AgingNCT07251244
Supplement and Exercise Effects on Stationary Immunity and Health in Older Adults
A study testing Group 1: Exercise + nutritional supplement (EXNS) in people with Aging and Older Adults, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging, Older Adults
- What is being tested?
- Group 1: Exercise + nutritional supplement (EXNS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Physical activity and Sport Science Faculty, Valencia, Valencia
Valencia, Valencia, 46010
Juan Carlos Colado Sánchez, Chair full professor, juan.colado@uv.es
Juan Carlos Colado Sánchez, Chair full profesor
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Aging, Older Adults
- Being tested
- Group 1: Exercise + nutritional supplement (EXNS), Group 2: Exercise + placebo nutritional supplement (EXPlaNS)
- Keywords
- Older adults, Nutritional supplement, Functional exercise, Seasonal immunity, Oxidative stress, Multicomponent training, Healthy aging, Quality of life, Non-pharmacological intervention, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Group 2: Exercise + placebo nutritional supplement (EXPlaNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Pre-, mid-, and post-intervention of 6 months
Secondary outcomes (16)
Change in quality of life
Quality of life will be assessed through the WHOQOL-OLD tool
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-, mid-, and post-intervention of 6 months
Changes in handgrip strength
Handgrip strength will be assessed through the Handgrip dynamometry (Jamar Hand Dynamometer).
Measured: 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
Measured: Pre-, mid-, and post-intervention of 6 months
Changes in intraocular pressure
Intraocular pressure will be assessed through a non-contact tonometer
Measured: 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.
Measured: Pre-, mid-, and post-intervention of 6 months
Demographic characteristics
Age, sex, BMI, regular medication will be assessed.
Measured: 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
Measured: Pre-, mid-, and post-intervention of 6 months
Change in Frailty index
Frailty index will be assessed through the FRAIL Scale
Measured: Pre-, mid-, and post-intervention of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start15 Dec 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan C. Colado, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251244
- Sponsor's protocol ID
- 2025-FIS-4026420
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Nutritional Supplement and Functional Exercise Program on Seasonal Immunity, Perceived Health, and Oxidative Stress in Older Adults
- ClinicalTrials.gov ID
- NCT07251244
- Acronym / sponsor ID
- 2025-FIS-4026420
- Conditions
- Aging, Older Adults
- Keywords
- Older adults, Nutritional supplement, Functional exercise, Seasonal immunity, Oxidative stress, Multicomponent training, Healthy aging, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Exercise + nutritional supplement (EXNS) | Experimental | 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 multicomponent functional exercise program (2 sessions per week, 45-60 minutes each) for 6 months. |
| Group 2: Exercise + placebo nutritional supplement (EXPlaNS) | Placebo comparator | 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Group 1: Exercise + nutritional supplement (EXNS) |
| 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) |
Primary outcome
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
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
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.
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.
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
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
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
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.
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.
16 secondary outcomes
Change in quality of life
Time frame: Pre-, mid-, and post-intervention of 6 months
Change in general health perception
Time frame: Pre-, mid-, and post-intervention of 6 months
Change in gastrointestinal symptoms and gut health
Time frame: Pre-, mid-, and post-intervention of 6 months
Change in frequency and duration of minor illnesses
Time frame: Pre-, mid-, and post-intervention of 6 months
Adherence to supplement and exercise
Time frame: Every day for nutritional supplement and each exercise session during the 6 months of intervention.
Satisfaction with the intervention
Time frame: Mid- and post-intervention of 6 months
Change in distance covered/aerobic capacity
Time frame: Pre-, mid-, and post-intervention of 6 months
Changes in lower limb strength
Time frame: Pre-, mid-, and post-intervention of 6 months
Changes in agility and dynamic balance
Time frame: Pre-, mid-, and post-intervention of 6 months
Changes in handgrip strength
Time frame: Pre-, mid-, and post-intervention of 6 months
Changes in resting heart rate and blood pressure
Time frame: Pre-, mid-, and post-intervention of 6 months
Changes in intraocular pressure
Time frame: Pre-, mid-, and post-intervention of 6 months
Changes in body composition
Time frame: Pre-, mid-, and post-intervention of 6 months
Demographic characteristics
Time frame: Pre-, mid-, and post-intervention of 6 months
Baseline physical activity level
Time frame: Pre-, mid-, and post-intervention of 6 months
Change in Frailty index
Time frame: Pre-, mid-, and post-intervention of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
Related trials for Aging
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Recruiting
Study Evaluating the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults
Healthy Aging
RecruitingObservational study
Westlake Aging Cohort (WeAC)
Aging, Cognition Improvement
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
Recruiting
Feasibility of A Smartphone Application Intervention in Community Settings: A Pretest-Posttest Pilot Study
Aging, Dementia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: Exercise + nutritional supplement (EXNS) in people with Aging and Older Adults, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Carlos Colado Sánchez, Chair full professor ((9639) 83470, juan.colado@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in inteleukin 6 (IL-6) (time frame: Pre-, mid-, and post-intervention of 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.