Probiotics and Active Aging: Enhancing Gut Health

NCT07033637 | Not Yet Recruiting DMC

• 1 other identifier: IGOID3
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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:

• 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.

Conditions

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

Keywords

older people; gut microbiota; physical activity

Outcome Measures

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.

  Baseline, Week 12, Week 18

Secondary Outcomes (6)

• Change in quality of life scores

  Baseline, Week 12, Week 18

• Change in gastrointestinal symptom scores

  Baseline, Week 12, Week 18

• Change in 6-minute walk test distance

  Baseline, Week 12, Week 18

• Change in handgrip strength

  Baseline, Week 12, Week 18

• Change in body fat percentage

  Baseline, Week 12, Week 18

Study Arms (3)

Intervention Group - Physical Activity + Probiotics

EXPERIMENTAL

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.

Other: Dietary Supplement; Behavioral: Structured Physical Activity Program

Control Group A - Sedentary + Probiotics

ACTIVE COMPARATOR

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.

Other: Dietary Supplement

Control Group B - Sedentary + Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Dietary Supplement OTHER

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.

Control Group A - Sedentary + Probiotics; Intervention Group - Physical Activity + Probiotics

Placebo OTHER

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.

Control Group B - Sedentary + Placebo

Structured Physical Activity Program BEHAVIORAL

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.

Intervention Group - Physical Activity + Probiotics

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jose Luis Felipe: lead

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Psychological Well-Being

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Jose Luis Felipe, PhD

CONTACT

+34648885392; joseluis.felipe@uclm.es

Raquel Aparicio Mera, MsC

CONTACT

+34689061886; raquel.aparicio@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: 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

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 24, 2025
• Study Start: September 1, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share