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IRCT20100123003140N22 IRCT 2019-05-20 Tabriz University of Medical Sciences Effect of menaquinone supplementation in DMII Effect of menaquinone (MK-7) supplementation on metabolic, nutritional, inflammatory status and matrix γ- carboxyglutamate protein in DMII 2019-06-08 anticipated 46 Complete https://irct.ir/trial/39408 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, 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 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. 3 Type II Diabetes. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All data When: After completing the study and publishing the articles To whom: Academic researchers Conditions: With the permission of the researcher and sponsor of the project Where to obtain: Project researchers How to obtain: email or phone call Comments:
public Dr. Bahram Pourghassem Gargari
ۤFaculty of Nutrition and Food Science,Tabriz University of Medical Sciences, Golghast Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3336 2117 bahrampg@yahoo.com Tabriz University of Medical Sciences scientific Dr. Bahram Pourghassem Gargari
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Golghast Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3336 2117 pourghassemb@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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. 20 years 55 years Both 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. E08 Diabetes mellitus due to underlying condition Other Placebo 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. 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. Blood levels of fasting glucose. Timepoint: Before and after the intervention. Method of measurement: Enzymatic method. Blood levels of fasting insulin. Timepoint: Before and after the intervention. Method of measurement: ELIZA KIT. Serum levels of HbA1c. Timepoint: Before and after the intervention. Method of measurement: Spectrophotometry. Insulin resistance index. Timepoint: Before and after the intervention. Method of measurement: Formula. Blood levels of triglycerides. Timepoint: Before and after the intervention. Method of measurement: Enzymatic method. Blood levels of total cholestrol. Timepoint: Before and after the intervention. Method of measurement: Enzymatic method. Blood levels of HDL-cholestrol. Timepoint: Before and after the intervention. Method of measurement: Enzymatic method. Blood levels of LDL-cholestrol. Timepoint: Before and after the intervention. Method of measurement: Friedewald formula. Anthropometric indices. Timepoint: Before and after the intervention. Method of measurement: Scale, Stadiometer,Tape. Body composition indices. Timepoint: Before and after the intervention. Method of measurement: Impedance bio-electric system. Serum levels of TNF-α. Timepoint: Before and after the intervention. Method of measurement: ELIZA KIT. Serum levels of hsCRP. Timepoint: Before and after the intervention. Method of measurement: ELIZA KIT. Serum levels of IL-6. Timepoint: Before and after the intervention. Method of measurement: ELIZA KIT. Blood levels of dpucMGP. Timepoint: Before and after the intervention. Method of measurement: ELIZA KIT. Blood levels of PIVKAII. Timepoint: Before and after the intervention. Method of measurement: ELIZA KIT. Dietary intake. Timepoint: Before and after the intervention. Method of measurement: Three day food record questionnaire. Physical activity level. Timepoint: Before and after the intervention. Method of measurement: IPAQ questionnaire. Tabriz University of Medical Sciences Approved 2019-04-25 Ethics committee of Tabriz University of Medical Sciences No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)