Clinical trial NCT05423015: Assessment of the Effects of Synbiotic on Gut Microbiota Composition in Scholars With Overweight
Official title: Elaboration and Assessment of the Effects of Synbiotic on Gut Microbiota Composition of Scholars With Overweight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Childhood Overweight
Keywords: Microbiota
Probiotic
Fermented milk product
Synbiotic
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 37
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomised, double blind controlled protocol in children with overweight or obesity aged 6-11 years
Primary purpose: BASIC_SCIENCE

Brief summary: This study was a randomized, double-blind controlled protocol in children overweight aged 6-11 years. This study aimed to evaluate the effect of consuming fermented milk products containing Lactobacillus casei strain Shirota (LcS), as a probiotic enriched with prebiotic fructans from A. salmiana or inulin-like standard commercial prebiotic to improve the gut microbiota modulation. After providing detailed information, written informed consent was obtained from parents and written and oral assent from participants before the initial test day. Children were eligible for inclusion in the trial if they were overweight according to the World Health Organization (≥85th body mass index (BMI) percentile for overweight). The trial took place in three full-time elementary schools in San Luis Potosí, México, and the screening of the prospective participants took place up to 1 week prior to the randomization. Children were evaluated over a 6-week intervention period receiving different fermented milk products

Detailed description: Male and female children between the ages of 6- 10 years old were recruited from three schools located in San Luis Potosi, Mexico. According to the World Health Organization, children with overweight were requested to participate and were voluntarily recruited.

After providing detailed information, written informed consent was obtained from parents and written and oral assent from participants before the initial test day. The trial investigated the effect of daily intake of fermented milk products containing Lactobacillus casei strain Shirota (LcS), LcS plus inulin (LcS+inulin), and LcS plus fructans from A. salmiana (LcS+fructans) on gut microbiota composition. The trial protocol was conducted according to the principles of the Declaration of Helsinki. It was approved by the Ethical Committee on Human Experimentation of the State Committee of Health Education and Research of the Health Secretary in San Luis Potosi (register number SLP/012-2017).

Eligibility criteria: Inclusion Criteria:

* Children were overweight or obese, according to the World Health Organization (≥85th body mass index (BMI) percentile for overweight, and ≥95th BMI percentile for obesity).

Exclusion Criteria:

* Any known infections, systemic diseases or metabolic diseases, and use of any prescribed medications or antibiotics in the one month before randomization and during the trial.

Primary outcomes:
measure: Gut bacteria associated with changes of the intervention group
timeFrame: Abundance of microbes and relative number of taxa in samples through study completion, 6 weeks intervention of each group
measure: Effect of probiotic and synbiotic products intervention on the BMI z-score
timeFrame: Comparison of BMI-Z score through study completion, 6 weeks intervention of each group.
measure: Effect of probiotic and synbiotic products intervention on the fat percentage
timeFrame: Comparison of fat percentage through study completion, 6 weeks intervention of each group.
measure: Effect of probiotic and synbiotic products intervention on waist and neck circunference
timeFrame: Comparison of waist and neck circunference through study completion, 6 weeks intervention of each group.
measure: Effect of probiotic and synbiotic products intervention on glucose, triglycerides and cholesterol serum levels
timeFrame: Comparison of glucose, triglycerides and cholesterol serum levels through study completion, 6 weeks intervention of each group.
Secondary outcomes:
measure: Effect of probiotic and synbiotic products intervention on Free Fatty Acid Receptors (FFAR) 2 and 3 levels
timeFrame: Comparison of mRNA levels of FFAR2 and FFAR3 through study completion, 6 weeks intervention of each group.
Other outcomes:
Locations:
city: San Luis Potosí
country: Mexico
facility: Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí
Study officials:
affiliation: Universidad Autónoma de San Luis Potosí
name: Diana Patricia Portales-Pérez, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nagata S, Asahara T, Ohta T, Yamada T, Kondo S, Bian L, Wang C, Yamashiro Y, Nomoto K. Effect of the continuous intake of probiotic-fermented milk containing Lactobacillus casei strain Shirota on fever in a mass outbreak of norovirus gastroenteritis and the faecal microflora in a health service facility for the aged. Br J Nutr. 2011 Aug;106(4):549-56. doi: 10.1017/S000711451100064X. Epub 2011 Apr 27.
citation: Fernandes R, do Rosario VA, Mocellin MC, Kuntz MGF, Trindade EBSM. Effects of inulin-type fructans, galacto-oligosaccharides and related synbiotics on inflammatory markers in adult patients with overweight or obesity: A systematic review. Clin Nutr. 2017 Oct;36(5):1197-1206. doi: 10.1016/j.clnu.2016.10.003. Epub 2016 Oct 8.
citation: Regalado-Renteria E, Aguirre-Rivera JR, Godinez-Hernandez CI, Garcia-Lopez JC, Oros-Ovalle AC, Martinez-Gutierrez F, Martinez-Martinez M, Ratering S, Schnell S, Ruiz-Cabrera MA, Juarez-Flores BI. Effects of Agave Fructans, Inulin, and Starch on Metabolic Syndrome Aspects in Healthy Wistar Rats. ACS Omega. 2020 May 6;5(19):10740-10749. doi: 10.1021/acsomega.0c00272. eCollection 2020 May 19.
citation: Larsen N, Vogensen FK, Gobel RJ, Michaelsen KF, Forssten SD, Lahtinen SJ, Jakobsen M. Effect of Lactobacillus salivarius Ls-33 on fecal microbiota in obese adolescents. Clin Nutr. 2013 Dec;32(6):935-40. doi: 10.1016/j.clnu.2013.02.007. Epub 2013 Mar 4.
citation: Martinez-Gutierrez, F., Ratering, S., Juárez-Flores, B., et al. Potential use of Agave salmiana as a prebiotic that stimulates the growth of probiotic bacteria. Lwt, 2017; 84:151-159.
citation: Nagata S, Chiba Y, Wang C, Yamashiro Y. The effects of the Lactobacillus casei strain on obesity in children: a pilot study. Benef Microbes. 2017 Aug 24;8(4):535-543. doi: 10.3920/BM2016.0170. Epub 2017 Jun 16.
citation: Safavi M, Farajian S, Kelishadi R, Mirlohi M, Hashemipour M. The effects of synbiotic supplementation on some cardio-metabolic risk factors in overweight and obese children: a randomized triple-masked controlled trial. Int J Food Sci Nutr. 2013 Sep;64(6):687-93. doi: 10.3109/09637486.2013.775224. Epub 2013 Mar 12.