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
There are limited studies that have evaluated the effect of nutritional educations in patients with spinal cord injury (SCI). The purpose of this study was to evaluate the effect of nutritional education in diagnostic criteria of metabolic syndrome in patients with chronic SCI. Main inclusion criteria were: age over 18 years, at least 2 years post injury duration, traumatic injury and BMI over 22. Exclusion criteria were disorders of calcium metabolism, bone diseases and metabolic disorders. The study population is patients with SCI that have been referred to Brain and Spinal Injury Research Center from August 2014 till September 2015. The sample size is 52 persons. Patients in intervention group will receive special nutritional education (standard diet of low fat and low calorie) for six months. Weight, blood pressure, lipid profile indexes, blood glucose and liver enzymes will be measured at baseline and after 3 and 6 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406215968N3
Registration date:2014-08-07, 1393/05/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-07, 1393/05/16
Registrant information
Name
Hadis Sabour
Name of organization / entity
Brain and Spinal Injury Research Center (BASIR)
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1560
Email address
hsabour@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Brain and Spinal Injury Research Center (BASIR), Tehran University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Nutritional education effect on metabolic syndrome in patients with spinal cord inury
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Tehran University of Medical Sciences
Street address
Boulevard Keshavarz, Ghods st.
City
Tehran
Postal code
Approval date
2014-06-01, 1393/03/11
Ethics committee reference number
114766
Health conditions studied
1
Description of health condition studied
Metabolic Syndrom
ICD-10 code
E88.81
ICD-10 code description
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
2
Description of health condition studied
Spinal Cord Injury
ICD-10 code
S24
ICD-10 code description
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
Primary outcomes
1
Description
Cholesterol
Timepoint
At the baseline and then after 3 and 6 months
Method of measurement
Blood test
2
Description
Triglyceride
Timepoint
At the baseline and then after 3 and 6 months
Method of measurement
Blood test
3
Description
Low Density Lipoprotein (LDL)
Timepoint
At the baseline and then after 3 and 6 months
Method of measurement
Blood test
4
Description
High Density Lipoprotein (HDL)
Timepoint
At the baseline and then after 3 and 6 months
Method of measurement
Blood test
5
Description
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
6
Description
Waist circumstance
Timepoint
At the baseline and then after 3 and 6 months
Method of measurement
Direct measuremnet
7
Description
Fasting Blood Glucose
Timepoint
At the baseline and then after 3 and 6 months
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will receive standard nutritional care plus specific nutritional education (low fat, low calorie diets) for 6 months
Category
Lifestyle
2
Description
Control group will receive standard nutritional care