Protocol summary

Study aim
The aim of present study is to determine the effect of menaquinone supplementation (MK-7) on metabolic, nutritional, inflammatory, and matrix γ-carboxyglutamat protein in people with type II diabetes.
Design
double blind randomized controlled trial, with parallel groups
Settings and conduct
Design of the study is a double-blind randomized controlled clinical trial with placebo and duration of intervention is 12 weeks. A total of 46 patients with type II diabetes will be included in the study after reviewing inclusion and exclusion criteria. At the beginning of the study, the dietary advice will be made available to all people according to the guidelines of the American Diabetes Association. Then subjects will enter in two groups of manaquinone and placebo. Demographic questionnaire will be completed at the beginning of the study but physical activity questionnaire (IPAQ), 3-day food record, anthropometric indices and body composition will be done at the end of the study. Also, at the beginning and the end of the study, 7 cc of venous blood will be taken and metabolic, nutritional, inflammatory and vitamin K level indicies will be measured.
Participants/Inclusion and exclusion criteria
In this study, non-menopausal women and men aged 20-55 years old and BMI of 27-35 with type 2 diabetes who control their disease with anti-diabetes drugs will be included in the study but insulin users or presence of any factors that affect the vitamin K status in the body will not be included in the study.
Intervention groups
The intervention and non-intervention group for three months will consume manaquinone supplement (200 mcg/day) and placebo (containing Microcrystalline cellulose), respectively.
Main outcome variables
Glycemic indexes, lipid profile, anthropometric and body composition indices, inflammatory status indicators, indicators of vitamin K status

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100123003140N22
Registration date: 2019-05-20, 1398/02/30
Registration timing: prospective

Last update: 2019-05-20, 1398/02/30
Update count: 0
Registration date
2019-05-20, 1398/02/30
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
Expected recruitment start date
2019-06-08, 1398/03/18
Expected recruitment end date
2019-10-10, 1398/07/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of menaquinone (MK-7) supplementation on metabolic, nutritional, inflammatory status and matrix γ- carboxyglutamate protein in DMII
Public title
Effect of menaquinone supplementation in DMII
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Men and non-postmenopausal women, With type 2 diabetes (at least from 6 months prior to the study), With desire to participate in the study, Age of 20-55 years, BMI 27-35 kg/m2, Who use anti diabetic drugs.
Exclusion criteria:
Pregnancy, lactation, menopause, hormone therapy, use of vitamin K containing contraceptives, polycystic ovary syndrome; Presence of diseases affecting vascular calcification or cardiac dysfunction; History of bone, rheumatoid arthritis, thyroid, parathyroid, liver, kidney, intestine disease or malignancies; Presence of infectious or inflammatory disease symptoms or recent surgery; Use of insulin, corticosteroids and anticoagulant drugs such as warfarin and coumarin; Adherence to a specific diet and consumption of any dietary supplements or weight reducing drugs for 3 month prior to the study; Smoking.
Age
From 20 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study will be divided into two groups using balanced block randomization: 1) menaquinone tablet consumer 2) placebo consumer First, the quadruple Blocks and arrangement of blocks with their numbering will be determined. Then after selection of specific blocks using a random number table and based on the number of blocks, entering the first four participants will be done. Then again, determination of the next block will be done using the random number table and this will continue until we reach the specified sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, neither the participants nor the researcher know which participants belong to the treatment group and which belong to the non-treatment group.
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
No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2019-04-25, 1398/02/05
Ethics committee reference number
IR.TBZMED.REC.1398.123

Health conditions studied

1

Description of health condition studied
Type II Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Blood levels of fasting glucose
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method

2

Description
Blood levels of fasting insulin
Timepoint
Before and after the intervention
Method of measurement
ELIZA KIT

3

Description
Serum levels of HbA1c
Timepoint
Before and after the intervention
Method of measurement
Spectrophotometry

4

Description
Insulin resistance index
Timepoint
Before and after the intervention
Method of measurement
Formula

5

Description
Blood levels of triglycerides
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method

6

Description
Blood levels of total cholestrol
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method

7

Description
Blood levels of HDL-cholestrol
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method

8

Description
Blood levels of LDL-cholestrol
Timepoint
Before and after the intervention
Method of measurement
Friedewald formula

9

Description
Anthropometric indices
Timepoint
Before and after the intervention
Method of measurement
Scale, Stadiometer,Tape

10

Description
Body composition indices
Timepoint
Before and after the intervention
Method of measurement
Impedance bio-electric system

11

Description
Serum levels of TNF-α
Timepoint
Before and after the intervention
Method of measurement
ELIZA KIT

12

Description
Serum levels of hsCRP
Timepoint
Before and after the intervention
Method of measurement
ELIZA KIT

13

Description
Serum levels of IL-6
Timepoint
Before and after the intervention
Method of measurement
ELIZA KIT

14

Description
Blood levels of dpucMGP
Timepoint
Before and after the intervention
Method of measurement
ELIZA KIT

15

Description
Blood levels of PIVKAII
Timepoint
Before and after the intervention
Method of measurement
ELIZA KIT

Secondary outcomes

1

Description
Dietary intake
Timepoint
Before and after the intervention
Method of measurement
Three day food record questionnaire

2

Description
physical activity level
Timepoint
Before and after the intervention
Method of measurement
IPAQ questionnaire

Intervention groups

1

Description
Intervention group: menaquinone supplement (in the form of MK-7), will be taken at a single daily dose of 200 microgram along with the main meal for a period of three months.The pure menaquinone supplement (DELTA, product of Kappa Bioscience AS, Norway, Denmark) will be introduced by Iran-based Mahbān-Daroo and supplement tablets will be provided by the professors of the School of Pharmacy.
Category
Other

2

Description
Control group: a single placebo tablet (containing microcrystalline cellulose) will be taken along with the main meal for a period of three months. Placebo tablets will be provided by the professors of the School of Pharmacy so that their shape and appearance look exactly like tablets of intervention group.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Salamat Specialist Polyclinics of Tabriz
Full name of responsible person
Dr. Esmaeil Faraji
Street address
Nyayesh Blvd, between pishghadam and sajjadiye, Salamat Specialist Polyclinics of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165741651
Phone
+98 41 3325 9774
Email
nahidkaramzad@gmail.com
Web page address
http://www.tabrizmodern.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem Jouyban
Street address
No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
ajouyban@hotmail.com
Web page address
https://researchvice.tbzmed.ac.ir/page/5/%D9%85%D8%B9%D8%A7%D9%88%D9%86-%D8%AA%D8%AD%D9%82%DB%8C%D9%82%D8%A7%D8%AA-%D9%88-%D9%81%D9%86%D8%A7%D9%88%D8%B1%DB%8C.html
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Bahram Pourghassem Gargari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
ۤFaculty of Nutrition and Food Science,Tabriz University of Medical Sciences, Golghast Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 2117
Fax
+98 41 3334 0634
Email
bahrampg@yahoo.com
Web page address
http://www.scopus.com/authid/detail.url?authorId=8561353400

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Bahram Pourghassem Gargari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Golghast Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 2117
Fax
+98 41 3334 0634
Email
pourghassemb@tbzmed.ac.ir
Web page address
http://www.scopus.com/authid/detail.url?authorId=8561353400

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Bahram Pourghassem Gargari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Golghast Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 2117
Fax
+98 41 3334 0634
Email
bahrampg@yahoo.com
Web page address
http://www.scopus.com/authid/detail.url?authorId=8561353400

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data
When the data will become available and for how long
After completing the study and publishing the articles
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
With the permission of the researcher and sponsor of the project
From where data/document is obtainable
Project researchers
What processes are involved for a request to access data/document
email or phone call
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