellor for Research of Kerman University of Medical Sciences.
Full name of responsible person
Professor Hamid Najafi pour
Street address
Vice chancellor for Research of Kerman University of Medical Sciences. Jahad Blvd. Ebn Sina Avenue
City
Kerman
Grant name
پروژه تحقیقاتی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research of Kerman University of Medical Sciences.
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

3

Sponsor
Name of organization / entity
Minami Nutrition Co.
Full name of responsible person
Jo Wyckmans
Street address
University Business Centre Antwerp, Drie Eikenstraat 661, 2650
City
Edegern
Grant name
پروژه تحقیقاتی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Minami Nutrition Co.
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

4

Sponsor
Name of organization / entity
PouraTeb Medical & Pharmaceutical Company
Full name of responsible person
Beheshti
Street address
Africa Street, higher than Mirdamad, next to Park Saba, East Pirouzi Alley, No.6
City
Tehran
Grant name
پروژه تحقیقاتی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
PouraTeb Medical & Pharmaceutical Company
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

5

Sponsor
Name of organization / entity
HakimanTeb Pharmaceutical Company
Full name of responsible person
Javad Jafari
Street address
Mohseni Square, Shah Nazari Street, Nahid Tower, 2nd Floor
City
Tehran
Grant name
پروژه تحقیقاتی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
HakimanTeb Pharmaceutical Company
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
Department of Nutrition, School of Health
Full name of responsible person
Mohammad Reza Mahmoodi
Position
PhD
Other areas of specialty/work
Street address
Department of Nutrition, School of Health, Haftbagh-E-Alavi Highway,
City
Kerman
Postal code
7616913555
Phone
+98 34 1320 5056
Fax
+98 34 1320 5134
Email
mr_mahmoodi@kmu.ac.ir , mahmoodimr@yahoo.com
Web page address
www.kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Nutrition, School of Health
Full name of responsible person
Mohammad Reza Mahmoodi
Position
PhD
Other areas of specialty/work
Street address
Department of Nutrition, School of Health, Haftbagh-E-Alavi Highway,
City
Kerman
Postal code
7616913555
Phone
+98 34 1320 5056
Fax
+98 34 1320 5134
Email
mr_mahmoodi@kmu.ac.ir , mahmoodimr@yahoo.com
Web page address
www.kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Department of Nutrition, School of Health
Full name of responsible person
Mohammad Reza Mahmoodi
Position
PhD
Other areas of specialty/work
Street address
Department of Nutrition, School of Health, Haftbagh-E-Alavi Highway,
City
Kerman
Postal code
7616913555
Phone
+98 34 1320 5056
Fax
+98 34 1320 5134
Email
mr_mahmoodi@kmu.ac.ir , mahmoodimr@yahoo.com
Web page address
www.kmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...