A randomized triple-masked controlled trial on the effects of synbiotics on inflammation markers in overweight children

Kelishadi, Roya; Farajian, Sanam; Safavi, Morteza; Mirlohi, Maryam; Hashemipour, Mahin

doi:10.1016/j.jped.2013.07.003

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Original Articles • J. Pediatr. (Rio J.) 90 (02) • Mar-Apr 2014 • https://doi.org/10.1016/j.jped.2013.07.003 copy

A randomized triple-masked controlled trial on the effects of synbiotics on inflammation markers in overweight children^☆ ☆ Please cite this article as: Kelishadi R, Farajian S, Safavi M, Mirlohi M, Hashemipour M. A randomized triple-masked controlled trial on the effects of synbiotics on inflammation markers in overweight children. J Pediatr (Rio J). 2014;90:161-8.

Authorship SCIMAGO INSTITUTIONS RANKINGS

OBJECTIVE:

the low degree of inflammation in obesity contributes to systemic metabolic dysfunction. Recent experimental studies proposed some effects of alteration in gut microbiota on inflammatory factors. This study aimed to assess the anti-inflammatory effects of a synbiotic supplement on inflammation markers in overweight and obese children and adolescents.

METHODS:

this randomized triple-masked controlled trial was conducted among 70 participants aged 6 to 18 years, with a body mass index (BMI) equal or higher than the 85th percentile. They were randomly assigned into two groups of equal number to receive synbiotic or placebo for eight weeks.

RESULTS:

fifty-six of 70 participants (80%) completed the study. Compared with the placebo group, the synbiotic group had significant decrease in mean values of tumor necrosis-α and interleukin-6, with significant increase in adiponectin; these changes were no longer significant after adjustment for BMI. There was no significant change in the mean values of high-sensitive C-reactive protein.

CONCLUSION:

the present findings suggest the positive influence of synbiotic supplementation on inflammation factors, which are dependent to its effect on weight reduction in overweight and obese children.

Synbiotic; Children and adolescents; Obesity; Inflammation; Trial

Variables	Stage	Synbiotic group	Placebo group	p ^b
n		29	27
Age (years)		10.75 ± 2.49	10.09 ± 1.93	0.61
Weight (kg)	Before	53.29 ± 3.52	46.84 ± 1.97	0.12
	After	52.90 ± 3.43	48.84 ± 2.34	0.34
	Difference	0.39 ± 0.25	-2.00 ± 1.23	0.06
	p ^c	< 0.0001	< 0.0001
Body mass index Z-score	Before	1.79 ± 0.50	1.6 ± 0.39	0.34
	After	1.69 ± 0.51	1.65 ± 0.36	0.74
	Difference	0.09 ± 0.07	0.02 ± 0.1	0.002
	p ^c	< 0.0001	0.38
Waist circumference (cm)	Before	84.22 ± 15.36	76.53 ± 9.92	0.32
	After	82.89 ± 15.18	76.85 ± 9.82	0.08
	Difference	-1.32 ± 0.66	0.31 ± 0.88	< 0.0001
	p ^c	< 0.0001	0.73
Waist- to- hipratio	Before	0.36 ± 0.09	0.41 ± 0.42	0.53
	After	0.35 ± 0.09	0.34 ± 0.06	0.49
	Difference	0.008 ± 0.009	0.073 ± 0.44	0.43
	p ^c	< 0.0001	0.40

Stage	Synbiotic group (n = 29)	Placebo group (n = 27)	p-value
Physical activity
Before	2.31 ± 0.47	2.44 ± 0.50	0.30
After	2.41 ± 0.51	2.44 ± 0.57	0.83
Difference	-0.10 ± 0.61	0.00 ± 0.67	0.55
p ^a	0.37	1.00
Energy (kcal)
Before	1,508 ± 44.69	1,454 ± 44.69	0.35
After	1,516 ± 33.83	1,433 ± 35.06	0.09
Difference	-7.90 ± 34.36	20.90 ± 28.61	0.52
p ^a	0.82	0.41
Protein (g)
Before	59.40 ± 2.48	64.20 ± 2.93	0.21
After	55.22 ± 1.88	58.14 ± 1.96	0.28
Difference	8.87 ± 4.72	6.05 ± 3.50	0.66
p ^a	0.12	0.09
Carbohydrate (g)
Before	187.05 ± 6.39	179.24 ± 6.91	0.41
After	189.68 ± 6.94	183.05 ± 7.31	0.51
Difference	-2.63 ± 6.07	-3.80 ± 7.12	0.90
p ^a	0.66	0.59
Total fat (g)
Before	65.08 ± 4.54	58.05 ± 3.76	0.24
After	65.39 ± 8.83	61.62 ± 1.21	0.07
Difference	-0.31 ± 5.06	-3.57 ± 3.55	0.60
p ^a	0.95	0.32
Saturated fat (g)
Before	17.93 ± 0.80	17.14 ± 0.74	0.47
After	18.61 ± 0.90	17.54 ± 0.71	0.37
Difference	-0.66 ± 1.03	-0.43 ± 0.81	0.85
p ^a	0.51	0.59
Mono unsaturated fat (g)
Before	16.92 ± 0.78	17.02 ± 0.87	0.93
After	17.97 ± 0.47	16.79 ± 0.59	0.12
Difference	-1.05 ± 0.83	0.23 ± 0.84	0.28
p ^a	0.21	0.78
Poly unsaturated fat (g)
Before	13.71 ± 0.69	13.15 ± 0.69	0.53
After	14.23 ± 0.45	13.49 ± 0.39	0.22
Difference	-0.52 ± 0.49	-0.33 ± 0.33	0.79
p ^a	0.30	0.49
cholesterol (g)
Before	257.44 ± 13.58	233.11 ± 8.12	0.13
After	257.26 ± 9.08	241.72 ± 10.52	0.26
Difference	0.17 ± 14.45	-8.60 ± 9.64	0.61
p ^a	0.99	0.38
Dietary fiber (g)
Before	12.21 ± 0.84	14.00 ± 0.72	0.11
After	11.14 ± 0.70	12.37 ± 0.51	0.16
Difference	1.07 ± 0.79	1.62 ± 0.96	0.66
p ^a	0.18	0.10

Type of Bacteria	Stage	Synbiotic group Mean ± SD	Placebo group Mean ± SD
Genus Lactobacillus	Baseline	46990603 ± 68305170	35554312 ± 52377526
	Day 15	9.8849404 ± 56632828	20521047 ± 14446100
	Day 60	104007006 ± 95400927	28320225 ± 28512981
p-value	0.029	0.69
Bifidobacteria	Baseline	483104.1 ± 1083977.2	1856453.3 ± 5486345.3
	Day 15	92521.0 ± 117058.9	35964.9 ± 26621.0
	Day 60	1965978.9 ± 2699014.4	337154.7 ± 610843.9
p-value	0.06	0.39

Variables	Stage	Synbiotic group n = 28 mean ± SE	Placebo group n = 27 mean ± SE	p ^a	Time × group^b	Time^c	Group^d
Hs-CRP	Before	2.05 ± 0.92	1.66 ± 0.96	0.42	0.61	0.141	0.92
	After	1.03 ± 0.14	1.75 ± 0.13	0.17
	Difference	-0.7 ±0.07	0.09 ± 0.05	0.06
p ^e		0.02	0.75
TNFa	Before	123.14 ± 9.63	94.15 ± 9.44	0.06	0.008	0.92	0.152
	After	113.25 ± 3.30	103.40 ± 3.26	0.48
	Difference	-9.89 ± 0.55	9.25 ± 0.68	p < 0.0001
p ^e		0.02	0.10
Adjusted ^f		1.02 ± 0.08	1.14 ± 0.09	0.105
IL-6	Before	130.07 ± 4.73	121.30 ± 4.50	0.37	0.118	0.06	0.72
	After	119.25 ± 3.62	120.33 ± 4.66	0.92
	Difference	-10.82 ± 0.64	-0.96 ± 0.82	P<0.0001
p ^e		0.04	0.76
Adjusted ^f		1.13 ± 0.05	1.26 ± 0.06	0.06
Adiponectin	Before	261.61 ± 3.96	283.67 ± 3.17	0.34	0.05	0.139	0.82
	After	289.64 ± 11.59	279.07 ± 11.83	0.70
	Difference	28.03 ± 1.39	-3.69 ± 1.97	p < 0.0001
p ^e		P < 0.0001	0.79
Adjusted ^f		2.94 ± 0.90	2.74 ± 0.14	0.25

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[1] * Corresponding author. E-mail: farajian.sanam@gmail.com ^{S. Farajian}