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临床试验/NCT07476573
NCT07476573尚未招募不适用

Clinical Trial of Lactiplantibacillus Plantarum Dad-13 on Gut Microbiota Profile and Performance in Adolescent Athletes

Gadjah Mada University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年4月13日最近更新:
干预措施

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

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

Experimental

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

发起方
Gadjah Mada University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Natalia Desy Putriningtyas

PhD student and as a Dietisien

Gadjah Mada University

研究点 (1)

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