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

University of Valencia

Status: Enrolling

Conditions: Aging; Older Adults

Treatments: Dietary Supplement: Group 1: Exercise + nutritional supplement (EXNS); Dietary Supplement: Group 2: Exercise + placebo nutritional supplement (EXPlaNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07251244

2025-FIS-4026420

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Group 1: Exercise + nutritional supplement (EXNS)

Experimental group

Description:

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.

Treatment:

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

Group 2: Exercise + placebo nutritional supplement (EXPlaNS)

Placebo Comparator group

Description:

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.

Treatment:

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