Relationship Between Frailty and Gut Microbiota in Older Adults: Relevance for a Healthy Aging Education Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Cadiz
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Gut microbiota
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Gut microbiota
Time Frame: At 12 months after the completion of the study
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.
Secondary Outcomes
- 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)
- Social support(Day one and at 12 months after the completion of the study)
- Quality of life assessment(Day one and at 12 months after the completion of the study)
- Depressive symptoms(Day one and at 12 months after the completion of the study)
- Cognitive function assessment(Day one and at 12 months after the completion of the study)
- Risk of malnutrition(Day one and at 12 months after the completion of the study)