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

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

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).

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.

Consist in a commercial fermented milk food (Soful LT), which Lactobacillus casei was used as a primary base (probiotic product)

Consist 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.

Consist 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.

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.

Lactobacillus casei strain Shirota plus A.salmiana, LcS + fructans, LcS + A. salmiana, Synbiotic product, Syn- A. salmiana

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.

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

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

Comparison of glucose, triglycerides and cholesterol serum levels through study completion, 6 weeks intervention of each group.

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.

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.

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