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

NCT07251244 | Recruiting

• 1 other identifier: 2025-FIS-4026420
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging; Older Adults

Keywords

Older adults; Nutritional supplement; Functional exercise; Seasonal immunity; Oxidative stress; Multicomponent training; Healthy aging; Quality of life; Non-pharmacological intervention; Randomized controlled trial

Outcome Measures

Primary Outcomes (9)

• 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

  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

  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.

  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.

  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

  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

  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

  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.

  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.

  Pre-, mid-, and post-intervention of 6 months

Secondary Outcomes (16)

• Change in quality of life

  Pre-, mid-, and post-intervention of 6 months

• Change in general health perception

  Pre-, mid-, and post-intervention of 6 months

• Change in gastrointestinal symptoms and gut health

  Pre-, mid-, and post-intervention of 6 months

• Change in frequency and duration of minor illnesses

  Pre-, mid-, and post-intervention of 6 months

• Adherence to supplement and exercise

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

Study Arms (2)

Group 1: Exercise + nutritional supplement (EXNS)

EXPERIMENTAL

Participants in this group will receive an oral daily dose of the natural-origin nutritional supplement in combination with a supervised multicomponent functional exercise program (2 sessions per week, 45-60 minutes each) for 6 months.

Dietary Supplement: Group 1: Exercise + nutritional supplement (EXNS)

Group 2: Exercise + placebo nutritional supplement (EXPlaNS)

PLACEBO COMPARATOR

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.

Dietary Supplement: Group 2: Exercise + placebo nutritional supplement (EXPlaNS)

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 1: Exercise + nutritional supplement (EXNS)

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.

Group 2: Exercise + placebo nutritional supplement (EXPlaNS)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Physical activity and Sport Science Faculty, Valencia, Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Juan Carlos Colado Sánchez, Chair full professor

CONTACT

(9639) 83470; juan.colado@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Education

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

ES (1)