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

Gut Microbiota Clinical Trial

— GIBIOTICS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06396728
• Other study ID #: TRFE-SI-2023/006
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Universidad de Almeria
• Contact: Borja Martinez Tellez, PhD
• Phone: +34 950215334
• Email: borjammt[@]ual.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: March 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• 60-75 years of age men. BMI >25 kg/m2. 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Digestive System
• Gut Health
• Gut Microbiota
• Inflammation
• Intestinal Inflammation
• Strength

Intervention

Dietary Supplement:
• GI BIOTICS 100B UFC
Consumption of GI BIOTICS 100B UFC.
• Placebo Consumption
Consumption of a placebo capsule.

Locations

Country	Name	City	State
Spain	Universidad de Almería	Almería

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal permeability	LPS and Zonulin will be quantified in feces before and after the intervention	1 year
Primary	Gut microbiota	In feces samples, 16S ribosomal RNA sequencing will be performed to quantify the composition of the intestinal microbiota.	1 year
Secondary	Body composition	The body composition of the participants will be measured using a state-of-the-art device.	1 year
Secondary	Blood samples	These samples will be centrifuged, and the serum and plasma will be aliquoted and stored at -80ºC for future analyses.	1 year
Secondary	Submaximal physical effort test	Sports performance will be evaluated through a submaximal physical effort test.	1 year
Secondary	Muscle strength	Muscle strength will be measured using a handgrip dynamometer.	1 year