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NCT Number: NCT07251244

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

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.

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Key information

Conditions

Aging Older Adults

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical activity and Sport Science Faculty, Valencia, Valencia

Valencia, 46010, Spain

Location status: Recruiting

Location contact

Juan Carlos Colado Sánchez, Chair full profesor

PRINCIPAL_INVESTIGATOR

Juan Carlos Colado Sánchez, Chair full professor

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Changes in inteleukin 6 (IL-6)

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

    Serum IL-6 levels will be collected through a blood sample in the morning in a fasted state to assess systemic inflammation and immunity

  2. Changes in tumor necrosis factor alfa (TNF-α)

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

    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

  3. Changes in immunoglobulin A and G (IgA, IgG)

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

    IgA and IgG levels will be collected through a blood sample in the morning in a fasted state to assess immunological state.

  4. Change in high-sensitivity C-reactive protein (hs-CRP)

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

    Serum hs-CRP levels will be collected through a blood sample in the morning in a fasted state to assess systemic inflammatory state.

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

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

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

  6. Changes in interferon gamma (IFN-γ)

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

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

  7. Change in F2-isoprostanes

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

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

  8. Change in reduced glutathione (GSH)

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

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

  9. Change in total antioxidant capacity (TAC)

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

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

Secondary outcomes

  1. Change in quality of life

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

    Quality of life will be assessed through the WHOQOL-OLD tool

  2. Change in general health perception

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

    General health perception will be assessed through the EQ-5D-5L (EuroQol Group) tool

  3. Change in gastrointestinal symptoms and gut health

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

    Gastrointestinal symptoms and gut health will be assessed through the GSRS tool

  4. Change in frequency and duration of minor illnesses

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

    Frequency and duration of minor illnesses will be assessed through the Jackson Cold Scale.

  5. Adherence to supplement and exercise

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

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

  6. Satisfaction with the intervention

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

    Satisfaction with the intervention will be assessed through ad hoc questionnaire

  7. Change in distance covered/aerobic capacity

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

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

  8. Changes in lower limb strength

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

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

  9. Changes in agility and dynamic balance

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

    Agility and dynamic balance will be assessed through the Timed Up and Go Test

  10. Changes in handgrip strength

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

    Handgrip strength will be assessed through the Handgrip dynamometry (Jamar Hand Dynamometer).

  11. Changes in resting heart rate and blood pressure

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

    Resting heart rate and blood pressure will be assessed through a validated oscillometric sphygmomanometer

  12. Changes in intraocular pressure

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

    Intraocular pressure will be assessed through a non-contact tonometer

  13. Changes in body composition

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

    Whole body composition will be assessed through the Bioelectrical impedance analysis (Tanita BC-418). Total body mass, fat mass, lean mass and total body water mass will be measured.

  14. Demographic characteristics

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

    Age, sex, BMI, regular medication will be assessed.

  15. Baseline physical activity level

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

    Baseline physical activity level will be assessed through the IPAQ-short form questionnaire

  16. Change in Frailty index

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

    Frailty index will be assessed through the FRAIL Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Carlos Colado Sánchez, Chair full professor

CONTACT

[email protected]

(9639) 83470

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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