Promoting Health Through Symbiosis: Exploring the Relationship Between Gut Microbiota, Probiotics, and Physical Activity in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Change in gut microbiota composition
研究概览
简要总结
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:
- To determine the state of the gut flora in older adults through the analysis of the intestinal microbiota.
- To identify changes in the intestinal microbiota resulting from the intake of probiotics in older adults.
- To evaluate the effects of the intestinal microbiota in older adults participating in a training programme.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in gut microbiota composition
时间窗: 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.
次要结局
- 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)
- Change in balance performance(Baseline, Week 12, Week 18)
研究者
Jose Luis Felipe
Senior Lecturer
University of Castilla-La Mancha