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

NCT ID: NCT07251322

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-25
• Study Completion Date: 2025-09-24

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.

Detailed Description

This non-randomized pre-experimental study was conducted in the province of Cádiz, Spain. A total of 14 older adults participated, all of whom had previously taken part in the intervention group of the randomized experimental project called Fragsalud, which aimed to improve frailty through educational sessions. During that project, frailty was assessed using the Fried criteria, and physical condition, physical activity, and sleep were evaluated through accelerometry, as well as questionnaires on nutritional habits, depressive symptoms, social support, instrumental and basic activities of daily living, quality of life, cognition, and sleep, at the beginning of the study, at 6 months, and at the end of the study at 12 months. For the Fragbiota project, once Fragsalud was completed, participants were analyzed based on whether or not they responded to the educational intervention. That is, the gut microbiota of those subjects who, after 12 months, had reduced the Fried frailty criteria was compared with those who, despite receiving the educational intervention, had maintained the same Fried levels or had worsened. Furthermore, this gut microbiota was related to the secondary variables previously assessed in the Fragsalud project. This study complied with biomedical ethical guidelines, including Good Clinical Practice (CPMP/ICH/135/95), the Oviedo Convention, the Universal Declaration of Human Rights, CIOMS/WHO ethical guidelines, and the Declaration of Helsinki, ensuring the dignity, rights, and safety of participants. Additionally, participants provided informed consent after receiving detailed explanations, both in writing and verbally, regarding the objectives, procedures, and risks of the study.

Conditions

Frailty; Microbiota

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Fecal sample collection

Intervention Type: 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.

Interventions

Fecal sample collection

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación ASISA

UNKNOWN

Sponsor Role: collaborator

University of Cadiz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cristina Casals Vázquez

Role: PRINCIPAL_INVESTIGATOR

University of Cádiz

Juan Corral Pérez

Role: PRINCIPAL_INVESTIGATOR

University of Cádiz

Locations

Facultad de Ciencias de la Educación

Puerto Real, Cadiz, Spain

Countries

Spain

Other Identifiers

FRAGBIOTA

Identifier Type: -

Identifier Source: org_study_id