3.1 Participants registration and Baseline characteristics
A total of 26 participants with SCI were enrolled for IF intervention, including 21 males and 5 females; 10 grade A, 7 grade B, 5 grade C, and 4 grade D; 8 cervical cord injury, 15 thoracic cord injury and 3 lumbar cord injury. The 13 participants in the IF group included 11 males and 2 females, and the 13 participants in the control group included 10 males and 3 females. Participants in the IF group failed to complete the test due to unbearable hunger, dizziness, and hypoglycemia, and 1 participants was discontinued due to failure to eat as required. Intestinal dysfunction (nausea, abdominal discomfort, and diarrhea) were IF found in 1 participant in the IF group and control group. In the IF group, 1 patient developed urinary system infection.
3.2 Baseline data comparison
In order to investigate whether there is a difference between the IF group and the control group, the baseline data, gender, age, course of disease, and basal plasma glucose of participants were tested. As shown in Table 1, the results showed that there were no significant differences in gender (P = 0.382), age (P = 0.136), disease course (P = 0.775), and blood sugar (P = 0.397) between the control group and the IF group. The results suggested that the two groups are comparable and the grouping is reasonable.
Table 1 Basic information of subjects
Parameter
|
Control group
(n=13)
|
Intermittent fasting group
(n=11)
|
P
|
Gender(man/female)
|
13/3
|
11/1
|
0.382
|
Age(year)
|
39.15±7.22
|
34.64±7.02
|
0.136
|
Course of disease (month)
|
16.62±12.65
|
15.09±13.08
|
0.775
|
Plasma glucose(mmol/L)
|
5.46± 0.40
|
5.59 ±0.32
|
0.397
|
Table 1 Basic information of subjects, including gender, age, course of disease, and baseline plasma glucose values.
3.3 Comparison of blood routine, liver and kidney function, electrolytes before and after intervention
In order to investigate the effects of IF on the physical function of the participants, the blood routine, liver function, kidney function, and electrolytes of participants were tested. As shown in Figure 1, compared with the control group, there were no significant differences in red blood cells (P = 0.693, 0.921, respectively), hemoglobin (P = 0.88, 0.909, respectively), alanine aminotransferase (P = 0.59, 0.402, respectively), aspartate aminotransferase (P = 0.16, 0.561, respectively), total protein (P = 0.492, 0.215, respectively), albumin (P = 0.211, 0.127, respectively), (P = 0.666, 0.992, respectively), creatinine (P = 0.611, 0.717, respectively), serum potassium (P = 0.613, 0.499, respectively), serum sodium (P = 0.119, 0.159, respectively), serum chlorine (P = 0.59, 0.144, respectively), serum calcium ( P = 0.919, 0.975, respectively) before and after IF intervention.
As shown in Figure 2, there were no significant differences in red blood cells (P = 0.115), hemoglobin (P = 0.123), alanine aminotransferase (P = 0.071), aspartate aminotransferase (P = 0.064), total protein (P = 0.089), albumin (P = 0.098), urea (P = 0.058), creatinine (P = 0.127), serum potassium (P = 0.135), serum sodium (P = 0.173), serum chlorine (P = 0.116), serum calcium (P = 0.185) before and after IF. The results suggested that IF is safe and feasible to participants with SCI.
3.4 Comparison of plasma glucose before and after intervention
In order to investigate the effect of IF on the plasma glucose of participants, the plasma glucose before dinner were tested every day. As shown in Figure 3, Repeated measures ANOVA revealed a significant main effect of group [F(1,22) = 226.734, P < 0.001], a main effect of day [F (27,594) = 1.648, P = 0.022], and a significant interaction between group and time [F(27,594) = 1.750, P = 0.012]. Due to the interaction effect, the t-test is used to analyze the daily blood glucose situation. The results showed that, compared with the control group, the plasma glucose of the IF group was significantly reduced from the 14th day (all P < 0.040), and the plasma glucose after the IF intervention was significantly lower than before (P = 0.038). The results suggested that IF can reduce plasma glucose in participants with SCI.
3.5 Comparison of body weight and BMI before and after intervention
In order to investigate the effect of IF on the weight and BMI of participants, which was tested. As shown in Figure 4, compared with the control group, there was no significant differences in body weight (P = 0.099) and BMI (P = 0.501) before IF intervention, and weight loss after intervention (P=0.043), but there was no significant difference in BMI index (P = 0.898). Moreover, there was significant differences in body weight and BMI before and after IF intervention (all P <0.001). The results suggested that IF can reduce the weight in participants with SCI.
3.6 Comparison of ASIA scores before and after intervention
In order to investigate whether IF can promote the recovery of dysfunction in participants with SCI, the participants’ ASIA scores was tested. As shown in Figure 4, compared with the control group, there was no significant difference in sensory function (P = 0.515, 0.469, respectively) and motor function (P = 0.892, 0.772, respectively) in the IF group before and after intervention, and the comparison before and after IF was also meaningless (P = 0.053, 0.054, respectively). The results suggested that IF didn’t promote the recovery of dysfunction in participants with SCI.