Childhood Obesity, Childhood Overweight
Conditions
Keywords
Microbiota, Probiotic, Fermented milk product, Synbiotic
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).
Interventions
DIETARY_SUPPLEMENTLactobacillus casei strain Shirota
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.
DIETARY_SUPPLEMENTLactobacillus casei strain Shirota plus inulin
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.
DIETARY_SUPPLEMENTLactobacillus casei strain Shirota plus fructans from 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.
Sponsors
Universidad Autonoma de San Luis Potosí
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
Randomised, double blind controlled protocol in children with overweight or obesity aged 6-11 years
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 the fat percentage | Comparison of fat percentage through study completion, 6 weeks intervention of each group. | Assesment of fat percentage 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Mexico
Outcome results
None listed