Supplement and Exercise Effects on Stationary Immunity and Health in Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Valencia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Group 1: Exercise + nutritional supplement (EXNS)
Dietary supplementParticipants 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)
Dietary supplementParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group 1: Exercise + nutritional supplement (EXNS)Experimental treatment 1 intervention
Group B: Group 2: Exercise + placebo nutritional supplement (EXPlaNS)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Pre-, mid-, and post-intervention of 6 months2
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
Time frame
Pre-, mid-, and post-intervention of 6 months3
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.
Time frame
Pre-, mid-, and post-intervention of 6 months4
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.
Time frame
Pre-, mid-, and post-intervention of 6 monthsSecondary outcomes
1
Change in quality of life
Quality of life will be assessed through the WHOQOL-OLD tool
Time frame
Pre-, mid-, and post-intervention of 6 months2
Change in general health perception
General health perception will be assessed through the EQ-5D-5L (EuroQol Group) tool
Time frame
Pre-, mid-, and post-intervention of 6 months3
Change in gastrointestinal symptoms and gut health
Gastrointestinal symptoms and gut health will be assessed through the GSRS tool
Time frame
Pre-, mid-, and post-intervention of 6 months4
Change in frequency and duration of minor illnesses
Frequency and duration of minor illnesses will be assessed through the Jackson Cold Scale.
Time frame
Pre-, mid-, and post-intervention of 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov