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IRCT201406215968N3 IRCT 2014-08-07 Brain and Spinal Injury Research Center Nutritional education effect on metabolic syndrome in patients with spinal cord inury Assessment of nutritional education of standard low fat and low calorie diets on reduction of risk factors of metabolic syndrome in comparison with control group in patients with chronic spinal cord injury 2014-07-23 anticipated 52 Complete https://irct.ir/trial/6438 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. N/A Condition 1: Metabolic Syndrom. Condition 2: Spinal Cord Injury. Intervention 1: Intervention group will receive standard nutritional care plus specific nutritional education (low fat, low calorie diets) for 6 months. Intervention 2: Control group will receive standard nutritional care.
public Hadis Sabour
Reihane Building, Imam Khomeini Hospital, Gharib Street, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) +98 21 6658 1560 hsabour@farabi.tums.ac.ir Brain and Spinal Injury Research Center scientific Mohammad Reza Vafa
Iran University of Medical Sciences, Hemat Highway
Tehran Iran (Islamic Republic of) +98 21 8860 2218 mrvafa@tums.ac.ir Nutrition Department, Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria are : Age above 18; Minimum time since injury of 2 years ; Traumatic injury; BMI higher than 22. Exclusion criteria are: Pregnancy; lactation; Previous history of diseases that affect bone metabolism such as Paget’s disease; primary hyperparathyroidism; osteomalacia; Clinical hypocalcemia; hypophosphatemia; Consumption of medications like calcitonin, floride, calciteriol, heparin, phenytoin, phenobarbital and estrogen in the past 6 months; Consumption of bisphosphonates or corticosteroids for more than 6 months; previous history of consumption of methotrexate or floride; Recent consumption of medications (either synthetic or herbal) with anti-platelet activity, tetracyclin, magnesium or zinc supplements; Previous history of liver diseases or any symptoms indicating liver diseases based on screening laboratory tests; Previous history of fracture of femur or spine in the past year (unrelated to the trauma); Previous history of allergy to fish or fish oil; Anemia (confirmed by hemoglobin or hematocrit measurement); Hypertension 17 years no limit Both E88.81 S24 Metabolic syndrome is a group of conditions that put you at risk for heart disease and diabetes. These conditions are high blood pressure high blood sugar levels high levels of triglycerides, a type of fat, in your blood low levels of hdl Injuries to the spinal cord (S24.0 and S24.1) refer to the cord level and not bone level injury, and can affect nerve roots at and below the level given Lifestyle Lifestyle Intervention group will receive standard nutritional care plus specific nutritional education (low fat, low calorie diets) for 6 months Control group will receive standard nutritional care Cholesterol. Timepoint: At the baseline and then after 3 and 6 months. Method of measurement: Blood test. Triglyceride. Timepoint: At the baseline and then after 3 and 6 months. Method of measurement: Blood test. Low Density Lipoprotein (LDL). Timepoint: At the baseline and then after 3 and 6 months. Method of measurement: Blood test. High Density Lipoprotein (HDL). Timepoint: At the baseline and then after 3 and 6 months. Method of measurement: Blood test. Body Mass Index (BMI). Timepoint: At the baseline and then after 3 and 6 months. Method of measurement: Measring weight and height and calculation of BMI. Waist circumstance. Timepoint: At the baseline and then after 3 and 6 months. Method of measurement: Direct measuremnet. Fasting Blood Glucose. Timepoint: At the baseline and then after 3 and 6 months. Method of measurement: Blood test. Brain and Spinal Injury Research Center Approved 2014-06-01 Ethics committe of Tehran University of Medical Sciences Boulevard Keshavarz, Ghods st. Tehran Iran (Islamic Republic of)