Aging, Older Adults
Conditions
Keywords
Older adults, Nutritional supplement, Functional exercise, Seasonal immunity, Oxidative stress, Multicomponent training, Healthy aging, Quality of life, Non-pharmacological intervention, Randomized controlled trial
Brief summary
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: * Does the combination of supplementation and exercise enhance immune function during seasonal changes? * Does it reduce oxidative stress and improve perceived health and functional capacity? Researchers will compare a supplement to a placebo. All participants will follow the same supervised functional exercise program. Participants will: * Take a daily nutritional supplement for 6 months. * Attend two weekly functional exercise sessions (60 minutes each), including mobility, explosive strength, and coordination/agility training. * Complete three assessments (before, midway, and after the intervention) including blood tests, physical function evaluations, and quality of life questionnaires.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTGroup 1: Exercise + nutritional supplement (EXNS)
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.
DIETARY_SUPPLEMENTGroup 2: Exercise + placebo nutritional supplement (EXPlaNS)
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.
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 65 years or older * Functional independence, defined as the ability to perform activities of daily living without assistance * Sufficient cognitive capacity to understand instructions and complete questionnaires, assessed through interview or brief cognitive screening if necessary * Not immunosuppressed * Not regular users of antioxidant or immunomodulatory supplements * Ability and availability to attend exercise sessions and scheduled assessments throughout the six-month study period * Commitment to maintain stable dietary and physical activity habits during the intervention
Exclusion criteria
* Active autoimmune diseases or clinically relevant immunosuppression * Use of corticosteroids or immunosuppressive drugs in the 4 weeks prior to study initiation * Active infection or compatible symptoms (fever, cough, diarrhea) in the 2 weeks prior to any measurement * Unstable cardiovascular conditions or medical contraindications for moderate physical exercise * Moderate to severe cognitive impairment that prevents proper participation in the scheduled activities * Participation in another clinical trial in the last 3 months * Known allergy or hypersensitivity to the supplement or any of its excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in inteleukin 6 (IL-6) | Pre-, mid-, and post-intervention of 6 months | Serum IL-6 levels will be collected through a blood sample in the morning in a fasted state to assess systemic inflammation and immunity |
| Changes in tumor necrosis factor alfa (TNF-α) | Pre-, mid-, and post-intervention of 6 months | 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 |
| Changes in immunoglobulin A and G (IgA, IgG) | Pre-, mid-, and post-intervention of 6 months | IgA and IgG levels will be collected through a blood sample in the morning in a fasted state to assess immunological state. |
| Change in high-sensitivity C-reactive protein (hs-CRP) | Pre-, mid-, and post-intervention of 6 months | Serum hs-CRP levels will be collected through a blood sample in the morning in a fasted state to assess systemic inflammatory state. |
| Complete blood count with leukocyte differential for neutrophil-to-lymphocyte ratio (NLR) calculation | Pre-, mid-, and post-intervention of 6 months | Blood count with leukocyte levels will be collected through a blood sample in the morning in a fasted state to assess the NLR |
| Changes in interferon gamma (IFN-γ) | Pre-, mid-, and post-intervention of 6 months | Serum IFN-γ levels will be collected through a blood sample in the morning in a fasted state to assess immunological and inflammatory state |
| Change in F2-isoprostanes | Pre-, mid-, and post-intervention of 6 months | Serum F2-isoprostanes levels will be collected through a blood sample in the morning in a fasted state to assess the lipid peroxidation |
| Change in reduced glutathione (GSH) | Pre-, mid-, and post-intervention of 6 months | Serum GSH levels will be collected through a blood sample in the morning in a fasted state to assess the thiol state/antioxidant response. |
| Change in total antioxidant capacity (TAC) | Pre-, mid-, and post-intervention of 6 months | Serum TAC levels will be collected through a blood sample in the morning in a fasted state to assess the antioxidant response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in handgrip strength | Pre-, mid-, and post-intervention of 6 months | Handgrip strength will be assessed through the Handgrip dynamometry (Jamar Hand Dynamometer). |
| Changes in resting heart rate and blood pressure | Pre-, mid-, and post-intervention of 6 months | Resting heart rate and blood pressure will be assessed through a validated oscillometric sphygmomanometer |
| Changes in intraocular pressure | Pre-, mid-, and post-intervention of 6 months | Intraocular pressure will be assessed through a non-contact tonometer |
| Satisfaction with the intervention | Mid- and post-intervention of 6 months | Satisfaction with the intervention will be assessed through ad hoc questionnaire |
| Demographic characteristics | Pre-, mid-, and post-intervention of 6 months | Age, sex, BMI, regular medication will be assessed. |
| Baseline physical activity level | Pre-, mid-, and post-intervention of 6 months | Baseline physical activity level will be assessed through the IPAQ-short form questionnaire |
| Change in Frailty index | Pre-, mid-, and post-intervention of 6 months | Frailty index will be assessed through the FRAIL Scale |
| Changes in body composition | Pre-, mid-, and post-intervention of 6 months | 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. |
| Change in gastrointestinal symptoms and gut health | Pre-, mid-, and post-intervention of 6 months | Gastrointestinal symptoms and gut health will be assessed through the GSRS tool |
| Change in frequency and duration of minor illnesses | Pre-, mid-, and post-intervention of 6 months | Frequency and duration of minor illnesses will be assessed through the Jackson Cold Scale. |
| Adherence to supplement and exercise | Every day for nutritional supplement and each exercise session during the 6 months of intervention. | Adherence to supplement and exercise will be assessed through ad hoc questionnaire |
| Change in quality of life | Pre-, mid-, and post-intervention of 6 months | Quality of life will be assessed through the WHOQOL-OLD tool |
| Change in general health perception | Pre-, mid-, and post-intervention of 6 months | General health perception will be assessed through the EQ-5D-5L (EuroQol Group) tool |
| Change in distance covered/aerobic capacity | Pre-, mid-, and post-intervention of 6 months | Distance covered/aerobic capacity will be assessed through the 6- Minute walking test |
| Changes in lower limb strength | Pre-, mid-, and post-intervention of 6 months | Lower limb strength will be assessed through the 30-second Chair Stand Test |
| Changes in agility and dynamic balance | Pre-, mid-, and post-intervention of 6 months | Agility and dynamic balance will be assessed through the Timed Up and Go Test |
Countries
Spain
Contacts
Primary ContactJuan Carlos Colado Sánchez, Chair full professor
Outcome results
None listed