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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus casei (Probiotic) | Experimental | Consist in a commercial fermented milk food (Soful LT), which Lactobacillus casei was used as a primary base (probiotic product) |
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| L. casei strain Shirota plus inulin (Syn-Inulin) | Experimental | 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. |
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| L. casei strain Shirota plus fructans from A. salmiana (Syn-A. salmiana) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 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 | 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 | Comparison of glucose, triglycerides and cholesterol serum levels through study completion, 6 weeks intervention of each group. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Comparison of mRNA levels of FFAR2 and FFAR3 through study completion, 6 weeks intervention of each group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana Patricia Portales-Pérez, phD | Universidad Autonoma de San Luis Potosí | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí | San Luis Potosí City | 78210 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21521545 | Background | Nagata S, Asahara T, Ohta T, Yamada T, Kondo S, Bian L, Wang C, Yamashiro Y, Nomoto K. Effect of the continuous intake of probiotic-fermented milk containing Lactobacillus casei strain Shirota on fever in a mass outbreak of norovirus gastroenteritis and the faecal microflora in a health service facility for the aged. Br J Nutr. 2011 Aug;106(4):549-56. doi: 10.1017/S000711451100064X. Epub 2011 Apr 27. | |
| 27771020 |
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Randomised, double blind controlled protocol in children with overweight or obesity aged 6-11 years
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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.
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| 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. |
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| 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. |
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| Background |
| Fernandes R, do Rosario VA, Mocellin MC, Kuntz MGF, Trindade EBSM. Effects of inulin-type fructans, galacto-oligosaccharides and related synbiotics on inflammatory markers in adult patients with overweight or obesity: A systematic review. Clin Nutr. 2017 Oct;36(5):1197-1206. doi: 10.1016/j.clnu.2016.10.003. Epub 2016 Oct 8. |
| 32455193 | Background | Regalado-Renteria E, Aguirre-Rivera JR, Godinez-Hernandez CI, Garcia-Lopez JC, Oros-Ovalle AC, Martinez-Gutierrez F, Martinez-Martinez M, Ratering S, Schnell S, Ruiz-Cabrera MA, Juarez-Flores BI. Effects of Agave Fructans, Inulin, and Starch on Metabolic Syndrome Aspects in Healthy Wistar Rats. ACS Omega. 2020 May 6;5(19):10740-10749. doi: 10.1021/acsomega.0c00272. eCollection 2020 May 19. |
| 23510724 | Background | Larsen N, Vogensen FK, Gobel RJ, Michaelsen KF, Forssten SD, Lahtinen SJ, Jakobsen M. Effect of Lactobacillus salivarius Ls-33 on fecal microbiota in obese adolescents. Clin Nutr. 2013 Dec;32(6):935-40. doi: 10.1016/j.clnu.2013.02.007. Epub 2013 Mar 4. |
| Background | Martinez-Gutierrez, F., Ratering, S., Juárez-Flores, B., et al. Potential use of Agave salmiana as a prebiotic that stimulates the growth of probiotic bacteria. Lwt, 2017; 84:151-159. |
| 28618860 | Background | Nagata S, Chiba Y, Wang C, Yamashiro Y. The effects of the Lactobacillus casei strain on obesity in children: a pilot study. Benef Microbes. 2017 Aug 24;8(4):535-543. doi: 10.3920/BM2016.0170. Epub 2017 Jun 16. |
| 23477506 | Background | Safavi M, Farajian S, Kelishadi R, Mirlohi M, Hashemipour M. The effects of synbiotic supplementation on some cardio-metabolic risk factors in overweight and obese children: a randomized triple-masked controlled trial. Int J Food Sci Nutr. 2013 Sep;64(6):687-93. doi: 10.3109/09637486.2013.775224. Epub 2013 Mar 12. |
| 36856122 | Derived | Vega-Cardenas M, Martinez-Gutierrez F, Lara-Ramirez EE, Reynaga-Hernandez E, Yanez-Estrada L, Ratering S, Schnell S, Godinez-Hernandez CI, Vargas-Morales JM, Portales-Perez DP. Agave fructans enhance the effects of fermented milk products on obesity biomarkers: a randomised trial. Benef Microbes. 2023 Apr 18;14(2):153-164. doi: 10.3920/BM2022.0078. Epub 2023 Mar 1. |
| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| D005630 | Fructans |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |
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