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| Name | Class |
|---|---|
| MetaProteomics LLC | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immune response | Experimental | This is a single-arm study. All subjects will be treated equally and will receive the same type and amount of nutritional supplements. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vit.D3 5000 IU, Immune Active | Dietary Supplement | The subjects will receive monthly (for either 3 or 6 months):
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| Measure | Description | Time Frame |
|---|---|---|
| The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of health. | 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. | 12 weeks (Phase 1) or up to 6 months (Phase 2) |
| Measure | Description | Time Frame |
|---|---|---|
| The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of quality of life. | The first secondary objective is to demonstrate the benefit of specific nutritional supplements, Vit.D3 5000 and Immune Active, as measured by demonstrable improvements in health, specifically upon quality of life as measured by Rand Medical Outcome Study 36-Item Short Form Survey (MOS SF-36). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josesph J Lamb, MD | Medical Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Personalized Lifestyle Medicine Center | Gig Harbor | Washington | 98332 | United States |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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A single-arm cohort intervention study
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| 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. | The second secondary objective is to demonstrate the benefit of specific nutritional supplements, Vit.D3 5000 and Immune Active, as measured by demonstrable improvements in health, specifically experience-defined events (tally of well days during assessed periods and absence of laboratory-confirmed SARS-CoV-2 and Influenza 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. | The third secondary objective is to demonstrate the benefit of specific nutritional supplements, Vit.D3 5000 and Immune Active, as measured by demonstrable improvements in health, specifically in weight and body composition. | 12 weeks (Phase 1) or up to 6 months (Phase 2) |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |