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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gut Microbiota; Strength; Gut Health; Intestinal Inflammation; Digestive System
• Intervention / Treatment: Dietary supplement: GI BIOTICS 100B UFC; Dietary supplement: Placebo Consumption

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 Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Borja Martinez Tellez, PhD; Phone Number: +34 +34 950215334; Email: borjammt@ual.es

Study Locations

• Spain
  • Almería, Spain, 04120
    • Universidad de Almeria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Consumption of GI BIOTICS 100B UFC; Participants will consume one GI BIOTICS 100B UFC capsule daily for a period of 8 weeks; n=22.	Dietary supplement: GI BIOTICS 100B UFC; Consumption of GI BIOTICS 100B UFC.
Placebo Comparator: Placebo Consumption; Participants will consume one placebo capsule daily for a period of 8 weeks; n=22.	Dietary supplement: Placebo Consumption; Consumption of a placebo capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal permeability	LPS and Zonulin will be quantified in feces before and after the intervention	1 year
Gut microbiota	In feces samples, 16S ribosomal RNA sequencing will be performed to quantify the composition of the intestinal microbiota.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	The body composition of the participants will be measured using a state-of-the-art device.	1 year
Blood samples	These samples will be centrifuged, and the serum and plasma will be aliquoted and stored at -80ºC for future analyses.	1 year
Submaximal physical effort test	Sports performance will be evaluated through a submaximal physical effort test.	1 year
Muscle strength	Muscle strength will be measured using a handgrip dynamometer.	1 year

Collaborators and Investigators

• Sponsor: Universidad de Almeria

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Health; Strength; Digestive System; Gut; Intestinal Inflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: TRFE-SI-2023/006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No