create the summary of the finding "MATERIALS AND METHODS
The protocol of this randomized, double-blind, placebo-controlled clinical trial
was approved by the research Ethics Committee of Tehran University of
Medical Sciences (TUMS) and was registered in the Iranian Registry of Clinical
Trial (IRCT201106122602N6).
Male volunteers with SCI were referred to Imam Khomeini Hospital and
upon meeting the study criteria were enrolled into this study (from June 2012
to December 2013) after obtaining their consent. The inclusion criteria
1
Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran; 2
Neurosciences Research Center, Tabriz
University of Medical Science, Tabriz, Iran; 3
Department of Clinical Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran; 4
Drug and Poison
Information Center, Research and Development Office, Jundishapour University of Medical Sciences, Ahwaz, Iran; 5
Brain and Spinal Cord Injury Research Center, Neuroscience
Institute, Tehran University of Medical Sciences, Tehran, Iran; 6
School of Medicine, Azad University, Tehran, Iran and 7
Department of Biostatistics, School of Health Management
and Information Sciences, Iran University of Medical Sciences, Tehran, Iran
Correspondence: Professor S Eghtesadi, Department of Clinical Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran 1449614535, Iran.
E-mail: <PRESIDIO_ANONYMIZED_EMAIL_ADDRESS>
Received 23 June 2014; revised 28 January 2015; accepted 29 January 2015; published online 10 March 2015
Spinal Cord (2015) 53, 621–624
& 2015 International Spinal Cord Society All rights reserved 1362-4393/15
www.nature.com/sc
included complete SCI since at least 1 year with a maximum of 10 years, body
mass index (BMI)⩾18.5, age 30–50 years, no self-reported specific diseases and
malignancies, no vitamin and antioxidant supplementation and no smoking
and drinking. Study volunteers were excluded for failure to follow trial
guidelines (o80% compliance). Participants were randomly allocated to two
numerically equal groups from a double-blind, 70-person list, using a table of
random digits and given either 600 mg ALA or a placebo wheat flour capsule.
Study participants, as well as the placebo group, ingested those pills once daily
before breakfast for 12 weeks. Twelve participants were excluded during the
study (because of unwillingness, infection, ulcer, diarrhea and rash), which left
28 volunteers in the ALA group and 30 in the placebo group.
At the beginning of the study, written consent was obtained. Trained
personnel performed all data collection and measurements. Body weight for the
study participants was measured to the nearest 0.1 kg with minimal clothing by
means of a digital wheelchair balance. To measure height, knee height was
determined and the following formula22 was used: height in cm (for men)=
64.19− (0.04 × Age)+(2.02 × knee height in cm).
BMI was calculated for each patient (BMI=weight in kg/height2 in m).
Waist circumference was measured at the level of the iliac crest using an
Ergonomic Circumference Measuring Tape (model 201; Seca GmbH & Co.,
KG, Hamburg, Germany). Blood pressure was measured with a mercury
sphygmomanometer after 5 min of sitting rest. The average of three readings
was used for the waist circumference and blood pressure measurements. Food
intake was collected by 24-hour food recall (3-day recall before, and the same
after intervention). A nutritionist completed questionnaires during face-to-face
interviews. To assess energy and macronutrient intake, dietary data were
analyzed using Nutritionist IV software (Version 4.1, First Databank Division,
The Hearst Corporation, San Bruno, CA, USA).
After a 12 -h overnight fast, venous blood samples were collected. After
centrifugation, the serum samples were frozen and stored at − 70 °C.
All biochemical measurements were recorded in the Laboratory of Biochemistry, School of Public Health, Tehran University of Medical Sciences. IL-6 was
measured with ELISA (using a kit from Orgenium Company, Finland). The
method of measurement of hs-CRP was turbidimetry using Roche kits on the
Cobas Auto analyzer. Fasting blood sugar (FBS) was measured by means of an
enzymatic method (using a Hitachi 750 instrument, Elitech kit from Feppim
Company, French).
SPSS (version 16; SPSS Inc, Chicago, IL, USA) was used for all statistical
analyses. Descriptive statistics are presented as mean±s.d. The normality of
data was checked by the Kolmogorov–Smirnov test (K–S test). A paired t-test
(in case of normal distribiution) or a nonparametric statistical test, Wilcoxon
(in case of non-normal distribiution), was used for comparing data within
groups. An independent t-test (in case of normal distribution) or a nonparametric statistical test, Mann–Whitney (in case of non-normal distribiution),
was used for comparing data between two groups. Adjustment for differences
in baseline covariates and changes in variables during the study were studied by
means of analysis of covariance (ANCOVA). All tests were two-sided and
P-values o0.05 were considered statistically significant.
RESULTS
Baseline characteristics were similar in the ALA and placebo groups
(Table 1). No statistically significant differences were found for age,
weight, height and disease duration between the two groups.
After the intervention period no significant reduction was found in
IL-6 and hs-CRP levels. There was significant reduction in FBS, body
weight, BMI, waist circumference, blood pressure, carbohydrate,
protein, fat and energy intake (Table 2)"