Effects of a Nutritional Supplement and Functional Exercise Program on Seasonal Immunity, Perceived Health, and Oxidative Stress in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in inteleukin 6 (IL-6)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Group 1: Exercise + nutritional supplement (EXNS) (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.
干预措施: Group 2: Exercise + placebo nutritional supplement (EXPlaNS) (Dietary Supplement)
结局指标
主要结局
Changes in inteleukin 6 (IL-6)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Adherence to supplement and exercise(Every day for nutritional supplement and each exercise session during the 6 months of intervention.)
- Satisfaction with the intervention(Mid- and post-intervention of 6 months)
- Change in distance covered/aerobic capacity(Pre-, mid-, and post-intervention of 6 months)
- Changes in lower limb strength(Pre-, mid-, and post-intervention of 6 months)
- Changes in agility and dynamic balance(Pre-, mid-, and post-intervention of 6 months)
- Changes in handgrip strength(Pre-, mid-, and post-intervention of 6 months)
- Changes in resting heart rate and blood pressure(Pre-, mid-, and post-intervention of 6 months)
- Demographic characteristics(Pre-, mid-, and post-intervention of 6 months)
- Changes in intraocular pressure(Pre-, mid-, and post-intervention of 6 months)
- Changes in body composition(Pre-, mid-, and post-intervention of 6 months)
- Baseline physical activity level(Pre-, mid-, and post-intervention of 6 months)
- Change in Frailty index(Pre-, mid-, and post-intervention of 6 months)
- 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)
研究者
Juan C. Colado
Professor of Physical Education
University of Valencia