Supplement and Exercise Effects on Stationary Immunity and Health in Older Adults

Official title

Effects of a Nutritional Supplement and Functional Exercise Program on Seasonal Immunity, Perceived Health, and Oxidative Stress in Older Adults

Overview

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.

Interventions

• 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,
• 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.

Primary outcome measures

• Changes in inteleukin 6 (IL-6) [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Changes in tumor necrosis factor alfa (TNF-α) [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Changes in immunoglobulin A and G (IgA, IgG) [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Change in high-sensitivity C-reactive protein (hs-CRP) [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Complete blood count with leukocyte differential for neutrophil-to-lymphocyte ratio (NLR) calculation [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Changes in interferon gamma (IFN-γ) [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Change in F2-isoprostanes [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Change in reduced glutathione (GSH) [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Change in total antioxidant capacity (TAC) [Time frame: Pre-, mid-, and post-intervention of 6 months]

Secondary outcome measures (12)

• Change in quality of life [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Change in general health perception [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Change in gastrointestinal symptoms and gut health [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Change in frequency and duration of minor illnesses [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Adherence to supplement and exercise [Time frame: Every day for nutritional supplement and each exercise session during the 6 months of intervention.]
• Satisfaction with the intervention [Time frame: Mid- and post-intervention of 6 months]
• Change in distance covered/aerobic capacity [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Changes in lower limb strength [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Changes in agility and dynamic balance [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Changes in handgrip strength [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Changes in resting heart rate and blood pressure [Time frame: Pre-, mid-, and post-intervention of 6 months]
• Changes in intraocular pressure [Time frame: Pre-, mid-, and post-intervention of 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

Spain · 1 center

• Physical activity and Sport Science Faculty, Valencia, Valencia — Valencia

Identifiers

NCT: NCT07251244 · 2025-FIS-4026420

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗