Assessment of the Effects of Synbiotic on Gut Microbiota Composition in Scholars With Overweight
Elaboration and Assessment of the Effects of Synbiotic on Gut Microbiota Composition of Scholars With Overweight
1 other identifier
interventional
37
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2017
CompletedFirst Submitted
Initial submission to the registry
June 9, 2022
CompletedFirst Posted
Study publicly available on registry
June 21, 2022
CompletedJune 21, 2022
June 1, 2022
2 months
June 9, 2022
June 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Gut bacteria associated with changes of the intervention group
Comparison of the log2ratio of the genera and the abundance of amplicon sequence variants across the different treatments.
Abundance of microbes and relative number of taxa in samples through study completion, 6 weeks intervention of each group
Effect of probiotic and synbiotic products intervention on the BMI z-score
Assesment of BMI-Z score changes
Comparison of BMI-Z score through study completion, 6 weeks intervention of each group.
Effect of probiotic and synbiotic products intervention on the fat percentage
Assesment of fat percentage changes
Comparison of fat percentage through study completion, 6 weeks intervention of each group.
Effect of probiotic and synbiotic products intervention on waist and neck circunference
Assesment of waist and neck circunference changes
Comparison of waist and neck circunference through study completion, 6 weeks intervention of each group.
Effect of probiotic and synbiotic products intervention on glucose, triglycerides and cholesterol serum levels
Assesment of glucose, triglycerides and cholesterol serum levels changes
Comparison of glucose, triglycerides and cholesterol serum levels through study completion, 6 weeks intervention of each group.
Secondary Outcomes (1)
Effect of probiotic and synbiotic products intervention on Free Fatty Acid Receptors (FFAR) 2 and 3 levels
Comparison of mRNA levels of FFAR2 and FFAR3 through study completion, 6 weeks intervention of each group.
Study Arms (3)
Lactobacillus casei (Probiotic)
EXPERIMENTALConsist in a commercial fermented milk food (Soful LT), which Lactobacillus casei was used as a primary base (probiotic product)
L. casei strain Shirota plus inulin (Syn-Inulin)
EXPERIMENTALConsist in a commercial fermented milk food (Soful LT), which Lactobacillus casei was used as a primary base (probiotic product) and enriched with 3g of inulin.
L. casei strain Shirota plus fructans from A. salmiana (Syn-A. salmiana)
EXPERIMENTALConsist in a commercial fermented milk food (Soful LT), which Lactobacillus casei was used as a primary base (probiotic product) and enriched with 3g of fructans from A. salmiana.
Interventions
Probiotic product were made in a Class II biosafety cabinet. Fifteen milliliters of the fermented milk food wich contains LcS were taken with a sterile syringe, and, at a subsequent time, 15 mL of sterile water were added to the probiotic product.
The Syn-inulin products were made in a Class II biosafety cabinet. Fifteen milliliters of the fermented milk food wich contains LcS were taken with a sterile syringe, and, at a subsequent time, 3 g of inulin (BENEO GmbH) were diluted in 15 mL of sterile water and added to Syn-inulin products.
The Syn-A. salmiana products were made in a Class II biosafety cabinet. Fifteen milliliters of the fermented milk food wich contains LcS were taken with a sterile syringe, and, at a subsequent time, 3 g of fructans from A. salmiana were diluted in 15 mL of sterile water and added to Syn-A.salmiana products.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí
San Luis Potosí City, 78210, Mexico
Related Publications (8)
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.
PMID: 21521545BACKGROUNDFernandes 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.
PMID: 27771020BACKGROUNDRegalado-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.
PMID: 32455193BACKGROUNDLarsen 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.
PMID: 23510724BACKGROUNDMartinez-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.
BACKGROUNDNagata 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.
PMID: 28618860BACKGROUNDSafavi 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.
PMID: 23477506BACKGROUNDVega-Cardenas M, Martinez-Gutierrez F, Lara-Ramirez EE, Reynaga-Hernandez E, Yanez-Estrada L, Ratering S, Schnell S, Godinez-Hernandez CI, Vargas-Morales JM, Portales-Perez DP. Agave fructans enhance the effects of fermented milk products on obesity biomarkers: a randomised trial. Benef Microbes. 2023 Apr 18;14(2):153-164. doi: 10.3920/BM2022.0078. Epub 2023 Mar 1.
PMID: 36856122DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diana Patricia Portales-Pérez, phD
Universidad Autonoma de San Luis Potosí
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The enrolled children were randomized to the three groups in a 1:1:1 ratio stratified by age at the time of study enrolment. The study's investigators and clinical staff were blinded until the final database. Only appointed staff had access to the randomization list to perform labeling of the study products.
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Professor
Study Record Dates
First Submitted
June 9, 2022
First Posted
June 21, 2022
Study Start
July 21, 2017
Primary Completion
October 2, 2017
Study Completion
October 9, 2017
Last Updated
June 21, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share