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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
37
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.
Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí
San Luis Potosí City, Mexico
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Assessment of mRNA levels of FFAR2 and FFAR3 in the peripheral blood mononuclear cells changes
Time frame: Comparison of mRNA levels of FFAR2 and FFAR3 through study completion, 6 weeks intervention of each group.
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