Relationship Between Frailty and Gut Microbiota in Older Adults: An Educational Program for Healthy Aging

NCT07251322 | Completed

• 1 other identifier: FRAGBIOTA
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this pre-experimental study is to describe the relationship between gut microbiota and changes in the degree of frailty in older adults who participated in an educational program. More specifically, the study aims to: determine the gut microbiota profile of community-dwelling older adults, both robust and frail; analyze the effect of a 12-month educational program on gut microbiota; examine the association of gut microbiota with physical function, functional dependency, and physical activity in frail or pre-frail older adults who received the program; investigate its relationship with the risk of malnutrition; relate the gut microbiota profile to quality of life, depressive symptoms, and social support; and, finally, associate gut microbiota with cognitive frailty and sleep quality in this group of older adults who participated in the health promotion educational intervention.

Conditions

Frailty; Microbiota

Keywords

gut microbiota; older adults; educational program

Outcome Measures

Primary Outcomes (1)

• Gut microbiota

  Fecal samples will be collected by the participants themselves at home. For the determination of gut microbiota, the following steps will be carried out: DNA Extraction: DNA will be extracted using the QIAamp DNA Stool Mini Kit (QIAGEN, Barcelona, Spain). Sequencing: Polymerase Chain Reaction (PCR) will be used to amplify the extracted DNA with primers targeting the hypervariable V3 and V4 regions of the bacterial 16S rRNA gene, using the following primers: forward 16S Amplicon PCR primer: 5'TCGTCGGCAGCGTCAGATGTGTATAAGAGACAGCCTACGGGNGGCWGCAG, and reverse 16S Amplicon PCR primer: 5'GTCTCGTGGGCTCGGAGATGTGTATAAGAGACAGGACTACHVGGGTATCTAATCC. Bioinformatic Analysis: Illumina bcl2fastq2 v2.20 software will be used to demultiplex the raw sequences, and the raw data will be imported into the open-source QIIME 2 2020.8 software. Functional Profile Determination: PICRUSt2 will be used to predict potential functional profiles for the sequenced samples.

  At 12 months after the completion of the study

Secondary Outcomes (10)

• Frailty Index

  Day one and at 12 months after the completion of the study

• Functional capacity or physical performance

  Day one and at 12 months after the completion of the study

• Functional dependence

  Day one and at 12 months after the completion of the study

• Physical activity and sleep patterns

  Day one and at 12 months after the completion of the study

• Subjective sleep

  Day one and at 12 months after the completion of the study

Study Arms (1)

Older adults who participated in an educational intervention program called FRAGSALUD

Participants who, after taking part in an educational intervention of a project called FRAGSALUD, either were considered as responders or non-responders to the intervention, measured if they could reduced their levels of Fried's frailty criteria.

Other: Fecal sample collection

Interventions

Fecal sample collection OTHER

Fecal samples were collected by the participants themselves at home, who were instructed to collect a small stool sample either on the morning of the delivery day or the evening of the previous day. For home sample collection, participants were provided with a fecal sample collection kit that included a hermetically sealed sterile container, a fecal sample stabilizer (reference SC0012, Canvax brand), gloves, and a small spoon. Participants were instructed to collect a small fecal sample using the spoon and place it into the container, mixing it by shaking to combine it with the stabilizer.

Older adults who participated in an educational intervention program called FRAGSALUD

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A cohort of participants of the FRAGSALUD project (older adults with at least one Fried's frailty criterion), that will be divided into to responders (if they reduced their levels of frailty) and non-responders (if they did not reduced their levels of frailty) after the FRAGSALUD intervention (an educactional program of four sessions and six telephone calls)

You may qualify if:

• Patients over 65 years of age who present frailty or pre-frailty, assessed using the Fried criteria adapted to the Spanish population
• Patients belonging to the Clinical Management Units participating in the study and who will remain in them for the 12 months of the study
• Patients who are able to attend the Health Center alone or accompanied

You may not qualify if:

• COPD stage III or IV, unstable angina, uncontrolled congestive heart failure, or unstable arrhythmia
• Patients who cannot walk independently or with assistive devices, such as bedridden individuals
• Patients in nursing homes
• Patients with severe cognitive impairment
• Patients who do not understand Spanish or English
• Patients with allergies to plastic or metal

Sponsors & Collaborators

• University of Cadiz: lead
• Fundación ASISA: collaborator

Study Sites (1)

Facultad de Ciencias de la Educación

Puerto Real, Cadiz, 11510, Spain

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cristina Casals Vázquez

  University of Cádiz

  PRINCIPAL INVESTIGATOR

• Juan Corral Pérez

  University of Cádiz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: November 26, 2025
• Study Start: August 25, 2025
• Primary Completion: September 22, 2025
• Study Completion: September 24, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-09

Locations

ES (1)