跳至主要内容
临床试验/NCT06396728
NCT06396728尚未招募不适用

Use of GI BIOTICS 100B UFC to Improve Intestinal Health and Sports Performance in Older Adults

Universidad de Almeria2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
44
试验地点
2
主要终点
Intestinal permeability

研究概览

简要总结

Type of study: Clinical Trial.

Main objective: To study the effect of daily consumption of the probiotic (GI BIOTICS 100B UFC) on intestinal inflammatory markers, intestinal microbiota, intestinal health, body composition and sports performance in older adults for 8 weeks.

Participant Population/Health Conditions: The study will involve 44 sedentary men with a body mass index > 25 kg/m2 and aged between 60 and 75 years.

Participants Will:

Be randomised into one of two groups: consumption of a placebo capsule (comparison group) and consumption of GI BIOTICS 100B UFC daily for a period of 8 weeks (experimental group). Provide feces and blood samples before and after the 8-week intervention. Undergo analysis of these samples using advanced techniques to understand the effect of the consumption of the probiotic. Undergo a submaximal stress test and muscle strength will be measured using a handgrip dynamometer.

详细描述

Intestinal health is essential for the general well-being of the body given the great diversity of microorganisms known as intestinal microbiota that the intestine houses. These microorganisms play a crucial role in digestion, nutrient absorption, metabolism and regulation of the immune system. However, various factors such as an unbalanced diet, stress and the use of antibiotics or other medications can alter the balance of the microbiota and lead to intestinal health problems, as occurs in those over 60 years of age. In this context, the use of probiotics has gained recognition as an effective strategy to improve intestinal health. Probiotics involve inoculating the intestine with live microorganisms that, when consumed in adequate amounts, provide health benefits. These beneficial bacteria for our body can colonize the intestine, restore the balance of the microbiota and promote an environment conducive to the proper functioning of the digestive system. Probiotics have shown evidence of improving gut health by strengthening the intestinal barrier, reducing intestinal permeability, and decreasing inflammation. In addition, they can improve the digestion of certain foods, produce beneficial vitamins and metabolites, and compete with harmful bacteria to occupy space in the intestine. Recently, it has been shown that specific bacterial species in the intestine could improve exercise capacity in athletes. In this line of thinking, novel and unpublished data from our laboratory unequivocally demonstrate that specific bacterial species can improve exercise capacity in mice through the gut-muscle axis as the main underlying mechanism. That being said, we hypothesize that daily consumption of the probiotic GI BIOTICS 100B UFC, designed by HSN, will reduce intestinal inflammation by improving gut microbiota composition and gut health. Furthermore, this improvement in the intestinal microbiota will reduce the percentage of body fat, improving the ability to run to exhaustion and force generation in older adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Single (Investigator)

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 60-75 years of age men. BMI >25 kg/m
  • Be willing to be randomized to either of these 2 groups. Must be sedentary (i.e., do not exercise or go to the gym).
  • Must be willing to adhere to all study procedures, including attendance at all study visits.
  • Must be willing to have biological samples stored for future research.
  • Having self-defined digestive problems (poor digestions, constipation, bloating in response to food, refluxes, heartburn)

排除标准

  • Diabetes Mellitus
  • High Blood Pressure
  • Being intolerant to lactose, fructose or sorbitol
  • Having consumed probiotics or antibiotics in the last 3 weeks
  • Be a regular smoker

结局指标

主要结局

Intestinal permeability

时间窗: 1 year

LPS and Zonulin will be quantified in feces before and after the intervention

Gut microbiota

时间窗: 1 year

In feces samples, 16S ribosomal RNA sequencing will be performed to quantify the composition of the intestinal microbiota.

次要结局

  • Body composition(1 year)
  • Blood samples(1 year)
  • Submaximal physical effort test(1 year)
  • Muscle strength(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Borja Martínez Tellez

Principal Investigator

Universidad de Almeria

研究点 (2)

Loading locations...

相似试验