Clinical Trial of Lactiplantibacillus Plantarum Dad-13 on Gut Microbiota Profile and Performance in Adolescent Athletes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- gut microbiota profile
研究概览
简要总结
The aim of this research is to analyze the effect of a Lactiplantibacillus plantarum Dad-13 supplementation on the gut microbiota profile and performance of adolescent athletes.
详细描述
An athlete's physical performance can be influenced by the balance of gut microbiota in the digestive tract. Research shows that as many as 96% of ultramarathon participants (161 km) experience several digestive symptoms such as belching, nausea, vomiting and stress with a failure to reach 35.6% in completing the race. The diversity of an athlete's gut microbiota is higher than that of a normal person. This study is a true experimental study with a double-blind, pre- and posttest randomized controlled trial with a total of 30 athletes as respondents. There are two treatments: the first group will be given 1 gram of capsule preparation containing the probiotic Lactiplantibacillus plantarum Dad-13 given twice/day and the control group given a placebo capsule twice/day. The probiotic intervention was given at breakfast and dinner for 8 weeks. Measurement of the microbiota profile comes from fecal samples to further measure digestive tract health, SCFA levels, and calprotectin concentrations. Analysis of alpha diversity and beta diversity using Microbiome Analyst software. Physical performance was measured using VO2max using a direct laboratory method, namely the COSMED K5 instrument, before and after the intervention in kg/mL. Food intake was measured using a 24-hour food recall method and physical activity using an activity recall method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Residing in the BPPLOP dormitory of Central Java Province;
- •Having a normal body mass index;
- •Being an athlete in an endurance sport;
- •Having no growth disorders
排除标准
- •Injury, any health contraindication or failure to perform exercise procedures;
- •Gastrointestinal infections, diseases, disorders;
- •Past history of gastrointestinal surgery;
- •Failure to follow the study protocol;
- •Declared general feeling of being unwell
研究组 & 干预措施
Control group
placebo capsule twice/day
干预措施: Probiotic Lactiplantibacillus plantarum Dad-13 (Dietary Supplement)
结局指标
主要结局
gut microbiota profile
时间窗: From pre treatment and the end of treatment at 8 weeks
Gut microbiota profiles were measured from fecal samples, then isolated using 16S rDNA sequencing. Fecal samples were collected in the morning. Results: alfa and beta diversity
Short chain fatty acid profile
时间窗: pre treatment and end of treatment at 8 weeks
The total level or amount of short chain fatty acid metabolites produced from the fermentation process in the intestine obtained from feces. Results: Total amount of SCFA, acetic acid, propionic acid, butyric acid
Physical Performance
时间窗: pre treatment and the end of treatment at 8 weeks
The physical performance measurement used was VO2max. The VO2max measurement method used a direct laboratory method with COSMED K5 before and after the intervention, with units of kg/mL.
次要结局
- Fecal calprotectin concentration(pre treatment and the end of treatment at 8 weeks)
研究者
Natalia Desy Putriningtyas
PhD student and as a Dietisien
Gadjah Mada University
