NCT07251244

Supplement and Exercise Effects on Stationary 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Valencia · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aging
• Older Adults

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-11-26
• Last updated: 2025-12-22

Locations

1 site across 1 country: Spain