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

NCT ID: NCT06396728

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-03-31

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 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Consumption of GI BIOTICS 100B UFC

Participants will consume one GI BIOTICS 100B UFC capsule daily for a period of 8 weeks; n=22.

Group Type: EXPERIMENTAL

GI BIOTICS 100B UFC

Intervention Type: DIETARY_SUPPLEMENT

Consumption of GI BIOTICS 100B UFC.

Placebo Consumption

Participants will consume one placebo capsule daily for a period of 8 weeks; n=22.

Group Type: PLACEBO_COMPARATOR

Placebo Consumption

Intervention Type: DIETARY_SUPPLEMENT

Consumption of a placebo capsule.

Interventions

GI BIOTICS 100B UFC

Consumption of GI BIOTICS 100B UFC.

Intervention Type: DIETARY_SUPPLEMENT

Placebo Consumption

Consumption of a placebo capsule.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Almeria

OTHER

Sponsor Role: lead

Responsible Party

Borja Martínez Tellez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad de Almería

Almería, , Spain

Countries

Spain

Central Contacts

Borja Martinez Tellez, PhD

Role: CONTACT

borjammt@ual.es

+34 950215334 ext. +34

Other Identifiers

TRFE-SI-2023/006

Identifier Type: -

Identifier Source: org_study_id