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

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

Study Overview

• Status: Recruiting
• Conditions: Aging; Older Adults
• Intervention / Treatment: Dietary supplement: Group 1: Exercise + nutritional supplement (EXNS); Dietary supplement: Group 2: Exercise + placebo nutritional supplement (EXPlaNS)

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Carlos Colado Sánchez, Chair full professor; Phone Number: (9639) 83470; Email: juan.colado@uv.es

Study Locations

• Spain
  • Valencia
    • Valencia, Valencia, Spain, 46010
      • Recruiting
      • Physical activity and Sport Science Faculty, Valencia, Valencia
      • Contact: Juan Carlos Colado Sánchez, Chair full professor; Email: juan.colado@uv.es
      • Principal Investigator: Juan Carlos Colado Sánchez, Chair full profesor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 multicomponent functional exercise program (2 sessions per week, 45-60 minutes each) for 6 months.	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, 3) coordination and agility exercises block.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	Quality of life will be assessed through the WHOQOL-OLD tool	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	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	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.	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	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	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	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	Pre-, mid-, and post-intervention of 6 months
Changes in agility and dynamic balance	Agility and dynamic balance will be assessed through the Timed Up and Go Test	Pre-, mid-, and post-intervention of 6 months
Changes in handgrip strength	Handgrip strength will be assessed through the Handgrip dynamometry (Jamar Hand Dynamometer).	Pre-, mid-, and post-intervention of 6 months
Changes in resting heart rate and blood pressure	Resting heart rate and blood pressure will be assessed through a validated oscillometric sphygmomanometer	Pre-, mid-, and post-intervention of 6 months
Changes in intraocular pressure	Intraocular pressure will be assessed through a non-contact tonometer	Pre-, mid-, and post-intervention of 6 months
Changes in body composition	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.	Pre-, mid-, and post-intervention of 6 months
Demographic characteristics	Age, sex, BMI, regular medication will be assessed.	Pre-, mid-, and post-intervention of 6 months
Baseline physical activity level	Baseline physical activity level will be assessed through the IPAQ-short form questionnaire	Pre-, mid-, and post-intervention of 6 months
Change in Frailty index	Frailty index will be assessed through the FRAIL Scale	Pre-, mid-, and post-intervention of 6 months

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Estimated): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Oxidative stress; Quality of life; Randomized controlled trial; Older adults; Functional exercise; Healthy aging; Nutritional supplement; Non-pharmacological intervention; Multicomponent training; Seasonal immunity
• Additional Relevant MeSH Terms: Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Supplements
• Other Study ID Numbers: 2025-FIS-4026420

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No