Protocol summary
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Study aim
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The aim of the present study is to investigate 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.
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Design
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Randomized double blind clinical trial with two arm parallel groups
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Settings and conduct
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Patients volunteering from Tabriz Diabetes Control Center under an endocrinologist with diagnosis of type 2 diabetes will be randomly assigned to one of the two supplement or placebo groups.The duration of the study will be 8 weeks. L-citrulline and placebo sachets will be coded by the person responsible for preparing them, and the main investigators and the patients will be blinded to the type of supplement each group receives.
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Participants/Inclusion and exclusion criteria
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46 patients with type 2 diabetes and BMI of 25-35 kg / m2 who have been diagnosed with a disease for at least 6 months will be included in the study. Pregnancy, lactation and menopause in women, taking insulin and developing cardiovascular, renal and hepatic diseases are among the exclusion criteria.
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Intervention groups
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Patients in the L-Citrulline group will use a 3 gram L-Citrulline sachet before their breakfast, daily. In the placebo group, the sachet will contain 3 grams of microcrystalline cellulose.
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Main outcome variables
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Nutritional status (anthropometric indices , and calorie and macronutrients intake), metabolic status (fasting blood glucose، insulin, HbA1c, Insulin resistance index (HOMA-IR) and lipid profiles (TC, TG, HDL-c LDL-c), oxidative status (total antioxidant capacity, glutathione peroxidase and superoxide dismutase and Malondialdehyde), inflammatory status (hs-CRP, IL-6 and TNF-α), serum levels of L-citrulline and NOx (nitrate and nitrite)
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100209003320N16
Registration date:
2019-06-26, 1398/04/05
Registration timing:
prospective
Last update:
2019-11-28, 1398/09/07
Update count:
2
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Registration date
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2019-06-26, 1398/04/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-07-11, 1398/04/20
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Expected recruitment end date
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2019-09-22, 1398/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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The effect of L-Citrulline in type 2 Diabetes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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.
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Age
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From 25 years old to 55 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
46
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-06-11, 1398/03/21
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Ethics committee reference number
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IR.TBZMED.REC.1398.216
2
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Ethics committee
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Approval date
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2019-10-21, 1398/07/29
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Ethics committee reference number
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IR.TBZMED.REC.1398.739
Health conditions studied
1
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Description of health condition studied
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Type 2 diabetes
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ICD-10 code
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E11
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ICD-10 code description
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Type 2 diabetes mellitus
Primary outcomes
1
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Description
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Anthropometric Indices
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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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)
2
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Description
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Calorie and macronutrients intake
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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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.
3
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Description
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Fasting blood sugare
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Enzymatic method
4
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Description
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Insulin
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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ELISA
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Description
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HbA1c
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Enzymatic method
6
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Description
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Lipid profile
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of total cholesterol, HDL- cholesterol and triglyceride through enzymatic methods and calculation of LDL- cholesterol by Friedewald equation
7
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Description
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Insulin resistance
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Insulin resistance with HOMA-IR and calculation by this equation : [fasting insulin (mU / ml) × fasting glucose (mg / dl)] / 405
8
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Description
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Oxidative stress indices
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of total antioxidant capacity, glutathione peroxidase, superoxide dismutase and malondialdehyde through spectrophotometric method
9
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Description
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Inflammatory indices
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of serum hs-CRP by immunoturbidometry method and serum IL-6, TNF-α, MCP1 and TLR4 by ELISA
10
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Description
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Serum levels of L-Citrulline
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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ELISA
11
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Description
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Serum nitrate and nitrite (NOx)
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Colorimetric with Griess Reagent
Secondary outcomes
1
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Description
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Physical activity level
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Via IPAQ questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Data collected for the primary outcomes will be shared.
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When the data will become available and for how long
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Access starting 12 months after publication
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To whom data/document is available
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The data will only be available for people working in academic institutions.
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Under which criteria data/document could be used
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The data of the present study will only be accessible by other researchers, for conducting meta-analysis.
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From where data/document is obtainable
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Ms. Samaneh Azizi, E-mail address: s.azizi296@gmail.com, cellphone number: 0098 9177200691
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What processes are involved for a request to access data/document
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The applicant should provide a brief description of the aims and methods of his his Meta-analysis. His request will be assessed and, if agreed, the data will be emailed to the applicant. All these procedures will take no longer than 15 days.
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Comments
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