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

University of Valencia60 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Interventions

Group 1: Exercise + nutritional supplement (EXNS)DIETARY_SUPPLEMENT

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)DIETARY_SUPPLEMENT

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

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 months

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 months

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 months

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 months

Complete blood count with leukocyte differential for neutrophil-to-lymphocyte ratio (NLR) calculation

Blood count with leukocyte levels will be collected through a blood sample in the morning in a fasted state to assess the NLR

Time frame: Pre-, mid-, and post-intervention of 6 months

Changes in interferon gamma (IFN-γ)

Serum IFN-γ levels will be collected through a blood sample in the morning in a fasted state to assess immunological and inflammatory state

Time frame: Pre-, mid-, and post-intervention of 6 months

Change in F2-isoprostanes

Serum F2-isoprostanes levels will be collected through a blood sample in the morning in a fasted state to assess the lipid peroxidation

Time frame: Pre-, mid-, and post-intervention of 6 months

Change in reduced glutathione (GSH)

Serum GSH levels will be collected through a blood sample in the morning in a fasted state to assess the thiol state/antioxidant response.

Time frame: Pre-, mid-, and post-intervention of 6 months

Change in total antioxidant capacity (TAC)

Serum TAC levels will be collected through a blood sample in the morning in a fasted state to assess the antioxidant response.

Time frame: Pre-, mid-, and post-intervention of 6 months

Secondary Outcomes

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 months

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 months

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 months

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 months

Adherence to supplement and exercise

Adherence to supplement and exercise will be assessed through ad hoc questionnaire

Time frame: Every day for nutritional supplement and each exercise session during the 6 months of intervention.

Satisfaction with the intervention

Satisfaction with the intervention will be assessed through ad hoc questionnaire

Time frame: Mid- and post-intervention of 6 months

Change in distance covered/aerobic capacity

Distance covered/aerobic capacity will be assessed through the 6- Minute walking test

Time frame: Pre-, mid-, and post-intervention of 6 months

Changes in lower limb strength

Lower limb strength will be assessed through the 30-second Chair Stand Test

Time frame: Pre-, mid-, and post-intervention of 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts