Nutritional supplement plus functional exercise to boost immunity and health in older adults
Effects of a Nutritional Supplement and Functional Exercise Program on Seasonal Immunity, Perceived Health, and Oxidative Stress in Older Adults
NA · University of Valencia · NCT07251244
This project will see if taking a daily natural-origin supplement while doing supervised twice-weekly functional exercise for six months helps people 65 and older improve seasonal immune responses, reduce oxidative stress, and feel and function better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Valencia (other) |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT07251244 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled trial will assign adults aged 65 and older to either a daily natural nutritional supplement or a matching placebo while all participants follow a supervised, moderate-intensity functional exercise program twice weekly for six months. Assessments occur before, midway, and after the intervention and include blood draws to measure immunological and oxidative stress biomarkers. Investigators will also collect data on physical function, physiological measures, and quality of life. Safety and adverse events will be monitored throughout the study.
Who should consider this trial
Good fit: Independent adults aged 65 or older who can attend supervised exercise sessions, are not immunosuppressed, and do not regularly use antioxidant or immunomodulatory supplements.
Not a fit: People with active autoimmune disease, recent corticosteroid or immunosuppressive drug use, unstable cardiovascular conditions, active infection, or an inability to participate in moderate exercise are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, the combined supplement and exercise program could strengthen seasonal immune responses, lower oxidative stress, and improve perceived health and physical function in older adults.
How similar studies have performed: Moderate exercise is well documented to support immune function in older adults and some supplements reduce oxidative stress, but combined, double-blind randomized trials of supplement-plus-exercise are limited and have shown mixed results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Valencia, Valencia
- Physical activity and Sport Science Faculty, Valencia, Valencia — Valencia, Valencia, Spain (RECRUITING)
Study contacts
- Study coordinator: Juan Carlos Colado Sánchez, Chair full professor
- Email: juan.colado@uv.es
- Phone: (9639) 83470
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aging, Older Adults, Older adults, Nutritional supplement, Functional exercise, Seasonal immunity, Oxidative stress, Multicomponent training