Group 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.
Group 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.
Study 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.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
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
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Physical activity and Sport Science Faculty, Valencia, Valencia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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