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

NCT06396728 | Not Yet Recruiting DMC

• 1 other identifier: TRFE-SI-2023/006
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Gut; Health; Digestive System; Intestinal Inflammation; Strength

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Body composition

  1 year

• Blood samples

  1 year

• Submaximal physical effort test

  1 year

• Muscle strength

  1 year

Study Arms (2)

Consumption of GI BIOTICS 100B UFC

EXPERIMENTAL

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

Dietary Supplement: GI BIOTICS 100B UFC

Placebo Consumption

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo Consumption

Interventions

GI BIOTICS 100B UFC DIETARY_SUPPLEMENT

Consumption of GI BIOTICS 100B UFC.

Consumption of GI BIOTICS 100B UFC

Placebo Consumption DIETARY_SUPPLEMENT

Consumption of a placebo capsule.

Placebo Consumption

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Universidad de Almería

Almería, 04120, Spain

Location

Central Study Contacts

Borja Martinez Tellez, PhD

CONTACT

+34 950215334; borjammt@ual.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study involves a total of 44 men who will be randomly selected to be part of two groups: one who will consume a placebo capsule and another who will consume GI BIOTICS 100B UFC daily for a period of 8 weeks.

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 2, 2024
• Study Start: June 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: March 1, 2025
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

ES (1)