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Completed

NCT Number: NCT05423015

Assessment of the Effects of Synbiotic on Gut Microbiota Composition in 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

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Key information

Conditions

Childhood Obesity Body Weight Childhood Overweight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí

San Luis Potosí City, 78210, Mexico

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus casei strain Shirota

Dietary Supplement

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

Lactobacillus casei strain Shirota plus inulin

Dietary Supplement

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

Lactobacillus casei strain Shirota plus fructans from A. salmiana

Dietary Supplement

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

Primary outcomes

  1. Gut bacteria associated with changes of the intervention group

    Time frame: 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.

  2. Effect of probiotic and synbiotic products intervention on the BMI z-score

    Time frame: Comparison of BMI-Z score through study completion, 6 weeks intervention of each group.

    Assesment of BMI-Z score changes

  3. Effect of probiotic and synbiotic products intervention on the fat percentage

    Time frame: Comparison of fat percentage through study completion, 6 weeks intervention of each group.

    Assesment of fat percentage changes

  4. Effect of probiotic and synbiotic products intervention on waist and neck circunference

    Time frame: Comparison of waist and neck circunference through study completion, 6 weeks intervention of each group.

    Assesment of waist and neck circunference changes

  5. Effect of probiotic and synbiotic products intervention on glucose, triglycerides and cholesterol serum levels

    Time frame: 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 outcomes

  1. Effect of probiotic and synbiotic products intervention on Free Fatty Acid Receptors (FFAR) 2 and 3 levels

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de San Luis Potosí

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 21, 2022
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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