Elaboration and Assessment of the Effects of Synbiotic on Gut Microbiota Composition of Scholars With Overweight
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Effect of probiotic and synbiotic products intervention on the fat percentage
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Effect of probiotic and synbiotic products intervention on the fat percentage
时间窗: Comparison of fat percentage through study completion, 6 weeks intervention of each group.
Assesment of fat percentage changes
Gut bacteria associated with changes of the intervention group
时间窗: 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
时间窗: 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 waist and neck circunference
时间窗: 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
时间窗: 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
次要结局
- 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.)
研究者
Diana Patricia Portales-Pérez
Research Professor
Universidad Autonoma de San Luis Potosí