Effects of comprehensive dietary advice on the physical and mental health of patients with ulcerative colitis during the remission phase: a parallel randomized controlled clinical trial

Figures & data

Table 1. Baseline characteristics of UC patients who received either dietary modification program in addition to usual care or just usual care.

Variables	Intervention group (n = 40)	Control group (n = 40)	p-values
Age (year) (means ± SE)	37 ± 2	40 ± 2	0.308^1
Female sex (no. (%))	23 (57.5)	19 (47.5)	0.370^2
Married (%)	26 (65)	34 (85)	0.039^2
Current smoker (no. (%))	2(5)	6(15)	0.263^2
Body weight (kg) (means ± SE)	71 ± 2	68 ± 2	0.328^1
BMI (kg/m2) (means ± SE)	25.4 ± 0.8	24.3 ± 0.6	0.266^1
Time since diagnosis (year) (means ± SE)	7.7 ± 0.9	4.5 ± 0.4	0.016^1
Ulcerative colitis extent (no. (%))
Proctitis	18(32)	6(15)	0.003^2
Left-sided	10(25)	6(15)
Rectosigmoiditis	5 (12.5)	15 (37.5)
Pancolitis	7 (17.5)	13 (32.5)
SCCAI (score) (means ± SE)	2.3 ± 0.2	2.2 ± 0.2	0.444^1
Fecal calprotectin (µg/g) (means ± SE)	280 ± 44	291 ± 50	0.878^1
CRP (mg/L) (means ± SE)	7.4 ± 0.9	7 ± 1	0.686^1
The number of Mesalazine 500 mg used by patients(means ± SE)	5.5 ± 0.3	5.2 ± 0.3	0.436^1

¹Calculated by Independent-Samples T test

²Calculated by Chi-square test.

BMI: Body mass index, SCCAI: Simple Clinical Colitis Activity Index, CRP: C-Reactive protein

Figure 1. Patients flow diagram.

Table 2. Dietary intakes of the participants throughout the study.

Variables	Intervention group (n = 38)	Control group (n = 38)	P-values^1
	Before After	Before after
Energy intake (kcal/d)	1943 ± 54	2117 ± 60	0.03
Carbohydrate (g/d)	280 ± 9	312 ± 10	0.02
Protein (g/d)	83 ± 3	75 ± 3	0.03
Total Fat (g/d)	63 ± 2	64 ± 3	0.81
Saturated fat (g/d)	16.5 ± 0.7	18.7 ± 0.6	0.01
Sugar (g/d)	67 ± 2	70 ± 4	0.49
Calcium (mg/d)	733 ± 39	833 ± 39	0.07
Iron (mg/d)	20 ± 1	21 ± 1	0.23
Zinc (mg/d)	9.8 ± 0.4	8.3 ± 0.3	0.002
Sodium (mg/d)	1172 ± 47	1913 ± 129	<0.001
Vitamin A (µg/d)	1029 ± 151	939 ± 107	0.62
Folate (µg/d)	345 ± 24	314 ± 27	0.38
Vitamin C (mg/d)	163.6 ± 9.2	139.9 ± 12.1	0.04
Lactose (g/d)	6.2 ± 0.6	9.4 ± 1.2	0.02
Cobalamin (µg/d)	3.2 ± 0.2	3.4 ± 0.1	0.68
Vitamin D (µg/d)	1.3 ± 0.2	0.6 ± 0.1	0.006
Fiber (g/d)	19.4 ± 0.8	18.6 ± 0.8	0.49
Caffeine (mg/d)	91 ± 7	93 ± 7	0.89

Data are presented as means ± SE

¹Calculated by Independent-Samples T Test

Table 3. Mental health, fatigue, and quality of life at the baseline and following 12-wk intervention in UC patients who received either dietary modification program in addition to usual care or just usual care.

Variables	Intervention group (n = 38)		P-values^1	Control group (n = 38)		P-values^1	P-values^2
	Baseline	End of trial		Baseline	End of trial
FSS
Fatigue	36.1 ± 2.5	30.2 ± 2.3	<0.001	32.5 ± 2.3	33.4 ± 2.8	0.88	<0.001
DASS-21
Depression	16.8 ± 1.8	13.4 ± 1.4	<0.001	14.2 ± 1.5	16 ± 2	0.08	0.003
Anxiety	14.7 ± 1.7	11.2 ± 1.5	<0.001	11.2 ± 1.6	11.4 ± 1.5	0.81	0.001
Stress	19.3 ± 1.4	15.3 ± 1.2	<0.001	19.5 ± 1.9	20.20 ± 2.05	0.51	<0.001
SF-36
Physical functioning	78.8 ± 3.1	75.9 ± 2.2	0.25	82.0 ± 3.6	74.4 ± 3.3	0.13	0.88
Role-physical	62.2 ± 6.1	48.0 ± 3.4	0.06	80 ± 5	41.7 ± 4.1	<0.001	0.04
Bodily pain	55.4 ± 4.0	73.9 ± 1.2	<0.001	78.0 ± 3.7	70 ± 4	0.01	0.008
General health	46.8 ± 2.9	68.5 ± 1.2	<0.001	60.6 ± 2.7	62.0 ± 2.6	0.61	0.004
Vitality	53 ± 3	56.3 ± 1.3	0.31	54.9 ± 2.5	49.5 ± 2.9	0.11	0.06
Role-emotional	54.9 ± 7.5	48.07 ± 3.01	0.46	57.2 ± 6.7	44.4 ± 3.9	0.05	0.18
Social functioning	58.7 ± 3.8	75.2 ± 1.1	<0.001	70.6 ± 4.3	71.9 ± 2.5	0.78	0.24
Mental health	56.2 ± 3.5	61.1 ± 1.4	0.14	54 ± 4	55 ± 3	0.80	0.20

Data are presented as means ± SE

¹Calculated by Paired-Samples T test

²Calculated by ANCOVA, adjusted for baseline values and dietary energy intakes

Table 4. Metabolic profile at the baseline and following 12-wk intervention in UC patients who received either dietary modification program in addition to usual care or just usual care.

Variables	Intervention group (n = 38)		P-values^1	Control group (n = 38)		P-values^1	P-values^2
	Baseline	End of trial		Baseline	End of trial
FBG (mg/dl)	93.5 ± 1.6	91.5 ± 1.1	0.17	91.5 ± 2.2	91.3 ± 1.7	0.90	0.53
Total cholesterol (mg/dl)	167.5 ± 3.7	156.7 ± 1.5	0.22	157.88 ± 3.71	160.9 ± 2.8	0.42	0.11
Triglycerides (mg/dl)	106.10 ± 5.04	94.7 ± 4.6	0.12	112.7 ± 8.5	108.1 ± 5.5	0.47	0.37
LDL-cholesterol (mg/dl)	101.9 ± 3.5	92.3 ± 1.2	0.008	93.3 ± 3.8	93.3 ± 2.3	0.78	0.23
HDL-cholesterol (mg/dl)	44.3 ± 1.4	45.3 ± 0.6	0.39	42.02 ± 1.20	45.90 ± 1.02	0.004	0.60

Data are presented as means ± SE

¹Calculated by Paired-Samples T test

²Calculated by ANCOVA, adjusted for baseline values and dietary energy intakes