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IRCT20100209003320N16 IRCT 2019-06-26 Tabriz University of Medical Sciences The effect of L-Citrulline in type 2 Diabetes The effect of L-citrulline supplementation on nutrirtional, metabolic, oxidative and inflammatory status and serum levels of L-citrulline and NOx in type 2 diabetes patients: A randomized controlled clinical trial 2019-07-11 anticipated 46 Complete https://irct.ir/trial/40111 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 46 eligible patients will be randomly allocated to intervention and placebo groups using a software generated random permuted blocks. The generated random sequence will be kept in a protected location and administered by an independent third party who is blind to the trial throughout the study, Blinding description: In this study, the main investigators (including the student and her supervisors and adviser professors), as well as the patients will be blinded to the type of the supplement (L-citrulline or placebo) received by each group. The person responsible for preparing the supplement sachets (who is completely unrelated to the study) will be asked to assign a three-digit code to each of the two powders (L-citrulline and placebo) and keep the codes for himself until the end of the study and data analysis. 3 Type 2 diabetes. Intervention 1: Intervention group: Patients in this group will receive L-citrulline supplement for 8 weeks. The supplement is a sachet containing 3 grams of L-Citrulline (a product by Bulk Supplements Co. and made in the United States) which will be dissolved in a glass of water and used once a day before breakfast. Intervention 2: Control group: Patients in this group will receive placebo for 8 weeks. The placebo is a sachet containing 3 grams of microcrystalline cellulose (a product by Linyi Jindi Chemical Co. and made in China) which will be dissolved in a glass of water and used once a day before breakfast. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Samaneh Azizi
Faculty of Nutrition and Food Sciences., Attar Neishabouri St., Golghast St
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7582 s.azizi296@gmail.com Tabriz University of Medical Sciences scientific Dr. Mehrangiz Ebrahimi-Mameghani
Faculty of Nutrition and Food Sciences., Attar Neyshaburi St., Golghast St
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7582 ebrahimimamagani@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Suffering from type 2 diabetes that have passed at least 6 months since diagnosis and having HbA1c less than 9. Men and non-menopausal women Age 25 to 55 years BMI 25 to 35 kg/m2 People who control their diabetes just by using metformin and sulfonylurea Willingness to participate in the study 25 years 55 years Both Pregnancy, lactation or menopause in women Smoking or alcohol use A history of following a particular diet (at the time of the study or 3 months before the study) Change in the type or dosage of medications consumed, the type and amount of physical activity, changes in the diet at the start and during the study Using synthetic or herbal drugs for weight loss Use of any supplement (L-arginine, glutamine, multivitamin, antioxidant supplement, etc.) during the three months before or during the study. Taking insulin Suffering from cardiovascular disease, liver, intestinal, thyroid and parathyroid dysfunction, polycystic ovary syndrome, cancers and malignant diseases such as sprue and Crohn's disease Having symptoms of infectious or inflammatory disease or recent surgery The use of hypotensive and lipid-lowering drugs Use of corticosteroids and non-steroidal anti-inflammatory drugs for 3 months before the study. E11 Type 2 diabetes mellitus Treatment - Drugs Placebo Intervention group: Patients in this group will receive L-citrulline supplement for 8 weeks. The supplement is a sachet containing 3 grams of L-Citrulline (a product by Bulk Supplements Co. and made in the United States) which will be dissolved in a glass of water and used once a day before breakfast. Control group: Patients in this group will receive placebo for 8 weeks. The placebo is a sachet containing 3 grams of microcrystalline cellulose (a product by Linyi Jindi Chemical Co. and made in China) which will be dissolved in a glass of water and used once a day before breakfast. Anthropometric Indices. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of height and weight without shoes and with minimum clothes on, by Seca stadiometer and scale, respectively. Measurement of waist and hip circumference by a tape measure and body mass index (BMI) by dividing weight (kg) by height squared (m2). Calorie and macronutrients intake. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: The intake of calorie and macronutrients from the diet of the subjects with using a 3 day food record questionnaire and analysis by the nutritionist 4 program. Fasting blood sugare. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic method. Insulin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA. HbA1c. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic method. Lipid profile. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of total cholesterol, HDL- cholesterol and triglyceride through enzymatic methods and calculation of LDL- cholesterol by Friedewald equation. Insulin resistance. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Insulin resistance with HOMA-IR and calculation by this equation : [fasting insulin (mU / ml) × fasting glucose (mg / dl)] / 405. Oxidative stress indices. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of total antioxidant capacity, glutathione peroxidase, superoxide dismutase and malondialdehyde through spectrophotometric method. Inflammatory indices. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of serum hs-CRP by immunoturbidometry method and serum IL-6, TNF-α, MCP1 and TLR4 by ELISA. Serum levels of L-Citrulline. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA. Serum nitrate and nitrite (NOx). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Colorimetric with Griess Reagent. Physical activity level. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Via IPAQ questionnaire. Tabriz University of Medical Sciences Approved 2019-06-11 The Research Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Attar Neishabouri Ave., Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of) Approved 2019-10-21 The Research Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Attar Neishabouri Ave., Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)