A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Impact of IDP® Supplement on Respiratory Immune Health Outcomes During Cold and Flu Season in Older Individuals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Impact on Upper Respiratory Symptom Incidence, Duration and Severity
研究概览
简要总结
The primary goal of this study is to observe the impact of the IDP® Supplement on the duration and severity of upper respiratory symptoms in older individuals during the cold and flu season. Secondary aims include observing the product's effect on rescue medication use, quality of life, and overall tolerability. This is conducted as a consumer-driven, decentralized observational clinical research study in adults aged 60 or older, using self-reported measures and questionnaires completed at home via the Chloe App.
详细描述
The rationale for this study is to observe the impact of IDP® Supplement on upper respiratory tract symptoms, including duration and severity, in older individuals during the cold and flu season. Additionally, the study aims to observe the impact of the product on the type and frequency of use of rescue medication(s), the impact on individuals' activities and quality of life, and the overall tolerability of the study product. These endpoints will be assessed via activities and technologies that can successfully and effectively be completed in a home setting. A consumer-driven, decentralized observational clinical research study is therefore well-suited for examining the impact of this product in this population.
The investigators will examine the outcomes in adults aged 60 years or older who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to take the product and take part in the observational process with self-reported measures and questionnaires completed at-home using the Chloe App. Findings from this study will contribute knowledge toward the tolerability, formulation, and design of future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 60 years and older
- •Individuals who experience upper respiratory symptoms (e.g. coughing, sneezing, congestion) at least 2-3 times during the cold/flu season.
- •Able to read and understand English.
- •Able to read, understand, and provide informed consent.
- •Able to use a personal smartphone device and download Chloe by People Science.
- •Able to receive shipment of the product at an address within the United States.
排除标准
- •Any potential participants who:
- •Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- •Already in an immunocompromised state, including:
- •A. Infectious Causes
- •Chronic hepatitis B or C (advanced stages)
- •Tuberculosis (especially disseminated or extrapulmonary TB) B. Cancer-Related
- •Leukemia (e.g., AML, ALL, CLL)
- •Lymphoma (e.g., Hodgkin's and Non-Hodgkin's)
- •Multiple Myeloma
- •Any metastatic cancer receiving chemotherapy
- •C. Immunosuppressive Therapy:
- •Participants on:
- •Corticosteroids (e.g., ≥20 mg/day of prednisone for ≥2 weeks)
- •Biologics (e.g., TNF inhibitors like infliximab, adalimumab)
- •Calcineurin inhibitors (e.g., tacrolimus, cyclosporine)
- •mTOR inhibitors (e.g., sirolimus)
- •JAK inhibitors (e.g., tofacitinib)
- •Chemotherapy or radiation therapy
- •Anti-rejection meds post-organ transplant D. Transplant Patients
- •Solid organ transplant (kidney, liver, heart, lung)
- •Hematopoietic stem cell transplant (HSCT) E. Autoimmune or Inflammatory Diseases (especially when treated with immunosuppressants)
- •Rheumatoid Arthritis
- •Systemic Lupus Erythematosus (SLE)
- •Psoriasis or Psoriatic Arthritis
- •Inflammatory Bowel Disease (Crohn's disease, Ulcerative colitis)
- •Multiple Sclerosis (especially on disease-modifying therapies)
- •Other Concomitant Conditions and Therapies:
- •Any investigational therapies or treatments within 30 days prior to enrollment.
- •Known diagnosis of Asthma and/or COPD
- •Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder
- •Any underlying medical conditions or comorbidities that may confound the evaluation of the study outcomes
- •Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes
- •Use of cannabis-containing products daily
- •Use of nicotine-containing products daily
- •Known hypersensitivity or previous allergic reaction to milk products, Sorbitol and/or tabletting aids.
- •Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.
研究组 & 干预措施
Group 1: Study Product 50mg Dose
50mg of Study Product
干预措施: Immune Defense Protein 50mg Dose (Dietary Supplement)
Group 2: Study Product 200mg Dose
200mg of Study Product
干预措施: IDP 200mg Dose (Dietary Supplement)
Group 3: Matching Placebo
Participants will receive Matching Placebo
干预措施: Matching Placebo (Dietary Supplement)
结局指标
主要结局
Impact on Upper Respiratory Symptom Incidence, Duration and Severity
时间窗: 17 weeks
To evaluate the impact of IDP® Preventative Supplementation on incidence of upper respiratory symptoms, and the duration and severity of any symptoms that occur by measuring the change in incidence of upper respiratory symptoms (frequency, type, duration and severity) between study product and placebo groups. Baseline will be compared as well.
次要结局
- Impact on Rescue Medications(17 weeks)
- Safety and Tolerability Assessment(16 weeks)
- Impact of IDP on Upper Respiratory Symptoms(17 weeks)
- Impact on Quality of Life(17 weeks)