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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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,
• Пищевая добавка 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.

Первичные конечные точки

• Changes in inteleukin 6 (IL-6) [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Changes in tumor necrosis factor alfa (TNF-α) [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Changes in immunoglobulin A and G (IgA, IgG) [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Change in high-sensitivity C-reactive protein (hs-CRP) [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Complete blood count with leukocyte differential for neutrophil-to-lymphocyte ratio (NLR) calculation [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Changes in interferon gamma (IFN-γ) [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Change in F2-isoprostanes [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Change in reduced glutathione (GSH) [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Change in total antioxidant capacity (TAC) [Срок оценки: Pre-, mid-, and post-intervention of 6 months]

Вторичные конечные точки (12)

• Change in quality of life [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Change in general health perception [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Change in gastrointestinal symptoms and gut health [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Change in frequency and duration of minor illnesses [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Adherence to supplement and exercise [Срок оценки: Every day for nutritional supplement and each exercise session during the 6 months of intervention.]
• Satisfaction with the intervention [Срок оценки: Mid- and post-intervention of 6 months]
• Change in distance covered/aerobic capacity [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Changes in lower limb strength [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Changes in agility and dynamic balance [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Changes in handgrip strength [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Changes in resting heart rate and blood pressure [Срок оценки: Pre-, mid-, and post-intervention of 6 months]
• Changes in intraocular pressure [Срок оценки: Pre-, mid-, and post-intervention of 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Physical activity and Sport Science Faculty, Valencia, Valencia — Valencia

Идентификаторы

NCT: NCT07251244 · 2025-FIS-4026420

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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