LIFEHOUSE: a Lifestyle Intervention and Functional Evaluation- a Health OUtcome SurvEy; Description of the Tent Bucket -Immune Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of health.
研究概览
简要总结
This immune support program will be an extension to the existing LIFEHOUSE program. Essential employees in Gig Harbor, WA; Colonial Heights, VA; Lenexa, KS, and Santa Fe Springs, CA, will be offered complimentary supplementation with commercially available nutritional supplements supportive of immune health for several months. The outcome will be measured via blood parameters and questionnaire responses.
详细描述
This program, as a component of the LIFEHOUSE program, will consist of data collection during a period of supplementation with commercially available nutritional supplements supportive of immune health. Employees, in Gig Harbor, WA; Colonial Heights, VA; Lenexa, KS, and Santa Fe Springs, CA, will be offered the opportunity to participate.
The nutritional and inflammatory status will be captured via fingerstick biomarkers. Participants will receive in-home testing kits including instructions regarding the applicable fingerstick blood collections. Fingerstick testing will include 25-Hydroxy Vitamin D3 (25-OH D3) and high sensitivity c-reactive protein (hs-CRP) measurements at baseline, 1, and 2 (phase 1), or at baseline 1,2, 3, and 6 months intervals (phase 2).
Participants will also be asked to complete applicable questionnaires (QNs) electronically monthly using standard software programs for questionnaire completion.
This will include the Medical Outcome Study (MOS) Short Form (SF) -36 (baseline and monthly) and Health Status QNs including questions on compliance, wellbeing, lifestyle (exercise, shifts worked, medications and supplements, and diet) (baseline and monthly).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •Ages 18-69, inclusive
- •Metagenics' employees in Gig Harbor, WA; Colonial Heights, VA; Lenexa, KS, and Santa Fe Springs, CA
- •General good health
- •Willing to give written informed consent to participate in the study
排除标准
- •An allergy to any ingredient in Vit.D3 5000 and/or Immune Active
- •A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, psychiatric, immunologic/rheumatological, or oncological/hematologic disease.
- •Hyperparathyroidism
- •Granulomatous disorders including as sarcoidosis, tuberculosis, leprosy, berylliosis, histoplasmosis, and coccidioidomycosis
- •Chronic renal insufficiency
- •Nephrolithiasis
- •Prior cancer diagnosis
- •Known infection with human immunodeficiency virus (HIV), tuberculosis (TB), or Hepatitis B or C.
- •Established psychiatric disease including moderate to severe depression, thought disorders and bipolar disorder
- •Planned use of nutritional supplements (exclusive of multiple vitamin/mineral supplements and medical foods) containing in total more than 1,000 IU Vitamin D3 and/or 10 mg Zinc
- •Use of pharmaceutical nitrates for any indication
- •Use of drugs of abuse and recreational drugs/substances (such as but not limited to opioids, cocaine, phencyclidine (PCP), and methamphetamine)
- •History of marijuana or cannabinoid abuse within 12 months prior to screening and for the duration of the study.
- •History of alcohol abuse or a diagnosis of alcoholism within 12 months prior to screening and for the duration of the study.
- •Pregnant or breastfeeding women
- •Inability to comply with study and/or follow-up visits.
- •Any concurrent condition (including clinically significant abnormalities in medical history, physical examination or laboratory evaluations) which, in the opinion of the Principal Investigator (PI), would preclude safe participation in this study or interfere with compliance.
- •Any sound medical, psychiatric, and/or social reason which, in the opinion of the PI, would preclude safe participation in this study or interfere with compliance.
结局指标
主要结局
The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of health.
时间窗: 12 weeks (Phase 1) or up to 6 months (Phase 2)
The primary objective is to demonstrate the benefit of specific nutritional supplements, Vit.D3 5000 and Immune Active, as measured by demonstrable improvements in health, specifically a marker of nutritional status (25-hydroxy Vitamin D3 (25-OH D3)) and a marker of immune balance (high sensitivity c-reactive protein (hs-CRP) in a real-world setting.
次要结局
- The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of quality of life.(12 weeks (Phase 1) or up to 6 months (Phase 2))
- The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of the absence of infections.(12 weeks (Phase 1) or up to 6 months (Phase 2))
- The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of weight and body composition.(12 weeks (Phase 1) or up to 6 months (Phase 2))