Probiotics and Active Aging: Enhancing Gut Health

Not Applicable

Not yet recruiting

• Conditions: Gut -Microbiota; Older People; Physical Activity; Physical Fitness; Mental Health; Probiotic; Healthy

• Registration Number: NCT07033637
• Lead Sponsor: Jose Luis Felipe

Brief Summary

The general objective of this clinical trial is to assess the physical fitness and gut microbiota of older adults, thereby highlighting the importance of focusing on health maintenance. By making use of available resources and fostering collaboration among the elements involved in the study, more specific objectives can be defined:

1. To determine the state of the gut flora in older adults through the analysis of the intestinal microbiota.

2. To identify changes in the intestinal microbiota resulting from the intake of probiotics in older adults.

3. To evaluate the effects of the intestinal microbiota in older adults participating in a training programme.

4. To assess the physical fitness and perceived quality of life in older adults who engage in sport activities supported by technology.

Participants will:

* Perform physical tests such as the 6-Minute Walk Test (6MWT), the Timed Up and Go (TUG), and the Sit-to-Stand test.

* Complete wellbeing questionnaires to assess their perceived quality of life and health status.

* Complete dietary habit questionnaires.

* Provide stool samples for microbiota analysis.

* Take part in exercise interventions or placebo exercise sessions, depending on their assigned group.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-13
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Study Start: 2025-09-01
• Primary Completion: 2026-01-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Adults aged 60 years or older.
• Residents of Castilla-La Mancha or Madrid.
• Able to provide informed consent.
• For the intervention group: enrolled in a municipal physical activity program with a minimum frequency of 2 sessions per week.
• Willing to participate in all assessments and follow study instructions.
• Consent: Participants must provide written informed consent to participate in the study.

Exclusion Criteria

• Recent serious musculoskeletal injuries (e.g., muscle tears, ligament ruptures, fractures).
• Current symptoms during exercise such as chest pain, dizziness, or joint pain.
• Uncontrolled hypertension (≥160/100 mmHg).
• Recent cardiac failure or infectious disease (e.g., meningitis, hepatitis, flu).
• Chronic gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, IBS).
• Regular use of medications affecting gut motility or microbiota (e.g., laxatives >3 times/week).
• Immunodeficiency (e.g., HIV, active cancer).
• Use of antibiotics (oral or parenteral) within 4 weeks prior to the study.
• Regular intake of probiotic supplements or foods (e.g., Actimel) within 2 weeks prior to the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in gut microbiota composition	Baseline, Week 12, Week 18	Assessment of gut microbiota diversity and composition using 16S rRNA sequencing of stool samples. Alpha and beta diversity indices will be calculated to evaluate changes over time and between groups.

Secondary Outcome Measures

Name	Time	Method
Change in quality of life scores	Baseline, Week 12, Week 18	The Short Form Health Survey - 12 items (SF-12) is a validated, self-reported instrument used to assess health-related quality of life. It generates two composite scores: * Physical Component Summary (PCS-12); * Mental Component Summary (MCS-12); Score range: Norm-based scoring with a mean of 50 and a standard deviation of 10 in the general population.; Interpretation: * Scores above 50 indicate better-than-average health-related quality of life.; * Scores below 50 indicate worse-than-average health-related quality of life
Change in gastrointestinal symptom scores	Baseline, Week 12, Week 18	Measured using the GSRS (Gastrointestinal Symptom Rating Scale), which includes 15 items grouped into five symptom clusters.; Score range: 1 to 7 Interpretation: Higher scores reflect greater severity of gastrointestinal symptoms.
Change in 6-minute walk test distance	Baseline, Week 12, Week 18	Distance walked in meters during the 6-minute walk test to assess cardiorespiratory fitness.; Unit of measure: meters
Change in handgrip strength	Baseline, Week 12, Week 18	Measured using a hand dynamometer to assess upper body strength.; Unit of measure: kilograms
Change in body fat percentage	Baseline, Week 12, Week 18	Measured using bioimpedance analysis to assess body composition.; Unit of measure: percent (%)
Change in balance performance	Baseline, Week 12, Week 18	Measured using a pressure platform during a 30-second Romberg test. The outcome includes center of pressure displacement and bilateral weight distribution to assess balance and fall risk.; Unit of measure: Sway Index