Adherence to the Mediterranean Diet Improved Clinical Scores and Inflammatory Markers in Children with Active Inflammatory Bowel Disease: A Randomized Trial

Figures & data

Table 1 Demographic, Clinical and Laboratory Data of All Patients at Start of the Study

Variables	Group I (on MD) (N=50)	Group II (on Regular Diet) (N=50)	P value
Age (years)	13.8±2.6	13.1±1.9	0.185
Sex (male: female)	28:22	26:24	0.707
Type of IBD:
-UC	−24 (48%)	−22 (44%)	0.903a
-CD	−26 (52%)	−28 (56%)
Weight (kg)	31.6±7.1	30.5±6.8	0.284
Height (cm)	142.7±24.6	142.3±21.9	0.740
BMI	17.7±2.4	17.2±2.6	0.308
Serum Ca (mg/l)	9.5±1.8	9.4±1.7	0.944
PTH (pg/mL)	51.3±11.3	49.6±12	0.217
Serum vitamin D (ng/mL)	23.4±2.7	24.5±3.2	0.758
ESR (N 0–20 mm/h)	14.3± 12.1	15.7± 10.9	0.92
CRP (N< 10 mg/mL)	25.4 ± 18.1	27.1± 20.5	0.98
Calprotectin(N< 50 µg/g)	622.4± 411.5	645.8 ± 435.7	0.88
Albumin(N 3.5–5.5 g/Dl)	4.2± 0.9	4.1± 0.88	0.91
TNF-α (pg/mL)	18.9±3.8	17.8±2.7	0.696
IL-17 (pg/mL)	27.1±4.2	26.9±4.6	0.24
IL-10 (pg/mL)	6.5±1.3	6.6±1.4	0.652
IL-12 (pg/mL)	122.3±18.7	118.1±13.4	0.961
IL-23 (pg/mL)	60.7±9.6	58.9±7.7	0.591
Triglycerides(mg/dl	121.7 ± 55.6	110.9 ± 48.4	0.46
Cholesterol(mg/dl)	171.0 ± 38.6	188.6 ± 40.1	0.39
Glucose(mg/dl)	89.2± 21.2	87.7± 8.7	0.95
Hemoglobin(g/dl)	13.6 ±1.9	14.1 ±1.9	0.49
-PCDAI	31.4±5.1	30.8±5.5	0.344
-PUCAI	30.5±3.7	29±6.1	0.618
Duration of the disease (y)	3.1±1.6	3.4±1.3	0.624
Treatment received(during study):
- Glucocorticoids	19 (38%) (11 CD, 8 UC)	16(32%) (9 CD, 5 UC)	0.792a
-Immunomodulators	14 (28%) (7 CD, 7 UC)	11(22%) (6 CD, 5 UC)
-Biological	6 (12%) (4 CD, 2 UC)	8 (16%) (4 CD, 4 UC)
Antibiotics	16(32%) (10 CD, 6 UC)	18(36%) (10 CD, 8UC)
Aminosallicylate	5(10%) All were UC	6(12.5) All were UC
Enteral feeding	5(10%) (4 CD, 1 UC)	5(10%) (4 CD, 1 UC)
-Combination	13(26%) (7 CD.6 UC)	14(28%) (8 CD.6 UC)

Abbreviations: a, analysis was done by chi-square test; IBD, inflammatory bowel disease; UC, ulcerative colitis; CD, Crhon’s disease; BMI, body mass index; Ca, calcium; PTH, parathormone hormone; ESR, erythrocyte sedimentation rate; CRP, C-reactive protein; PTH, parathormone; TNF, tumor necrosis factor; IL, interleukin; PCDAI, pediatric Crohn’s disease activity index; PUCAI, pediatric ulcerative colitis activity.

Table 2 Disease Location, and Montreal Classification*

Disease Location for CD	Group I on MD (N = 50)	Group II (N = 50)
Upper GIT (n, %)L4	4(8)	5(10)
Ileal(n,%)L1	10(20)	11(22)
Ilioclonic(n,%)L3	9(18)	8(16)
Colonic (n, %)L2	3(6)	4(8)
Disease location for UC
Proctitis(n,%)E1	14(56)	14(18)
Left-sided colitis (n, %)E2	5(10)	4(8)
Extensive colitis (n, %)E3	5(20)	4(8)

Notes: Patients with fistula were excluded because they may need surgical interference at any time. *Montreal classification: L1-L4 for CD; E1-E3 for UC.

Table 3 Clinical Variables of Studied Patients

Presenting Symptoms	CD (n= 54)	UC (n=46)
GENERAL
Weight loss	42	37
Fever	16	4
Anorexia	18	5
Growth retardation	39	8
Lethargy	12	9
GASTROINTESTINAL
Abdominal pain	48	40
Diarrhea	35	42
Rectal bleeding	16	34
Nusea/vomiting	6	1
Constipation	2	1
Perianal disease*	5	0
Mouth ulcers	2	2

Notes: *Other than fistula. NB. Patient may present with more than one symptom.

Table 4 Growth Parameters, Serum Calcium, Vit D, PTH Triglycerides, Cholesterol. Glucose and Hemoglobin at Start of Study vs at the End

	Group I (n=50)			Group II (n=50)			P G I vs G II At End of Study
	At Start	At End	p	At Start	At End	p
Weight(kg)	31.6±7.1	33.0 4.4	0.61	30.5±6.8	29.9± 7.1	0.74	0.39
Height(cm)	142.7±24.6	143.2±19.9	0.43	142.3±21.9	144.0±22.2	0.69	0.81
BMI	17.7±2.4	17.9 ±3.0	0.8	17.2±2.6	18.1± 3.5	0.79	0.66
SerumCa(mg/l)	9.5±1.8	9.3 ±1.7	0.77	9.4±1.7	9.5 ±1.2	0.88	0.52
PTH(pg/mL)	51.3±11.3	51.1±10.8	0.91	49.6±12	50.4±11.3	0.62	0.62
Vit D(ng/mL)	23.4±2.7	24.6± 2.2	0.84	24.5±3.2	24.8 ±2.9	0.85	0.77
Triglycerides(mg/dl)	121.7 ± 55.6	120.4± 54.7	0.77	110.9 ±48.4	112.1± 51.0	0.78	0.21
Cholesterol(mg/dl)	171.0 ± 38.6	168.3± 40.5	0.81	188.6 ±40.1	186.5± 39.9	0.44	0.13
Glucose(mg/dl)	89.2± 21.2	91.1 ±20.6	0.47	87.7± 8.7	88.3± 8.2	0.61	0.41
Hemoglobin(g/dl)	13.6 ±1.9	14.0± 2.1	0.29	14.1 ±1.9	14.1± 1.6	0.91	0.73

Abbreviations: BMI, body mass index; Ca, calcium; PTH, parathormone hormone; Vit d, vitamin D.

Table 5 Mean IBD Activity Index and Mean Inflammatory Measures for Patients During Study Period

Elements	Enrollment			2 Week			4 Week			8 Week			12 Week
	GI	GII	P	GI	GII	P	GI	GII	P	GI	GII	P	GI	GII	P
PCDAI	38.3±9.5	38.6±11.2	0.93	19.1±12.6	21.5±10.8	0.74	12.7±7.5	14.8±9.2	0.3	9.7±11.2	11.3±10.5	0.04*	6.4±8.1	10.8±7.4	0.02*
					19.2±11.1	0.82	12.3±9.7	15.2±8.0	0.55	8.3±4.7	10.6±5.4	0.2	7.6±11.2	9.2±7.5	0.04*
PUCAI	37.9±15.4	39.1±14.9	0.96	18.7± 8.8
CRP(N< 10 mg/L)	25.4±18.1	27.1±20.5	0.98	19.6±21.1	22.3±16.5	0.66	12.3±11.3	16.1±14.9	0.1	4.4±2.7	8.1±3.0	0.04*	3.1±0.9	5.8±3.5	0.01*
ESR(N 0–20 mm/h)	14.3±12.1	15.7±10.9	0.92	11.7±9.9	11.9±10.0	0.77	10.2±8.8	10.0±7.8	0.8	8.3±6.3	8.2±7.5	0.88	6.5±5.2	5.8±6.1	0.66
Albumin(N 3.5–5.5 g/dL)	4.2±0.9	4.1±0.88	0.91	4.2±0.88	4.2±0.91	0.83	4.3±0.78	4.2±0.77	0.69	4.4±0.45	4.3±0.7	0.77	4.3±0.68	4.4±0.37	0.82
Calprotectin(N< 50 µg/g)	622.4±411.5	645.8± 435.7	0.88				405.4±168.8	488.2±230.9	0.06				221.5±88.5	395.7±194.4	0.03*
TNF-α (pg/mL)	18.9±3.8	17.8±2.7	0.696				14.7±4.0	14.2±3.5	0.88				10.1±2.5	12.2±3.8	0.04*
IL-17 (pg/mL)	27.1±4.2	26.9±4.6	0.24				22.8±5.5	22.1±6.2	0.6				14.5±3.7	18.2±4.7	0.02*
IL-10 (pg/mL)	6.5±1.3	6.6±1.4	0.652				4.9±1.5	5.0±1.7	0.82				4.1±0.9	4.6±1.1	0.1
IL-12 (pg/mL)	122.3±18.7	118.1±13.4	0.961				98.2±21.1	99.3±18.8	0.56				77.2±14.5	84.4±16.2	0.02*
IL-23 (pg/mL)	60.7±9.6	58.9±7.7	0.591				51.4±12.2	54.4±10.2	0.66				38.8±11.5	44.6±12.1	0.03*

Note: P* significant ≤0.05.