Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06396728

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

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
44 (estimated)
Sponsor
Universidad de Almeria · Academic / Other
Sex
Male
Age
60 Years – 75 Years
Healthy volunteers
Not accepted

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 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.

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTGI BIOTICS 100B UFCConsumption of GI BIOTICS 100B UFC.
DIETARY_SUPPLEMENTPlacebo ConsumptionConsumption of a placebo capsule.

Timeline

Start date
2024-06-01
Primary completion
2024-11-30
Completion
2025-03-01
First posted
2024-05-02
Last updated
2024-05-02

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT06396728. Inclusion in this directory is not an endorsement.