Probiotics and Active Aging: Enhancing Gut Health (PAAEGH)

Jose Luis Felipe

Status: Begins enrollment in 1 month

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

Treatments: Behavioral: Structured Physical Activity Program; Other: Dietary Supplement; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07033637

IGOID3

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Intervention Group - Physical Activity + Probiotics

Experimental group

Description:

Participants in this arm will engage in a structured physical activity program for 12 weeks, followed by a 6-week period during which they will continue the exercise regimen and begin daily intake of a probiotic supplement (AB-DR7, containing Lactiplantibacillus plantarum CECT 7481). The goal is to assess the combined effects of physical activity and probiotics on gut microbiota, physical condition, and quality of life in older adults.

Treatment:

Other: Dietary Supplement

Behavioral: Structured Physical Activity Program

Control Group A - Sedentary + Probiotics

Active Comparator group

Description:

Participants in this arm will maintain their usual sedentary lifestyle throughout the study. After the initial 12-week observation period, they will begin a 6-week daily intake of the same probiotic supplement (AB-DR7). This arm is used to evaluate the effects of probiotics alone on gut microbiota and health indicators in the absence of physical activity.

Treatment:

Other: Dietary Supplement

Control Group B - Sedentary + Placebo

Placebo Comparator group

Description:

Participants in this arm will maintain a sedentary lifestyle and receive a placebo capsule identical in appearance to the probiotic, but containing maltodextrin instead of Lactiplantibacillus plantarum. This group serves as the baseline comparator to assess the natural variation in outcomes without intervention.

Treatment:

Other: Placebo