Supplement and Exercise Effects on Stationary Immunity and Health in Older Adults
NCT ID: NCT07251244
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2025-12-15
2026-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 multicomponent functional exercise program (2 sessions per week, 45-60 minutes each) for 6 months.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Valencia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Juan C. Colado
Professor of Physical Education
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Physical activity and Sport Science Faculty, Valencia, Valencia
Valencia, Valencia, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Juan Carlos Colado Sánchez, Chair full professor
Role: CONTACT
Phone: (9639) 83470
Email: [email protected]
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Juan Carlos Colado Sánchez, Chair full professor
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-FIS-4026420
Identifier Type: -
Identifier Source: org_study_id