Probiotics and Active Aging: Enhancing Gut Health

N/ANot Yet RecruitingNCT07033637

Jose Luis Felipe90 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Gut -Microbiota Older People

Interventions

Dietary SupplementOTHER

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.

PlaceboOTHER

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.

Structured Physical Activity ProgramBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.