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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life scores | The Short Form Health Survey - 12 items (SF-12) is a validated, self-reported instrument used to assess health-related quality of life. It generates two composite scores:
Score range: Norm-based scoring with a mean of 50 and a standard deviation of 10 in the general population. Interpretation:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Luis Felipe, PhD | Contact | +34648885392 | joseluis.felipe@uclm.es | |
| Raquel Aparicio Mera, MsC | Contact | +34689061886 | raquel.aparicio@uclm.es |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31277132 | Background | 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. | |
| 36675688 | 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. |
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Individual participant data (IPD) will not be shared due to privacy concerns and the nature of the study being part of a doctoral thesis. The data are collected under strict confidentiality agreements and are intended solely for internal analysis and academic purposes within the research team. Any future data sharing would require additional ethical approvals and participant consent.
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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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
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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.
|
| 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. |
|
| 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. |
|
| Baseline, Week 12, Week 18 |
| Change in gastrointestinal symptom scores | Measured using the GSRS (Gastrointestinal Symptom Rating Scale), which includes 15 items grouped into five symptom clusters. Score range: 1 to 7 Interpretation: Higher scores reflect greater severity of gastrointestinal symptoms. | Baseline, Week 12, Week 18 |
| Change in 6-minute walk test distance | Distance walked in meters during the 6-minute walk test to assess cardiorespiratory fitness. Unit of measure: meters | Baseline, Week 12, Week 18 |
| Change in handgrip strength | Measured using a hand dynamometer to assess upper body strength. Unit of measure: kilograms | Baseline, Week 12, Week 18 |
| Change in body fat percentage | Measured using bioimpedance analysis to assess body composition. Unit of measure: percent (%) | Baseline, Week 12, Week 18 |
| Change in balance performance | Measured using a pressure platform during a 30-second Romberg test. The outcome includes center of pressure displacement and bilateral weight distribution to assess balance and fall risk. Unit of measure: Sway Index | Baseline, Week 12, Week 18 |
| 32992765 | 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. |
| 22579043 | 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. |
| 37308839 | 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. |