Gut -Microbiota, Healthy, Mental Health, Older People, Physical Activity, Physical Fitness, Probiotic
Conditions
Keywords
older people, gut microbiota, physical activity
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.
Interventions
OTHERDietary Supplement
A 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.
OTHERPlacebo
A 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.
BEHAVIORALStructured Physical Activity Program
A 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.
Sponsors
Jose Luis Felipe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
In this double-blind study, both participants and outcomes assessors are masked to the intervention assignment. The probiotic and placebo capsules are identical in appearance, taste, and packaging, ensuring that participants cannot distinguish between them. Outcomes assessors responsible for evaluating physical condition, microbiota composition, and quality of life are also blinded to group allocation to minimize assessment bias. The investigators administering the interventions are not blinded due to logistical requirements in distributing the correct supplement.
Intervention model description
This interventional study follows a parallel assignment model with three distinct groups of older adults (≥60 years), each comprising 30 participants: Group 1 (Intervention Group): Participants engage in a structured physical activity program and later receive a probiotic supplement (AB-DR7). Group 2 (Control Group A): Sedentary participants who receive the probiotic supplement without engaging in physical activity. Group 3 (Control Group B): Sedentary participants who receive a placebo and do not engage in physical activity. The study is conducted over 18 weeks, divided into two main phases: First 12 weeks: Group 1 performs physical activity; Groups 2 and 3 maintain their usual sedentary lifestyle. Following 6 weeks: Groups 1 and 2 begin probiotic intake; Group 3 continues with placebo. The model is designed to evaluate the independent and combined effects of physical activity and probiotic supplementation on gut microbiota composition, physical condition, and quality of life in old
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| Change in handgrip strength | Baseline, Week 12, Week 18 | Measured using a hand dynamometer to assess upper body strength. Unit of measure: kilograms |
Contacts
Primary ContactJose Luis Felipe, PhD
Backup ContactRaquel Aparicio Mera, MsC
Outcome results
None listed