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

Sponsor

Universidad Autonoma de San Luis Potosí (Other)

Overall Status

Completed

CT.gov ID

NCT05423015

Collaborator

(none)

Enrollment

Location

Arms

2.6

Actual Duration (Months)

14.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Childhood Obesity Childhood Overweight	Dietary Supplement: Lactobacillus casei strain Shirota Dietary Supplement: Lactobacillus casei strain Shirota plus inulin Dietary Supplement: Lactobacillus casei strain Shirota plus fructans from A. salmiana	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Randomised, double blind controlled protocol in children with overweight or obesity aged 6-11 yearsRandomised, double blind controlled protocol in children with overweight or obesity aged 6-11 years

Masking:

Double (Participant, 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.

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 21, 2017

Actual Primary Completion Date :

Oct 2, 2017

Actual Study Completion Date :

Oct 9, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lactobacillus casei (Probiotic) Consist in a commercial fermented milk food (Soful LT), which Lactobacillus casei was used as a primary base (probiotic product)	Dietary Supplement: Lactobacillus 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. Other Names: L. casei Shirota LcS Probiotic product
Experimental: L. casei strain Shirota plus inulin (Syn-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.	Dietary Supplement: Lactobacillus 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. Other Names: LcS + inulin Synbiotic product Syn-inulin
Experimental: L. casei strain Shirota plus fructans from A. salmiana (Syn-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.	Dietary Supplement: Lactobacillus 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. Other Names: Lactobacillus casei strain Shirota plus A.salmiana LcS + fructans LcS + A. salmiana Synbiotic product Syn- A. salmiana

Arm

Intervention/Treatment

Experimental: Lactobacillus casei (Probiotic)

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

Dietary Supplement: Lactobacillus 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.

Other Names:

L. casei Shirota

LcS

Probiotic product

Experimental: L. casei strain Shirota plus inulin (Syn-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.

Dietary Supplement: Lactobacillus 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.

Other Names:

LcS + inulin

Synbiotic product

Syn-inulin

Experimental: L. casei strain Shirota plus fructans from A. salmiana (Syn-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.

Dietary Supplement: Lactobacillus 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.

Other Names:

Lactobacillus casei strain Shirota plus A.salmiana

LcS + fructans

LcS + A. salmiana

Synbiotic product

Syn- A. salmiana

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.