Assessment of the Effects of Synbiotic on Gut Microbiota Composition in Scholars With Overweight

Not Applicable

Completed

• Conditions: Childhood Overweight; Childhood Obesity
• Interventions: Dietary Supplement: Lactobacillus casei strain Shirota plus fructans from A. salmiana; Dietary Supplement: Lactobacillus casei strain Shirota; Dietary Supplement: Lactobacillus casei strain Shirota plus inulin

• Registration Number: NCT05423015
• Lead Sponsor: Universidad Autonoma de San Luis Potosí

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).

Study Timeline

• Study Start: 2017-07-21
• Primary Completion: 2017-10-02
• Study Completion: 2017-10-09
• Status Verified: 2022-06
• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-14
• Last Update Submitted: 2022-06-14
• Study First Posted: 2022-06-21
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
L. casei strain Shirota plus fructans from A. salmiana (Syn-A. salmiana)	Lactobacillus casei strain Shirota plus fructans from A. salmiana	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.
Lactobacillus casei (Probiotic)	Lactobacillus casei strain Shirota	Consist 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)	Lactobacillus casei strain Shirota plus 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 inulin.

Primary Outcome Measures

Name	Time	Method
Effect of probiotic and synbiotic products intervention on the fat percentage	Comparison of fat percentage through study completion, 6 weeks intervention of each group.	Assesment of fat percentage changes
Gut bacteria associated with changes of the intervention group	Abundance of microbes and relative number of taxa in samples through study completion, 6 weeks intervention of each group	Comparison of the log2ratio of the genera and the abundance of amplicon sequence variants across the different treatments.
Effect of probiotic and synbiotic products intervention on the BMI z-score	Comparison of BMI-Z score through study completion, 6 weeks intervention of each group.	Assesment of BMI-Z score changes
Effect of probiotic and synbiotic products intervention on waist and neck circunference	Comparison of waist and neck circunference through study completion, 6 weeks intervention of each group.	Assesment of waist and neck circunference changes
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.	Assesment of glucose, triglycerides and cholesterol serum levels changes

Secondary Outcome Measures

Name	Time	Method
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.	Assessment of mRNA levels of FFAR2 and FFAR3 in the peripheral blood mononuclear cells changes

Trial Locations

Locations (1)

Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí; 🇲🇽 San Luis Potosí, Mexico