Probiotics and Active Aging: Enhancing Gut Health

Official title

Promoting Health Through Symbiosis: Exploring the Relationship Between Gut Microbiota, Probiotics, and Physical Activity in Older Adults

Overview

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

• Other Dietary 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.
• Other Placebo
  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.
• Behavioral Structured 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.

Primary outcome measures

• Change in gut microbiota composition [Time frame: Baseline, Week 12, Week 18]

Secondary outcome measures (6)

• Change in quality of life scores [Time frame: Baseline, Week 12, Week 18]
• Change in gastrointestinal symptom scores [Time frame: Baseline, Week 12, Week 18]
• Change in 6-minute walk test distance [Time frame: Baseline, Week 12, Week 18]
• Change in handgrip strength [Time frame: Baseline, Week 12, Week 18]
• Change in body fat percentage [Time frame: Baseline, Week 12, Week 18]
• Change in balance performance [Time frame: Baseline, Week 12, Week 18]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Thomas E, Battaglia G, Patti A, Brusa J, Leonardi V, Palma A, Bellafiore M. Physical activity programs for balance and fall prevention in elderly: A systematic review. Medicine (Baltimore). 2019 Jul;98(27):e16218. doi: 10.1097/MD.0000000000016218. PMID 31277132
• Nascimento V, Fonseca C, Pinho LG, Lopes MJ. Person-Centered Health Intervention Programs, Provided at Home to Older Adults with Multimorbidity and Their Caregivers: Protocol for a Systematic Review. J Pers Med. 2022 Dec 23;13(1):27. doi: 10.3390/jpm13010027. PMID 36675688
• Marttinen M, Ala-Jaakkola R, Laitila A, Lehtinen MJ. Gut Microbiota, Probiotics and Physical Performance in Athletes and Physically Active Individuals. Nutrients. 2020 Sep 25;12(10):2936. doi: 10.3390/nu12102936. PMID 32992765
• Barnett K, Mercer SW, Norbury M, Watt G, Wyke S, Guthrie B. Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study. Lancet. 2012 Jul 7;380(9836):37-43. doi: 10.1016/S0140-6736(12)60240-2. Epub 2012 May 10. PMID 22579043
• Aya V, Jimenez P, Munoz E, Ramirez JD. Effects of exercise and physical activity on gut microbiota composition and function in older adults: a systematic review. BMC Geriatr. 2023 Jun 12;23(1):364. doi: 10.1186/s12877-023-04066-y. PMID 37308839

Identifiers

NCT: NCT07033637 · IGOID3

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗