Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396728
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-25
Brief Title:
Use of GI BIOTICS 100B UFC to Improve Intestinal Health in Older Adults
Sponsor:
Universidad de Almeria
Organization:
Universidad de Almeria
Study Overview
Official Title:
Use of GI BIOTICS 100B UFC to Improve Intestinal Health and Sports Performance in Older Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GIBIOTICS
Brief Summary:
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 PopulationHealth Conditions The study will involve 44 sedentary men with a body mass index 25 kgm2 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
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 PopulationHealth Conditions The study will involve 44 sedentary men with a body mass index 25 kgm2 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None