Probiotics and Active Aging: Enhancing Gut Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorJose Luis Felipe
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Dietary Supplement
Other interventionA daily oral capsule containing 1 x 10⁹ CFU of Lactiplantibacillus plantarum CECT 7481 (32.5 mg), microcrystalline cellulose (304.1 mg), and magnesium stearate (3.4 mg). Administered once daily before the main meal for 6 weeks. Used to evaluate its effects on gut microbiota and physical health in older adults.
Placebo
Other interventionA daily oral capsule identical in appearance to the probiotic capsule, containing maltodextrin instead of Lactiplantibacillus plantarum. Administered once daily before the main meal for 6 weeks. Used to control for placebo effects in the assessment of probiotic efficacy.
Structured Physical Activity Program
BehavioralA 12-week supervised physical activity program conducted at municipal sports centers. Participants engage in moderate-intensity exercise at least 2 times per week. Designed to assess the impact of physical activity on gut microbiota, physical condition, and quality of life in older adults.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Intervention Group - Physical Activity + ProbioticsExperimental treatment 2 interventions
Group B: Control Group A - Sedentary + ProbioticsActive comparator 1 intervention
Group C: Control Group B - Sedentary + PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in gut microbiota composition
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.
Time frame
Baseline, Week 12, Week 18Secondary outcomes
1
Change in quality of life scores
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
Time frame
Baseline, Week 12, Week 182
Change in gastrointestinal symptom scores
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.
Time frame
Baseline, Week 12, Week 183
Change in 6-minute walk test distance
Distance walked in meters during the 6-minute walk test to assess cardiorespiratory fitness. Unit of measure: meters
Time frame
Baseline, Week 12, Week 184
Change in handgrip strength
Measured using a hand dynamometer to assess upper body strength. Unit of measure: kilograms
Time frame
Baseline, Week 12, Week 18Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jose Luis Felipe
Lead sponsor
University of Castilla-La Mancha
Sponsor institution
Source ClinicalTrials.gov
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