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The goal of this clinical trial is to learn whether a natural-origin nutritional supplement, combined with a moderate-intensity functional exercise program, can improve seasonal immunity, perceived health, and oxidative stress in older adults. The study will also assess the safety of this combined intervention.
The main questions it aims to answer are:
Researchers will compare a supplement to a placebo. All participants will follow the same supervised functional exercise program.
Participants will:
This is a randomized, double-blind, placebo-controlled clinical trial with parallel groups, lasting a total of six months. Older adults (≥ 65 years) will participate and be randomly assigned to one of two intervention groups: nutritional supplement or placebo
All groups will follow a moderate-intensity multicomponent functional exercise program consisting of two weekly sessions of 60 minutes each, including mobility, explosive functional strength, and coordination/agility exercises. Three main assessments will be conducted (pre-, mid-, and post-intervention), during which blood samples will be collected to analyze immunological and oxidative stress biomarkers, along with data on functional, physiological, and quality of life variables.
The study is designed to evaluate the efficacy of combining nutritional supplementation with moderate physical exercise on seasonal immunity and overall health in older adults, ensuring blinding of both participants and investigators involved in data collection and analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Exercise + nutritional supplement (EXNS) | Experimental | Participants in this group will receive an oral daily dose of the natural-origin nutritional supplement in combination with a supervised multicomponent functional exercise program (2 sessions per week, 45-60 minutes each) for 6 months. |
|
| Group 2: Exercise + placebo nutritional supplement (EXPlaNS) | Placebo Comparator | Participants in this group will receive a placebo supplement identical in appearance to the active supplement, together with the same multicomponent functional exercise program for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1: Exercise + nutritional supplement (EXNS) | Dietary Supplement | Participants in this group will receive an oral daily dose of the natural-origin nutritional supplement in combination with a supervised moderate-intensity multicomponent and functional exercise program (2 sessions per week, 45-60 minutes each) for 6 months, composed by three exercise blocks: 1) joint mobility and postural control exercises block, 2) explosive functional strength block with three sets of two strength exercises using elastic bands at 70% of 1RM and performed at maximum speed and, 3) coordination and agility exercises block. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in inteleukin 6 (IL-6) | Serum IL-6 levels will be collected through a blood sample in the morning in a fasted state to assess systemic inflammation and immunity | Pre-, mid-, and post-intervention of 6 months |
| Changes in tumor necrosis factor alfa (TNF-α) | Serum TNF-α levels will be collected through a blood sample in the morning in a fasted state to assess chronic inflammation and immune state | Pre-, mid-, and post-intervention of 6 months |
| Changes in immunoglobulin A and G (IgA, IgG) | IgA and IgG levels will be collected through a blood sample in the morning in a fasted state to assess immunological state. | Pre-, mid-, and post-intervention of 6 months |
| Change in high-sensitivity C-reactive protein (hs-CRP) | Serum hs-CRP levels will be collected through a blood sample in the morning in a fasted state to assess systemic inflammatory state. | Pre-, mid-, and post-intervention of 6 months |
| Complete blood count with leukocyte differential for neutrophil-to-lymphocyte ratio (NLR) calculation | Blood count with leukocyte levels will be collected through a blood sample in the morning in a fasted state to assess the NLR | Pre-, mid-, and post-intervention of 6 months |
| Changes in interferon gamma (IFN-γ) | Serum IFN-γ levels will be collected through a blood sample in the morning in a fasted state to assess immunological and inflammatory state | Pre-, mid-, and post-intervention of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | Quality of life will be assessed through the WHOQOL-OLD tool | Pre-, mid-, and post-intervention of 6 months |
| Change in general health perception | General health perception will be assessed through the EQ-5D-5L (EuroQol Group) tool |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Carlos Colado Sánchez, Chair full professor | Contact | (9639) 83470 | juan.colado@uv.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical activity and Sport Science Faculty, Valencia, Valencia | Recruiting | Valencia | Valencia | 46010 | Spain |
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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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| Group 2: Exercise + placebo nutritional supplement (EXPlaNS) | Dietary Supplement | Participants in this group will receive a placebo supplement identical in appearance to the active supplement, together with the same multicomponent functional exercise program for 6 months. |
|
| Change in F2-isoprostanes | Serum F2-isoprostanes levels will be collected through a blood sample in the morning in a fasted state to assess the lipid peroxidation | Pre-, mid-, and post-intervention of 6 months |
| Change in reduced glutathione (GSH) | Serum GSH levels will be collected through a blood sample in the morning in a fasted state to assess the thiol state/antioxidant response. | Pre-, mid-, and post-intervention of 6 months |
| Change in total antioxidant capacity (TAC) | Serum TAC levels will be collected through a blood sample in the morning in a fasted state to assess the antioxidant response. | Pre-, mid-, and post-intervention of 6 months |
| Pre-, mid-, and post-intervention of 6 months |
| Change in gastrointestinal symptoms and gut health | Gastrointestinal symptoms and gut health will be assessed through the GSRS tool | Pre-, mid-, and post-intervention of 6 months |
| Change in frequency and duration of minor illnesses | Frequency and duration of minor illnesses will be assessed through the Jackson Cold Scale. | Pre-, mid-, and post-intervention of 6 months |
| Adherence to supplement and exercise | Adherence to supplement and exercise will be assessed through ad hoc questionnaire | Every day for nutritional supplement and each exercise session during the 6 months of intervention. |
| Satisfaction with the intervention | Satisfaction with the intervention will be assessed through ad hoc questionnaire | Mid- and post-intervention of 6 months |
| Change in distance covered/aerobic capacity | Distance covered/aerobic capacity will be assessed through the 6- Minute walking test | Pre-, mid-, and post-intervention of 6 months |
| Changes in lower limb strength | Lower limb strength will be assessed through the 30-second Chair Stand Test | Pre-, mid-, and post-intervention of 6 months |
| Changes in agility and dynamic balance | Agility and dynamic balance will be assessed through the Timed Up and Go Test | Pre-, mid-, and post-intervention of 6 months |
| Changes in handgrip strength | Handgrip strength will be assessed through the Handgrip dynamometry (Jamar Hand Dynamometer). | Pre-, mid-, and post-intervention of 6 months |
| Changes in resting heart rate and blood pressure | Resting heart rate and blood pressure will be assessed through a validated oscillometric sphygmomanometer | Pre-, mid-, and post-intervention of 6 months |
| Changes in intraocular pressure | Intraocular pressure will be assessed through a non-contact tonometer | Pre-, mid-, and post-intervention of 6 months |
| Changes in body composition | Whole body composition will be assessed through the Bioelectrical impedance analysis (Tanita BC-418). Total body mass, fat mass, lean mass and total body water mass will be measured. | Pre-, mid-, and post-intervention of 6 months |
| Demographic characteristics | Age, sex, BMI, regular medication will be assessed. | Pre-, mid-, and post-intervention of 6 months |
| Baseline physical activity level | Baseline physical activity level will be assessed through the IPAQ-short form questionnaire | Pre-, mid-, and post-intervention of 6 months |
| Change in Frailty index | Frailty index will be assessed through the FRAIL Scale | Pre-, mid-, and post-intervention of 6 months |